{"id":991212,"date":"2024-02-23T20:59:18","date_gmt":"2024-02-23T17:59:18","guid":{"rendered":"https:\/\/lonca.com\/?post_type=amerikada-yasal-duze&#038;p=991212"},"modified":"2024-02-23T21:09:24","modified_gmt":"2024-02-23T18:09:24","slug":"kozmetik-etiketleme-kilavuzu","status":"publish","type":"amerikada-yasal-duze","link":"https:\/\/lonca.com\/en\/amerikada-yasal-duze\/kozmetik-etiketleme-kilavuzu\/","title":{"rendered":"KOZMET\u0130K ET\u0130KETLEME KILAVUZU"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"991212\" class=\"elementor elementor-991212\" data-elementor-post-type=\"amerikada-yasal-duze\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2ea1046 e-flex e-con-boxed e-con e-parent\" data-id=\"2ea1046\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f49f01f elementor-widget elementor-widget-text-editor\" data-id=\"f49f01f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<span>PDF format\u0131nda mevcut\u00a0<\/span><a href=\"https:\/\/www.fda.gov\/media\/88234\/download\" target=\"\" rel=\"nofollow noopener\"><span>(316KB)<\/span><\/a>\n\n<span>Kozmetik Etiketleme K\u0131lavuzu, \u00fcreticilerin ABD yasalar\u0131 ve ilgili d\u00fczenlemeler kapsam\u0131ndaki etiketleme gereklilikleri hakk\u0131nda s\u0131kl\u0131kla sordu\u011fu sorular\u0131n \u00f6rnekleri ve yan\u0131tlar\u0131yla birlikte, kozmetik etiketlemeyle ilgili ad\u0131m ad\u0131m yard\u0131m sa\u011flar.<\/span>\n\n<span>Bu sayfada:<\/span>\n<ul>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clga\" target=\"_blank\" rel=\"noopener\"><span>Kozmetik Etiketlemeyi D\u00fczenleyen Kanunlar<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgb\" rel=\"nofollow noopener\" target=\"_blank\"><span>Terimlerin Yasal Tan\u0131mlar\u0131<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgc\" rel=\"nofollow noopener\" target=\"_blank\"><span>Ana G\u00f6sterge Paneli<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgd\" rel=\"nofollow noopener\" target=\"_blank\"><span>Bilgilerin Etiketler \u00dczerine Yerle\u015ftirilmesi<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clge\" rel=\"nofollow noopener\" target=\"_blank\"><span>\u00d6ne \u00c7\u0131kma ve G\u00f6ze \u00c7arpma<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgf\" target=\"_blank\" rel=\"noopener\"><span>Dil<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgg\" target=\"_blank\" rel=\"noopener\"><span>Tip Boyut<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgh\" rel=\"nofollow noopener\" target=\"_blank\"><span>Kimlik Etiketleme<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgi\" rel=\"nofollow noopener\" target=\"_blank\"><span>Ad\u0131 ve \u0130\u015f Yeri<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgj\" rel=\"nofollow noopener\" target=\"_blank\"><span>Net \u0130\u00e7erik Beyan\u0131 Miktar\u0131<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgk\" rel=\"nofollow noopener\" target=\"_blank\"><span>Uyar\u0131 A\u00e7\u0131klamalar\u0131<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl\" target=\"_blank\" rel=\"noopener\"><span>\u0130\u00e7erik Etiketlemesi<\/span><\/a>\n<ul>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl1\" rel=\"nofollow noopener\" target=\"_blank\"><span>\u00d6nem<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl2\" rel=\"nofollow noopener\" target=\"_blank\"><span>\u0130\u00e7erik Tan\u0131mlamas\u0131<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl3\" target=\"_blank\" rel=\"noopener\"><span>Beyan S\u0131ras\u0131<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl4\" rel=\"nofollow noopener\" target=\"_blank\"><span>Kokular ve Tatlar<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl5\" rel=\"nofollow noopener\" target=\"_blank\"><span>Ticari S\u0131r Malzemeler<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl6\" rel=\"nofollow noopener\" target=\"_blank\"><span>Ticaret Gizlili\u011fi Dilek\u00e7esi<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl7\" target=\"_blank\" rel=\"noopener\"><span>\u0130la\u00e7 \u0130\u00e7erikleri<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl8\" rel=\"nofollow noopener\" target=\"_blank\"><span>Renk E\u015fle\u015ftirme \u0130\u00e7in Eklenen Renk Katk\u0131 Maddeleri<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl9\" rel=\"nofollow noopener\" target=\"_blank\"><span>Tesad\u00fcfi Malzemeler<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl10\" rel=\"nofollow noopener\" target=\"_blank\"><span>Farkl\u0131 \u00dcr\u00fcn \u00c7e\u015fitleri<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl11\" rel=\"nofollow noopener\" target=\"_blank\"><span>Benzer \u00dcr\u00fcn \u00c7e\u015fitleri<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl12\" rel=\"nofollow noopener\" target=\"_blank\"><span>Markal\u0131 G\u00f6lge \u00c7izgileri<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl13\" rel=\"nofollow noopener\" target=\"_blank\"><span>Do\u011frudan Posta Kozmetikleri<\/span><\/a><\/li>\n \t<li><a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#clgl14\" rel=\"nofollow noopener\" target=\"_blank\"><span>Paket D\u0131\u015f\u0131 \u0130\u00e7erik Etiketlemesi<\/span><\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n<hr \/>\n\n<b><span>De\u011fi\u015ftirilen \u015fekliyle 1938 tarihli Federal G\u0131da, \u0130la\u00e7 ve Kozmetik Yasas\u0131<\/span><a id=\"clga\" name=\"clga\"><\/a><\/b>\n\n<strong><span>Katk\u0131l\u0131 veya yanl\u0131\u015f markalanm\u0131\u015f g\u0131da, ila\u00e7, cihaz ve kozmetik \u00fcr\u00fcnlerinin eyaletler aras\u0131 ticaretini yasaklayarak t\u00fcketicileri g\u00fcvensiz veya aldat\u0131c\u0131 \u015fekilde etiketlenmi\u015f veya paketlenmi\u015f \u00fcr\u00fcnlerden korumak.<\/span><\/strong>\n\n<strong><span>21USC321-392<\/span><\/strong>\n\n<span>Amerika Birle\u015fik Devletleri&#8217;nde pazarlanan kozmetikler, ister burada \u00fcretilmi\u015f ister yurt d\u0131\u015f\u0131ndan ithal edilmi\u015f olsun, Federal G\u0131da, \u0130la\u00e7 ve Kozmetik (FD&amp;C) Yasas\u0131, Adil Paketleme ve Etiketleme (FP&amp;L) Yasas\u0131 ve Adil Paketleme ve Etiketleme (FP&amp;L) Yasas\u0131n\u0131n etiketleme gerekliliklerine uygun olmal\u0131d\u0131r. Bu iki kanunun yetkisinde G\u0131da ve \u0130la\u00e7 \u0130daresi taraf\u0131ndan yay\u0131mlanan y\u00f6netmelikler.<\/span>\n\n<span>FD&amp;C Yasas\u0131, sahte veya yanl\u0131\u015f markalanm\u0131\u015f g\u0131da, ila\u00e7 cihazlar\u0131 ve kozmetik \u00fcr\u00fcnlerinin eyaletler aras\u0131 ticaretini yasaklayarak t\u00fcketicileri g\u00fcvensiz veya aldat\u0131c\u0131 \u015fekilde etiketlenmi\u015f veya paketlenmi\u015f \u00fcr\u00fcnlerden korumak amac\u0131yla Kongre taraf\u0131ndan y\u00fcr\u00fcrl\u00fc\u011fe girmi\u015ftir.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Adil Paketleme ve Etiketleme Yasas\u0131<\/span><\/b>\n\n<strong><span>Ambalajlar\u0131n ve etiketlerinin t\u00fcketicilere i\u00e7erik miktar\u0131 hakk\u0131nda do\u011fru bilgi vermesini sa\u011flamak ve de\u011fer kar\u015f\u0131la\u015ft\u0131rmalar\u0131n\u0131 kolayla\u015ft\u0131rmak.<\/span><\/strong>\n\n<strong><span>15USC1451-1460<\/span><\/strong>\n\n<span>FP&amp;L Yasas\u0131, paketlerin ve etiketlerinin t\u00fcketicilere i\u00e7erik miktar\u0131 hakk\u0131nda do\u011fru bilgi vermesini ve de\u011fer kar\u015f\u0131la\u015ft\u0131rmalar\u0131n\u0131 kolayla\u015ft\u0131rmas\u0131n\u0131 sa\u011flamak i\u00e7in Kongre taraf\u0131ndan kabul edildi.<\/span>\n\n<hr \/>\n\n<b><span>Federal G\u0131da, \u0130la\u00e7 ve Kozmetik Yasas\u0131<\/span><\/b>\n\n<strong><span>FD&amp;C Yasas\u0131, sahte veya yanl\u0131\u015f markalanm\u0131\u015f kozmetiklerin pazarlanmas\u0131n\u0131 ve bunlar\u0131n eyaletler aras\u0131 ticarette ta\u011f\u015fi\u015f veya yanl\u0131\u015f markalanmas\u0131n\u0131 yasaklar.<\/span><\/strong>\n\n<strong><span>saniye.\u00a0301, FD&amp;C Yasas\u0131<\/span><\/strong>\n\n<span>FD&amp;C Yasas\u0131, sahte veya yanl\u0131\u015f markalanm\u0131\u015f kozmetiklerin pazarlanmas\u0131n\u0131 ve bunlar\u0131n eyaletler aras\u0131 ticarette ta\u011f\u015fi\u015f veya yanl\u0131\u015f markalanmas\u0131n\u0131 yasaklar.<\/span>\n\n<hr \/>\n\n<b><span>Bir kozmetik a\u015fa\u011f\u0131daki durumlarda yanl\u0131\u015f markalanm\u0131\u015f olarak kabul edilir:<\/span><\/b>\n<ul>\n \t<li><strong><span>etiketleme yanl\u0131\u015f veya yan\u0131lt\u0131c\u0131<\/span><\/strong><\/li>\n \t<li><strong><span>etiket belirtmiyor<\/span><\/strong>\n<ul>\n \t<li><strong><span>\u00fcreticinin, paketleyicinin veya distrib\u00fct\u00f6r\u00fcn ad\u0131 ve adresi<\/span><\/strong><\/li>\n \t<li><strong><span>net i\u00e7erik miktar\u0131<\/span><\/strong><\/li>\n<\/ul>\n<\/li>\n \t<li><strong><span>gerekli bilgilerin belirgin, dikkat \u00e7ekici ve al\u0131\u015f\u0131lagelmi\u015f sat\u0131n alma ve kullan\u0131m ko\u015fullar\u0131 alt\u0131nda t\u00fcketiciler taraf\u0131ndan okunup anla\u015f\u0131lacak \u015fekilde belirtilmemesi<\/span><\/strong><\/li>\n \t<li><strong><span>kap veya dolumu yan\u0131lt\u0131c\u0131<\/span><\/strong><\/li>\n<\/ul>\n<strong><span>saniye.\u00a0602, FD&amp;C Yasas\u0131\u00a0<\/span><\/strong>\n\n<span>saniye.\u00a0FD&amp;C Yasas\u0131&#8217;n\u0131n 602&#8217;si, bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn yanl\u0131\u015f markalanm\u0131\u015f say\u0131lmas\u0131na neden olan ko\u015fullar\u0131 tan\u0131mlamaktad\u0131r.<\/span>\n\n<hr \/>\n\n<b><span>Etiketlemenin Yan\u0131lt\u0131c\u0131 Olup Olmad\u0131\u011f\u0131n\u0131 Belirleyen Fakt\u00f6rler<\/span><\/b>\n<ol>\n \t<li><strong><span>Yap\u0131lan veya \u00f6nerilen beyanlar<\/span><\/strong><\/li>\n \t<li><strong><span>Maddi ger\u00e7eklerin a\u00e7\u0131klanmamas\u0131:<\/span><\/strong>\n<ol type=\"a\">\n \t<li><strong><span>Bu t\u00fcr temsillerin \u0131\u015f\u0131\u011f\u0131nda materyal<\/span><\/strong><\/li>\n \t<li><strong><span>Ama\u00e7lanan kullan\u0131mdan kaynaklanan sonu\u00e7lara ili\u015fkin materyal<\/span><\/strong><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<strong><span>saniye.\u00a0201(n), FD&amp;C Yasas\u0131<\/span>\n<span>21 CFR 1.21<\/span><\/strong>\n\n<span>Etiketleme, yaln\u0131zca etiket beyan\u0131n\u0131n aldat\u0131c\u0131 olmas\u0131 nedeniyle de\u011fil, ayn\u0131 zamanda etikette \u00f6nemli bir ger\u00e7e\u011fin a\u00e7\u0131klanmamas\u0131 nedeniyle de yan\u0131lt\u0131c\u0131 olarak de\u011ferlendirilebilir.<\/span>\n\n<span>Bir olgu, etikette yer alan bir ifadenin \u0131\u015f\u0131\u011f\u0131nda veya bir \u00fcr\u00fcn\u00fcn tavsiye edilen kullan\u0131m\u0131ndan kaynaklanabilecek belirli sonu\u00e7lar nedeniyle \u00f6nemli olabilir.<\/span>\n\n<hr \/>\n\n<b><span>Kozmetik nedir?<\/span><a id=\"clgb\" name=\"clgb\"><\/a><\/b>\n\n<strong><span>Kozmetik, sabun d\u0131\u015f\u0131nda, insan v\u00fccuduna temizleme, g\u00fczelle\u015ftirme, \u00e7ekicili\u011fi art\u0131rma veya g\u00f6r\u00fcn\u00fcm\u00fc de\u011fi\u015ftirme amac\u0131yla uygulanan bir \u00fcr\u00fcnd\u00fcr.<\/span><\/strong>\n\n<strong><span>saniye.\u00a0201(i) FD&amp;C Yasas\u0131\u00a0<\/span><\/strong>\n\n<span>FD&amp;C Yasas\u0131n\u0131n 201(i) b\u00f6l\u00fcm\u00fcnde tan\u0131mland\u0131\u011f\u0131 gibi kozmetik, sabun d\u0131\u015f\u0131nda, temizlemek, g\u00fczelle\u015ftirmek, \u00e7ekicili\u011fi art\u0131rmak veya g\u00f6r\u00fcn\u00fcm\u00fc de\u011fi\u015ftirmek amac\u0131yla insan v\u00fccuduna uygulanmas\u0131 ama\u00e7lanan bir \u00fcr\u00fcnd\u00fcr.<\/span>\n\n<span>K\u0131saca kozmeti\u011fin insan v\u00fccudu \u00fczerinde fizyolojik de\u011fil fiziksel bir etki yaratmas\u0131 ama\u00e7lanan bir \u00fcr\u00fcn oldu\u011fu s\u00f6ylenebilir.<\/span>\n\n<span>Kozmetik \u00fcr\u00fcnlerin i\u00e7eri\u011finde kullan\u0131lan hammaddeler de kanunen kozmetiktir.<\/span>\n\n<span>Federal Y\u00f6netmelikler Kanununun [21 CFR 701.20] Ba\u015fl\u0131k 21&#8217;inin 701.20 numaral\u0131 b\u00f6l\u00fcm\u00fcnde, G\u0131da ve \u0130la\u00e7 \u0130daresi (FDA), &#8220;sabun&#8221; terimini, u\u00e7ucu olmayan k\u0131sm\u0131n\u0131n esas olarak ya\u011fl\u0131 bir alkali tuzdan olu\u015ftu\u011fu bir \u00fcr\u00fcn olarak tan\u0131mlar. asitler, yani sabunun geleneksel bile\u015fimi;\u00a0\u00fcr\u00fcn sabun olarak etiketlenmi\u015ftir;\u00a0ve etiket ifadeleri yaln\u0131zca temizli\u011fe at\u0131fta bulunur.\u00a0Bir etiket \u00fczerinde nemlendirici, koku giderici, cildi yumu\u015fat\u0131c\u0131 vb. gibi kozmetik iddialarda bulunuluyorsa, \u00fcr\u00fcn kozmetiktir.\u00a0Sentetik deterjan \u00e7ubuklar\u0131 da kozmetik olarak kabul edilir, ancak &#8220;sabun&#8221; olarak etiketlenebilirler.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><strong><span>FD&amp;C Yasas\u0131 anlam\u0131nda &#8220;ama\u00e7lanan kullan\u0131m&#8221;, etiketine veya etiketlemesine g\u00f6re belirlenir.<\/span><\/strong><\/b>\n\n<strong><span>Senato Raporu No. 493<\/span>\n<span>73d Cong.\u00a02. Oturum.\u00a0(1934)<\/span>\n<span>ABD Temyiz Mahkemeleri Kararlar\u0131<\/span><\/strong>\n\n<span>493 Say\u0131l\u0131 Senato Raporuna ve mahkeme kararlar\u0131na g\u00f6re, &#8220;kozmetik&#8221; teriminin hukuki tan\u0131m\u0131nda veya di\u011fer tan\u0131mlardaki &#8220;ama\u00e7lanan&#8221; terimi, bir \u00fcr\u00fcn\u00fcn kullan\u0131m\u0131na ili\u015fkin olarak, onun Y\u00f6netmelikte belirlenen veya \u00f6ng\u00f6r\u00fclen kullan\u0131m\u0131 anlam\u0131na gelir. Bir \u00fcr\u00fcn\u00fcn etiketinde veya etiketinde yer alan ifadeler.<\/span>\n\n<span>Mahkemeler, bir \u00fcr\u00fcn\u00fcn &#8220;kozmetik&#8221; mi, &#8220;ila\u00e7&#8221; m\u0131, yoksa hem &#8220;ila\u00e7&#8221; hem de &#8220;kozmetik&#8221; olup olmad\u0131\u011f\u0131na karar verirken esas olarak t\u00fcketicinin etiket beyan\u0131n\u0131n anlam\u0131na ili\u015fkin alg\u0131s\u0131na ve daha az olarak da etiket beyan\u0131na dayanm\u0131\u015ft\u0131r. Etiket beyan\u0131n\u0131n anlam\u0131n\u0131n etiketleyici veya d\u00fczenleyici kurum taraf\u0131ndan yorumlanmas\u0131.<\/span>\n\n<hr \/>\n\n<b><span>Kozmetik ne zaman ayn\u0131 zamanda ila\u00e7 olur?<\/span><\/b>\n\n<strong><span>Kozmetik, temizleme, g\u00fczelle\u015ftirme veya \u00e7ekicili\u011fi artt\u0131rman\u0131n yan\u0131 s\u0131ra hastal\u0131klar\u0131 tedavi etmek veya \u00f6nlemek veya insan v\u00fccudunun yap\u0131s\u0131n\u0131 veya herhangi bir i\u015flevini ba\u015fka \u015fekilde etkilemek ama\u00e7land\u0131\u011f\u0131nda da bir ila\u00e7t\u0131r.<\/span><\/strong>\n\n<strong><span>saniye.\u00a0201(g) ve (i), FD&amp;C Kanunu<\/span>\n<span>B\u00f6l\u00fcm.\u00a0509, FD&amp;C Yasas\u0131<\/span><\/strong>\n\n<span>FD&amp;C Yasas\u0131 b\u00f6l\u00fcm 201(g)&#8217;de &#8220;ila\u00e7&#8221; terimini, di\u011fer \u015feylerin yan\u0131 s\u0131ra, &#8220;ila\u00e7&#8221; terimini, di\u011fer \u015feylerin yan\u0131 s\u0131ra, &#8220;kozmetikte kullan\u0131lmas\u0131 ama\u00e7lanan \u00fcr\u00fcnler&#8221; olarak tan\u0131mlad\u0131\u011f\u0131ndan, bir kozmetik hem fiziksel hem de fizyolojik bir etki yaratmay\u0131 ama\u00e7l\u0131yorsa yasal olarak bir ila\u00e7t\u0131r. &#8230; hastal\u0131\u011f\u0131n tedavisi, hafifletilmesi, tedavi edilmesi veya \u00f6nlenmesi &#8230; ve &#8230; v\u00fccudun yap\u0131s\u0131n\u0131 veya herhangi bir fonksiyonunu etkilemeyi ama\u00e7layan e\u015fyalar &#8230;&#8221;<\/span>\n\n<span>FD&amp;C Yasas\u0131n\u0131n 509. Maddesi, &#8220;ila\u00e7&#8221; ve &#8220;kozmetik&#8221; kategorilerinin birbirini d\u0131\u015flamad\u0131\u011f\u0131n\u0131 \u00f6ng\u00f6rmektedir.<\/span>\n\n<hr \/>\n\n<b><span>T\u00fcketim mal\u0131 nedir?<\/span><\/b>\n\n<strong><span>T\u00fcketicilerin kullan\u0131m\u0131 veya evdeki hizmetlerin yerine getirilmesi i\u00e7in geleneksel olarak perakende sat\u0131\u015f amac\u0131yla da\u011f\u0131t\u0131lan ve genellikle bu kullan\u0131m s\u0131ras\u0131nda t\u00fcketilen bir \u00fcr\u00fcnd\u00fcr.<\/span><\/strong>\n\n<strong><span>saniye.\u00a010(a), FP&amp;L Yasas\u0131.<\/span><\/strong>\n\n<span>FD&amp;C Yasas\u0131 b\u00f6l\u00fcm 201(g)&#8217;de &#8220;ila\u00e7&#8221; terimini, di\u011fer \u015feylerin yan\u0131 s\u0131ra, &#8220;ila\u00e7&#8221; terimini, di\u011fer \u015feylerin yan\u0131 s\u0131ra, &#8220;kozmetikte kullan\u0131lmas\u0131 ama\u00e7lanan \u00fcr\u00fcnler&#8221; olarak tan\u0131mlad\u0131\u011f\u0131ndan, bir kozmetik hem fiziksel hem de fizyolojik bir etki yaratmay\u0131 ama\u00e7l\u0131yorsa yasal olarak bir ila\u00e7t\u0131r. &#8230; hastal\u0131\u011f\u0131n tedavisi, hafifletilmesi, tedavi edilmesi veya \u00f6nlenmesi &#8230; ve &#8230; v\u00fccudun yap\u0131s\u0131n\u0131 veya herhangi bir fonksiyonunu etkilemeyi ama\u00e7layan e\u015fyalar &#8230;&#8221;<\/span>\n\n<span>FD&amp;C Yasas\u0131n\u0131n 509. Maddesi, &#8220;ila\u00e7&#8221; ve &#8220;kozmetik&#8221; kategorilerinin birbirini d\u0131\u015flamad\u0131\u011f\u0131n\u0131 \u00f6ng\u00f6rmektedir.<\/span>\n\n<hr \/>\n\n<b><span>Paket<\/span><\/b>\n\n<strong><span>Bir t\u00fcketim mal\u0131n\u0131n perakende al\u0131c\u0131lara teslim edildi\u011fi veya sergilendi\u011fi, nakliye konteyneri veya ambalaj\u0131 d\u0131\u015f\u0131nda bir kap veya ambalaj.<\/span><\/strong>\n\n<strong><span>saniye.\u00a010(b), FP&amp;L Yasas\u0131<\/span>\n<span>21 CFR 1.20<\/span><\/strong>\n\n<span>Paket terimi, Adil Paketleme ve Etiketleme Yasas\u0131nda [sn.\u00a010(b)] ve Federal Y\u00f6netmelikler Kanunu [21 CFR 1.20].<\/span>\n\n<span>Temel olarak &#8220;paket&#8221;, \u00f6rne\u011fin bir kutu veya katlan\u0131r karton gibi bir \u00fcr\u00fcn\u00fcn d\u0131\u015f kab\u0131d\u0131r.\u00a0Bununla birlikte, &#8220;paket&#8221; ayn\u0131 zamanda, e\u011fer yak\u0131n kap bir kutu veya katlan\u0131r karton i\u00e7inde sergilenmiyorsa, \u00fcr\u00fcn\u00fc tutan \u00f6rne\u011fin \u015fi\u015fe, kavanoz veya aerosol kutusu gibi do\u011frudan kap da olabilir.<\/span>\n\n<hr \/>\n\n<b><span>Etiket<\/span><\/b>\n\n<strong><span>Bilginin yaz\u0131l\u0131, bas\u0131l\u0131 veya grafiksel g\u00f6sterimi&#8230;<\/span><\/strong>\n<ul>\n \t<li><strong><span>bir kozmetik kutusunun \u00fczerinde<\/span><\/strong><\/li>\n<\/ul>\n<strong><span>saniye.\u00a0201(k), FD&amp;C Yasas\u0131.<\/span><\/strong>\n<ul>\n \t<li><strong><span>t\u00fcketim mal\u0131 i\u00e7eren bir pakete yap\u0131\u015ft\u0131r\u0131lm\u0131\u015f veya \u00fczerinde g\u00f6r\u00fcnen<\/span><\/strong><\/li>\n<\/ul>\n<strong><span>saniye.\u00a010(c), FP&amp;L Yasas\u0131<\/span>\n<span>21 CFR 1.3(b)<\/span><\/strong>\n\n<span>&#8220;Etiket&#8221; terimi FD&amp;C Yasas\u0131 ve FP&amp;L Yasas\u0131nda tan\u0131mlanm\u0131\u015ft\u0131r.\u00a0Tan\u0131mlar, FD&amp;C Yasas\u0131 tan\u0131m\u0131na g\u00f6re bir etiketin &#8220;hemen ambalaj\u0131n \u00fczerindeki yaz\u0131l\u0131, bas\u0131l\u0131 veya grafik materyalin g\u00f6sterimi&#8221; olmas\u0131 ve FP&amp;L Yasas\u0131 tan\u0131m\u0131na g\u00f6re &#8220;herhangi bir t\u00fcketici \u00fcr\u00fcn\u00fcne yap\u0131\u015ft\u0131r\u0131lan veya t\u00fcketici \u00fcr\u00fcn\u00fcne ili\u015ftirilen yaz\u0131l\u0131, bas\u0131l\u0131 veya grafik malzeme&#8221; olmas\u0131 bak\u0131m\u0131ndan farkl\u0131l\u0131k g\u00f6sterir. veya herhangi bir t\u00fcketim mal\u0131 i\u00e7eren bir paketin \u00fczerinde g\u00f6r\u00fcnmesi.&#8221;<\/span>\n\n<span>&#8220;Etiket&#8221; teriminin ilk durumda do\u011frudan i\u00e7 kab\u0131n \u00fczerinde g\u00f6r\u00fcnen bilgiye, ikinci durumda ise yak\u0131n kaba ili\u015ftirilen ve e\u011fer ambalajlanm\u0131\u015fsa do\u011frudan d\u0131\u015f kab\u0131n \u00fczerine veya ona ili\u015ftirilen bilgiye uyguland\u0131\u011f\u0131 s\u00f6ylenebilir.<\/span>\n\n<span>Ancak FD&amp;C Yasas\u0131, b\u00f6l\u00fcm 201(k)&#8217;de, ambalaj\u0131n etiketinde yer almas\u0131 gereken herhangi bir bilginin perakende paketin d\u0131\u015f ambalaj\u0131nda \u200b\u200bda yer almas\u0131n\u0131 veya d\u0131\u015f ambalajdan okunabilmesini gerektirmektedir.<\/span>\n\n<hr \/>\n\n<b><span>Etiketleme<\/span><\/b>\n\n<strong><span>Eyaletleraras\u0131 ticarette veya sat\u0131\u015f amac\u0131yla elde tutulan bir \u00fcr\u00fcn\u00fcn \u00fczerinde veya beraberindeki t\u00fcm etiketler ve di\u011fer yaz\u0131l\u0131, bas\u0131l\u0131 veya grafik materyaller<\/span><\/strong>\n\n<strong><span>saniye.\u00a0201(m), FD&amp;C Yasas\u0131<\/span>\n<span>21 CFR 1.3(a)<\/span><\/strong>\n\n<span>FD&amp;C Yasas\u0131 saniyede tan\u0131mlar.\u00a0201(m) &#8220;etiketleme&#8221;, &#8220;bu t\u00fcr bir \u00fcr\u00fcn\u00fcn \u00fczerinde veya ona e\u015flik eden t\u00fcm etiketler ve di\u011fer yaz\u0131l\u0131, bas\u0131l\u0131 veya grafik materyaller&#8221; anlam\u0131na gelir.<\/span>\n\n<span>Bu, bir \u00fcr\u00fcnle birlikte da\u011f\u0131t\u0131lan etiketleri, ekleri, y\u00fckselticileri, te\u015fhir paketlerini, kitap\u00e7\u0131klar\u0131, tan\u0131t\u0131m literat\u00fcr\u00fcn\u00fc veya di\u011fer yaz\u0131l\u0131 veya bas\u0131l\u0131 bilgileri i\u00e7erir.<\/span>\n\n<hr \/>\n\n<b><span>Ana G\u00f6sterge Paneli<\/span><a id=\"clgc\" name=\"clgc\"><\/a><\/b>\n\n<strong><span>Etiketin perakende sat\u0131\u015fa sunuldu\u011funda t\u00fcketicinin g\u00f6rd\u00fc\u011f\u00fc veya inceledi\u011fi k\u0131sm\u0131<\/span><\/strong>\n\n<strong><span>saniye.\u00a010(t), FP&amp;L Yasas\u0131<\/span>\n<span>21 CFR 701.10<\/span><\/strong>\n\n<span>Bir etiket birden fazla panelden olu\u015fabilir.\u00a0Bir \u00f6n panel, yan paneller ve bir arka panelden olu\u015fabilir.\u00a0Arka ve yan panellere genel olarak bilgi panelleri ad\u0131 verilmektedir.<\/span>\n\n<span>FP&amp;L Yasas\u0131 ayr\u0131ca t\u00fcketici mallar\u0131 veya bir t\u00fcketim mal\u0131 i\u00e7eren paketler i\u00e7in, k\u0131saca PDP olarak bilinen &#8220;ana te\u015fhir paneli&#8221; terimini de tan\u0131mlar.<\/span>\n\n<span>&#8220;Ana te\u015fhir paneli&#8221;, bir panelin perakende sat\u0131\u015f i\u00e7in al\u0131\u015f\u0131lagelmi\u015f te\u015fhir ko\u015fullar\u0131 alt\u0131nda g\u00f6sterilmesi veya incelenmesi en muhtemel olan k\u0131sm\u0131d\u0131r.\u00a0Genellikle d\u0131\u015f ambalaj\u0131n etiketinin \u00f6n panelidir.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Ana Ekran Panelinin Yerle\u015fimi ve Boyutu<\/span><\/b>\n\n<strong><span>Konum<\/span>\n<span>Boyutu<\/span>\n<span>\u00c7oklu PDP<\/span>\n\n<em><span>\u0130stisnalar<\/span><\/em>\n\n<span>Dekoratif kaplar<\/span>\n<span>Kompaktlar veya kalemler<\/span>\n<span>1\/4 av.\u00a0oz.\u00a0veya 1\/8 fl.\u00a0oz.\u00a0kapasite<\/span>\n<span>Ekran kartlar\u0131<\/span><\/strong>\n\n<strong><span>21 CFR 701.10 ve 701.13(e)<\/span><\/strong>\n\n<span>Daha \u00f6nce de belirtildi\u011fi gibi, KAP, etiketin perakende sat\u0131\u015fta al\u0131\u015f\u0131lagelmi\u015f ko\u015fullar alt\u0131nda g\u00f6sterilmesi veya incelenmesi en muhtemel olan k\u0131sm\u0131d\u0131r.<\/span>\n\n<span>FDA taraf\u0131ndan yay\u0131nlanan d\u00fczenlemeler [21 CFR 701.10], PDP&#8217;nin gerekli t\u00fcm etiket bilgilerini net ve dikkat \u00e7ekici bir \u015fekilde bar\u0131nd\u0131racak kadar b\u00fcy\u00fck olmas\u0131n\u0131 gerektirir.<\/span>\n\n<span>Bir paketin birden fazla KAP&#8217;\u0131 olmas\u0131 durumunda, KAP&#8217;ta yer almas\u0131 gereken bilgilerin t\u00fcm KAP&#8217;larda \u00e7o\u011falt\u0131lmas\u0131 gerekmektedir.<\/span>\n\n<span>Bir \u00fcr\u00fcn\u00fcn net i\u00e7erik miktar\u0131n\u0131 beyan etmek i\u00e7in tek tip tip boyutunun sa\u011flanmas\u0131 amac\u0131yla, belirleyici fakt\u00f6r PDP&#8217;nin kendisinin boyutu de\u011fil, PDP&#8217;yi ta\u015f\u0131yan y\u00fczey alan\u0131n\u0131n boyutudur.\u00a0PDP&#8217;nin alan\u0131 \u015funlar i\u00e7indir:<\/span>\n\n<span>Dikd\u00f6rtgen paket: Bir taraf\u0131n tamam\u0131.<\/span>\n\n<span>Silindirik paket: Y\u00fcksekli\u011fin %40&#8217;\u0131 x \u00e7evre.<\/span>\n\n<span>Di\u011fer herhangi bir konteyner \u015fekli: \u00dcst, alt, boyun, omuz ve flan\u015flar hari\u00e7 toplam konteyner y\u00fczeyinin %40&#8217;\u0131.<\/span>\n\n<span>&#8220;Yatak odas\u0131 tipi&#8221; veya dekoratif kozmetik kab\u0131n\u0131n (\u00f6rne\u011fin, kartu\u015f, hap kutusu, kompakt veya \u00f6zel \u00e7e\u015fit) PDP&#8217;si ve 1\/4 oz veya daha az i\u00e7erenler, kaba yap\u0131\u015ft\u0131r\u0131lm\u0131\u015f y\u0131rt\u0131labilir bir etiket veya bant olabilir [21 CFR 701.13(e)(1)].\u00a0Ayn\u0131 zamanda, yak\u0131n kab\u0131n tak\u0131ld\u0131\u011f\u0131 bir kart\u0131n g\u00f6r\u00fcnt\u00fc paneli de olabilir [21 CFR 701.13(e)(2)].<\/span>\n\n<hr \/>\n\n<b><span>Bilgilerin Etiketler \u00dczerine Yerle\u015ftirilmesi<\/span><a id=\"clgd\" name=\"clgd\"><\/a><\/b>\n\n<strong><span>D\u0131\u015f Konteyner<\/span>\n<span>(Veya Tek Konteyner \u00dcr\u00fcn\u00fcn Etiketi)<\/span><\/strong>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" summary=\"display\">\n<thead>\n<tr>\n<th scope=\"col\" valign=\"top\"><span>Ana G\u00f6sterge Paneli:<\/span>\n\n<span>\u00dcr\u00fcn\u00fcn ad\u0131<\/span>\n\n<strong><span>Kimlik<\/span><\/strong>\n\n<strong><span>\u00a7 740.10 uyar\u0131s\u0131<\/span><\/strong>\n\n<strong><span>Net i\u00e7erik miktar\u0131<\/span><\/strong><\/th>\n<th scope=\"col\" valign=\"top\"><span>Bilgi Panelleri:<\/span>\n\n<span>G\u00fcvenli kullan\u0131m i\u00e7in talimatlar<\/span>\n\n<strong><span>Uyar\u0131lar<\/span><\/strong>\n\n<strong><span>Ad\u0131 ve i\u015f yeri<\/span><\/strong>\n\n<strong><span>\u0130\u00e7erik beyan\u0131<\/span><\/strong>\n\n<strong><span>Gerekli di\u011fer bilgiler<\/span><\/strong><\/th>\n<\/tr>\n<\/thead>\n<\/table>\n<span>Yukar\u0131daki bilgiler, genellikle i\u00e7 (hemen) kab\u0131 tutan bir kutu, katlan\u0131r karton, ambalaj ka\u011f\u0131d\u0131 vb. olan d\u0131\u015f kab\u0131n etiketinde g\u00f6r\u00fcnmelidir.\u00a0Kozmetik \u00fcr\u00fcn\u00fcn bulundu\u011fu i\u00e7 kap ayn\u0131 zamanda bir kutu, katlan\u0131r karton vb. i\u00e7inde sergilenmiyorsa d\u0131\u015f kapt\u0131r.<\/span>\n\n<span>Yaln\u0131zca d\u0131\u015f kab\u0131n etiketinin PDP&#8217;ye sahip oldu\u011funu l\u00fctfen unutmay\u0131n.<\/span>\n\n<span>\u00dcr\u00fcn\u00fcn marka ad\u0131n\u0131n belirtilmesi, FD&amp;C veya FP&amp;L Yasas\u0131 kapsam\u0131nda d\u00fczenleyici bir gereklilik de\u011fildir.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Bilgilerin<\/span>\n<span>\u0130\u00e7 Kap \u00dczerine Yerle\u015ftirilmesi (D\u0131\u015f Kapta Paketlenmi\u015fse)<\/span><\/b>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" summary=\"display\">\n<thead>\n<tr>\n<th scope=\"col\"><span>\u00d6n panel<\/span><\/th>\n<th scope=\"col\"><span>Bilgi Panelleri<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u00a0<\/strong><\/td>\n<td><strong><span>G\u00fcvenli kullan\u0131m i\u00e7in talimatlar<\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>\u00a0<\/strong><\/td>\n<td><strong><span>Uyar\u0131lar<\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong><span>\u00dcr\u00fcn Ad\u0131<\/span><\/strong><\/td>\n<td><strong><span>Ad\u0131 ve \u0130\u015f Yeri<\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>\u00a0<\/strong><\/td>\n<td><strong><span>Net \u0130\u00e7erik Miktar\u0131<\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>\u00a0<\/strong><\/td>\n<td><strong><span>Gerekli Di\u011fer Bilgiler<\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span>Yukar\u0131daki bilgiler kozmetik \u00fcr\u00fcn\u00fcn bulundu\u011fu i\u00e7 (haz\u0131r) kab\u0131n etiketi \u00fczerinde yer almal\u0131d\u0131r.\u00a0\u0130\u00e7 kap \u015feffaf olmayan bir kutu, katlan\u0131r karton vb. i\u00e7erisinde paketlenir ve sergilenir. D\u0131\u015f kap \u00e7\u0131kar\u0131l\u0131rsa ve \u00fcr\u00fcn onsuz sat\u0131\u015fa sunulursa, hemen yan\u0131ndaki kab\u0131n etiketi bir d\u0131\u015f kab\u0131n etiketi olur.<\/span>\n\n<hr \/>\n\n<b><span>Gerekli Bilgilerin Belirtilmesi Formu<\/span><\/b>\n\n<span>FD&amp;C B\u00f6l\u00fcm 602(c), yasa veya d\u00fczenlemelerin gerektirdi\u011fi herhangi bir kelime, ifade veya di\u011fer etiket veya etiketleme bilgilerinin etiket veya etiket \u00fczerine okunmas\u0131 muhtemel belirgin ve dikkat \u00e7ekici bir \u015fekilde yerle\u015ftirilmemesi durumunda kozmetik \u00fcr\u00fcn\u00fcn\u00fcn yanl\u0131\u015f markalanm\u0131\u015f oldu\u011funu kabul eder. veya s\u0131radan bireylerin anlayabilece\u011fi \u015fekilde ifade edilmemi\u015fse.<\/span>\n\n<hr \/>\n\n<b><span>\u00d6ne \u00c7\u0131kma ve G\u00f6ze \u00c7arpma<\/span><a id=\"clge\" name=\"clge\"><\/a><\/b>\n<ul>\n \t<li><strong><span>Sat\u0131n alma s\u0131ras\u0131nda panel ekran\u0131<\/span><\/strong><\/li>\n \t<li><strong><span>Panel boyutu<\/span><\/strong><\/li>\n \t<li><strong><span>Harflerin stili ve boyutu<\/span><\/strong><\/li>\n \t<li><strong><span>Arka plan kontrast\u0131<\/span><\/strong><\/li>\n \t<li><strong><span>Gizleyici tasar\u0131mlar, k\u0131sa hikayeler<\/span><\/strong><\/li>\n<\/ul>\n<strong><span>21 CFR 701.2<\/span><\/strong>\n\n<span>FDA taraf\u0131ndan yay\u0131nlanan Y\u00f6netmelikler [21 CFR 701.2], bilgilerin kozmetik etiketler veya etiketler \u00fczerine belirgin ve dikkat \u00e7ekecek \u015fekilde yerle\u015ftirilmesi gereklili\u011fine nas\u0131l uyulaca\u011f\u0131 konusunda ayr\u0131nt\u0131l\u0131 bilgi sunar.<\/span>\n\n<strong><span>Panel ekran\u0131:<\/span><\/strong><span>\u00a0Gerekli bilgiler, al\u0131\u015f\u0131lagelmi\u015f sat\u0131n alma ko\u015fullar\u0131nda sunulan veya g\u00f6r\u00fcnt\u00fclenen bir panel \u00fczerinde bulunmal\u0131d\u0131r.\u00a0Bu, \u00e7ok k\u00fc\u00e7\u00fck olmad\u0131\u011f\u0131 ve olas\u0131 bir sat\u0131n alma i\u00e7in incelendi\u011finde geleneksel olarak elle al\u0131nmad\u0131\u011f\u0131 s\u00fcrece, gerekli bilgilerin bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn alt paneli \u00fczerine yerle\u015ftirilmesini ortadan kald\u0131r\u0131r.<\/span>\n\n<strong><span>Panel Boyutu:<\/span><\/strong><span>\u00a0Etiket, gerekli bilgilerin belirgin \u015fekilde g\u00f6r\u00fcnt\u00fclenmesi i\u00e7in yeterli alan sa\u011flayacak kadar b\u00fcy\u00fck olmal\u0131d\u0131r.<\/span>\n\n<strong><span>Harflerin Stili ve Boyutu:<\/span><\/strong><span>\u00a0Yaz\u0131 tipi, en az\u0131ndan gereken minimum boyutta ve gerekli etiket a\u00e7\u0131klamalar\u0131n\u0131n kolayca okunabilece\u011fi boyutta olmal\u0131d\u0131r.<\/span>\n\n<strong><span>Arka Plan Kontrast\u0131:<\/span><\/strong><span>\u00a0Kontrast, gerekli etiket a\u00e7\u0131klamalar\u0131n\u0131n dikkat \u00e7ekici ve kolay okunabilir olmas\u0131n\u0131 sa\u011flamak i\u00e7in yeterli olmal\u0131d\u0131r.<\/span>\n\n<strong><span>Anla\u015f\u0131lmaz Tasar\u0131mlar, K\u0131sa A\u00e7\u0131klamalar:<\/span><\/strong><span>\u00a0Gerekli ifadeler, k\u0131sa hikayeler veya di\u011fer tasar\u0131mlarla veya di\u011fer bas\u0131l\u0131 veya grafik materyallerle kalabal\u0131kla\u015ft\u0131r\u0131larak g\u00f6lgelenmemelidir.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" target=\"_blank\" rel=\"noopener\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Dil<\/span><a id=\"clgf\" name=\"clgf\"><\/a><\/b>\n<ul>\n \t<li><strong><span>\u0130ngilizce dil bildirimleri<\/span><\/strong><\/li>\n \t<li><strong><span>Yabanc\u0131 dil beyanlar\u0131<\/span><\/strong><\/li>\n<\/ul>\n<strong><span>21 CFR 701.2(b)<\/span><\/strong>\n\n<strong><span>\u0130ngilizce Dil Bildirimleri:<\/span><\/strong><span>\u00a0Yasa veya d\u00fczenlemelerin gerektirdi\u011fi t\u00fcm etiket veya etiketleme bildirimleri \u0130ngilizce dilinde olmal\u0131d\u0131r.\u00a0Yaln\u0131zca Porto Riko&#8217;da veya bask\u0131n dilin \u0130ngilizce d\u0131\u015f\u0131nda bir dil oldu\u011fu bir B\u00f6lgede da\u011f\u0131t\u0131lan \u00fcr\u00fcnler, gerekli etiket bilgilerini \u0130ngilizce yerine ge\u00e7erli dilde belirtebilir.<\/span>\n\n<strong><span>Yabanc\u0131 Dilde A\u00e7\u0131klamalar:<\/span><\/strong><span>\u00a0Etikette herhangi bir yabanc\u0131 dil ifadesi bulunuyorsa, mevzuat\u0131n gerektirdi\u011fi t\u00fcm ifadelerin etiket \u00fczerinde yabanc\u0131 dilde de yer almas\u0131 gerekir.\u00a0Etiketleme yabanc\u0131 dilde ifadeler ta\u015f\u0131yorsa, gerekli ifadeler etikette veya di\u011fer etiketlerde \u0130ngilizce olarak gerekti\u011fi \u015fekilde yer almal\u0131d\u0131r.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Tip Boyut<\/span><a id=\"clgg\" name=\"clgg\"><\/a><\/b>\n\n<strong><span>Malzemeler: 1\/16&#8243;, 1\/32&#8243; (Etiketleme y\u00fczeyi, 12 metrekareden az)<\/span><\/strong>\n\n<strong><span>Net \u0130\u00e7erik:<\/span><\/strong>\n<ul>\n \t<li><strong><span>1\/16&#8243; (PDP 5 metrekareden az)<\/span><\/strong><\/li>\n \t<li><strong><span>1\/8&#8243; (PDP 5-25 in\u00e7 kare)<\/span><\/strong><\/li>\n \t<li><strong><span>3\/16&#8243; (PDP 25-100 in\u00e7 kare)<\/span><\/strong>\n\n<strong><span>Uyar\u0131: 1\/16&#8243;<\/span><\/strong>\n\n<strong><span>Di\u011ferleri: Panel boyutuyla makul d\u00fczeyde ili\u015fkili<\/span><\/strong>\n\n<strong><span>21 CFR 701.2(a)(b), 701.3(b),<\/span>\n<span>701.11(c), 701.13(i), 740.2(b)<\/span><\/strong><\/li>\n<\/ul>\n<strong><span>\u0130\u00e7erik Beyan\u0131:<\/span><\/strong><span>\u00a0Genel olarak, y\u00fcksekli\u011fi 1\/16 in\u00e7ten az olmayan harflerle [21 CFR 701.3(b)]. Etiket ta\u015f\u0131yabilecek y\u00fczey alan\u0131 (dekoratif kabartmal\u0131 y\u00fczeyler, oymal\u0131 y\u00fczeyler hari\u00e7) 12 in\u00e7 kareden azsa, harf y\u00fckseklik 1\/32&#8243;den [21 CFR 701.3(p)] az olamaz.<\/span>\n\n<strong><span>KAP&#8217;ta Net \u0130\u00e7erik Beyan\u0131:<\/span><\/strong><span>\u00a0KAP&#8217;\u0131n\u00a0<\/span><strong><span>alan\u0131na<\/span><\/strong><span>\u00a0g\u00f6re belirlenen minimum harf y\u00fcksekli\u011fi .\u00a0Kartu\u015fun dekoratif kozmetik kaplar\u0131, hap kutusu, kompakt veya kalem tipi ve 1\/4 oz&#8217;luk kozmetikler dahil olmak \u00fczere &#8220;yatak odas\u0131 tipi&#8221; kaplar durumunda.\u00a0veya daha az kapasiteli ise tip boyutu konteynerin toplam boyutlar\u0131na g\u00f6re belirlenir.\u00a0Kab\u0131n bir ekran kart\u0131na monte edilmesi durumunda, ekran paneli harf y\u00fcksekli\u011fini [21 CFR 701.13(e) ve (i)] belirler.<\/span>\n\n<strong><span>Uyar\u0131 A\u00e7\u0131klamalar\u0131:<\/span><\/strong><span>\u00a0D\u00fczenleme [21 CFR 740.2] taraf\u0131ndan daha k\u00fc\u00e7\u00fck bir boyut belirlenmedi\u011fi s\u00fcrece, tip boyutu 1\/16 in\u00e7ten az olmamal\u0131d\u0131r.<\/span>\n\n<strong><span>Harf Y\u00fcksekli\u011fi:<\/span><\/strong><span>\u00a0K\u00fc\u00e7\u00fck harf &#8220;o&#8221; veya b\u00fcy\u00fck ve k\u00fc\u00e7\u00fck harfler kullan\u0131ld\u0131\u011f\u0131nda e\u015fde\u011feri [21 CFR 701.13(h)].<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Kimlik Etiketleme<\/span><a id=\"clgh\" name=\"clgh\"><\/a><\/b>\n<ul>\n \t<li><strong><span>Ortak veya ola\u011fan ad<\/span><\/strong><\/li>\n \t<li><strong><span>A\u00e7\u0131klay\u0131c\u0131 ad<\/span><\/strong><\/li>\n \t<li><strong><span>Hayali isim<\/span><\/strong><\/li>\n \t<li><strong><span>\u0130ll\u00fcstrasyon<\/span><\/strong><\/li>\n \t<li><strong><span>\u00d6nem<\/span><\/strong><\/li>\n \t<li><strong><span>Atama<\/span><\/strong><\/li>\n<\/ul>\n<strong><span>saniye.\u00a010(t), FP&amp;L Yasas\u0131<\/span>\n<span>21 CFR 701.11<\/span><\/strong>\n\n<span>saniye.\u00a0FP&amp;L Yasas\u0131&#8217;n\u0131n [21 USC 14554] 4&#8217;\u00fc, bir t\u00fcketici \u00fcr\u00fcn\u00fcn\u00fcn bir kimlik beyan\u0131 ta\u015f\u0131mas\u0131n\u0131 gerektirir.\u00a0FDA taraf\u0131ndan yay\u0131nlanan d\u00fczenlemeler [21 CFR 701.11], kimlik beyan\u0131n\u0131n PDP&#8217;de g\u00f6r\u00fcnmesini gerektirir.<\/span>\n\n<span>Mal\u0131n kimli\u011fi, kozmetik \u00fcr\u00fcn\u00fcn\u00fcn ortak veya mutat ad\u0131, tan\u0131mlay\u0131c\u0131 bir ad veya kozmeti\u011fin do\u011fas\u0131 belli oldu\u011funda hayali bir adla ifade edilebilir.\u00a0Bir ill\u00fcstrasyon \u015feklinde de ifade edilebilir.<\/span>\n\n<span>Kimlik beyan\u0131 kal\u0131n harflerle yaz\u0131lmal\u0131 ve en belirgin bas\u0131l\u0131 materyalle (genellikle kozmetik \u00fcr\u00fcn\u00fcn\u00fcn ad\u0131) makul \u00f6l\u00e7\u00fcde ilgili bir boyutta olmal\u0131d\u0131r.\u00a0Perakende sat\u0131\u015fta sergilendi\u011finde \u00fcr\u00fcn\u00fcn dayand\u0131\u011f\u0131 tabana genellikle paralel \u00e7izgilerde olmal\u0131d\u0131r.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Ad\u0131 ve \u0130\u015f Yeri<\/span><a id=\"clgi\" name=\"clgi\"><\/a><\/b>\n\n<strong><span>\u015eirket ad\u0131<\/span>\n<span>\u00dcretildi\u011fi&#8230;<\/span>\n<span>Da\u011f\u0131tt\u0131\u011f\u0131&#8230;<\/span>\n<span>Adres<\/span>\n<span>Ana i\u015f yeri<\/span><\/strong>\n\n<strong><span>21 CFR 701.12<\/span><\/strong>\n\n<span>Etikette g\u00f6r\u00fcnen isim ve i\u015f adresi \u00fcreticinin, paketleyicinin veya distrib\u00fct\u00f6r\u00fcn olabilir.<\/span>\n\n<span>\u0130sim ve adres \u00fcreticinin ad\u0131 de\u011filse, ismin \u00f6n\u00fcne &#8220;\u00dcretici i\u00e7in \u00fcretilmi\u015ftir&#8230;&#8221;, &#8220;Da\u011f\u0131t\u0131c\u0131s\u0131&#8230;&#8221; gibi ifadeler veya ba\u015fka uygun ifadeler gelmelidir.<\/span>\n\n<span>Firman\u0131n ad\u0131 \u015firket ad\u0131 olmal\u0131 ve adres, i\u015f merkezinin adresi olabilir.\u00a0Ayr\u0131ca bir \u015firketin belirli b\u00f6l\u00fcm\u00fcn\u00fcn ad\u0131n\u0131n belirtilmesi iste\u011fe ba\u011fl\u0131d\u0131r.<\/span>\n\n<span>\u0130\u015fletme adresi sokak adresini, \u015fehrin ve eyaletin ad\u0131n\u0131 ve posta kodunu i\u00e7ermelidir.\u00a0Firman\u0131n ge\u00e7erli bir \u015fehir veya telefon rehberinde listelenmesi durumunda sokak adresi atlanabilir.<\/span>\n\n<span>1930 tarihli Tarife Yasas\u0131, ithal edilen \u00fcr\u00fcnlerin etiketinde men\u015fei \u00fclkenin \u0130ngilizce ad\u0131n\u0131n belirtilmesini gerektirmektedir.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>\u0130\u00e7erik Miktar\u0131<\/span><a id=\"clgj\" name=\"clgj\"><\/a><\/b>\n\n<strong><span>Paket \u00dczerindeki Yer \u00a7 701.13 (e) ve (f)(2)<\/span>\n<span>KAP&#8217;ta<\/span>\n<span>Bilgi panelinde<\/span><\/strong>\n\n<strong><span>\u00d6nem \u00a7 701.13 (f) ve (f)(1)<\/span>\n<span>Yerle\u015ftirme<\/span>\n<span>Aral\u0131\u011f\u0131<\/span><\/strong>\n\n<strong><span>G\u00f6ze \u00c7arpanl\u0131k \u00a7 701.13 (h) ve (i)<\/span>\n<span>S\u00f6zle\u015fme<\/span>\n<span>Harf Y\u00fcksekli\u011fi<\/span>\n<span>En Boy Oran\u0131<\/span>\n<span>Tip Boyutu<\/span><\/strong>\n\n<strong><span>Yer<\/span><\/strong><span>\u00a0: Kozmetik perakende olarak bir d\u0131\u015f kapta sat\u0131l\u0131yorsa, net i\u00e7erik beyan\u0131 (1) d\u0131\u015f kab\u0131n PDP&#8217;sinin alt %30&#8217;luk k\u0131sm\u0131nda, genellikle paketin dayand\u0131\u011f\u0131 tabana paralel olarak g\u00f6r\u00fcnmelidir ve (2) i\u00e7 kab\u0131n bilgi panelinde.\u00a05 in\u00e7 kare veya daha k\u00fc\u00e7\u00fck PDP&#8217;ler i\u00e7in alt konum gereksiniminden feragat edilir.<\/span>\n\n<span>PDP, dekoratif bir kaba veya 1\/4 oz&#8217;dan daha k\u00fc\u00e7\u00fck bir kaba yap\u0131\u015ft\u0131r\u0131lan y\u0131rt\u0131labilir bir etiket veya bant olabilir veya kab\u0131n yap\u0131\u015ft\u0131r\u0131ld\u0131\u011f\u0131 bir ekran kart\u0131n\u0131n paneli olabilir.<\/span>\n\n<strong><span>\u00d6ne \u00c7\u0131kma<\/span><\/strong><span>\u00a0: Beyanname, di\u011fer bas\u0131l\u0131 materyallerden en az beyanda kullan\u0131lan harf y\u00fcksekli\u011finde ve &#8220;N&#8221; harfinin geni\u015fli\u011finin iki kat\u0131 kadar bo\u015flukla ayr\u0131lm\u0131\u015f ayr\u0131 bir \u00f6\u011fe olmal\u0131d\u0131r.<\/span>\n\n<strong><span>Dikkat \u00c7ekicilik<\/span><\/strong><span>\u00a0: Bask\u0131, ambalaj\u0131n \u00fczerindeki arka plan ve di\u011fer hususlara uygun olarak, kolayca okunabilir, kal\u0131n yaz\u0131 tipinde olmal\u0131d\u0131r.\u00a0Harf y\u00fcksekli\u011fi en az k\u00fc\u00e7\u00fck harf &#8220;o&#8221; kadar olmal\u0131 ve y\u00fcksekli\u011fin geni\u015fli\u011fe oran\u0131 3:1&#8217;i ge\u00e7memelidir.<\/span>\n\n<strong><span>PDP alan\u0131na<\/span><\/strong><span>\u00a0g\u00f6re belirlenen tip boyutu,\u00a0PDP alan\u0131 5 in\u00e7 kare ise en az 1\/16 in\u00e7, PDP alan\u0131 &gt; 5 ila 25 in\u00e7 kare ise 1\/8 in\u00e7, 3\/16 olmal\u0131d\u0131r PDP alan\u0131 &gt; 25 ila 100 in\u00e7 kare ise in\u00e7 ve PDP alan\u0131 &gt; 100 in\u00e7 kare ise 1\/4 in\u00e7<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Net \u0130\u00e7erik Beyan\u0131ndan Muafiyetler<\/span><\/b>\n\n<strong><span>Av.&#8217;nin 1\/4&#8217;\u00fcnden az olan kozmetikler.\u00a0oz.\u00a0veya 1\/8 fl.\u00a0oz.<\/span><\/strong>\n<ul>\n \t<li><strong><span>Ekran kart\u0131nda<\/span><\/strong><\/li>\n \t<li><strong><span>D\u0131\u015f kapta<\/span><\/strong><\/li>\n<\/ul>\n<strong><span>21 CFR 1,24<\/span><\/strong>\n\n<span>Av.&#8217;nin 1\/4&#8217;\u00fcnden az\u0131n\u0131 i\u00e7eren ambalajlardaki kozmetikler.\u00a0oz.\u00a0veya 1\/8 fl.\u00a0oz.\u00a0uygun \u015fekilde etiketlenmi\u015f bir ekran kart\u0131na yap\u0131\u015ft\u0131r\u0131lmas\u0131 veya perakende olarak uygun \u015fekilde etiketlenmi\u015f bir d\u0131\u015f kapta sat\u0131lmas\u0131 durumunda net i\u00e7erik miktar\u0131 beyan\u0131ndan muaft\u0131r [21 CFR 1.24].<\/span>\n\n<span>Bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn i\u00e7 ve d\u0131\u015f ambalaj\u0131nda \u200b\u200bnet i\u00e7erik miktar\u0131 beyan\u0131 ta\u015f\u0131mas\u0131 gerekiyorsa, d\u0131\u015f ambalajdaki beyan\u0131n PDP&#8217;de g\u00f6r\u00fcnmesi gerekir;\u00a0i\u00e7 kapta \u00fcr\u00fcn\u00fcn ad\u0131n\u0131 ta\u015f\u0131yan panel yani \u00f6n panel d\u0131\u015f\u0131nda bir bilgi panelinde de yer alabilir.<\/span>\n\n<hr \/>\n\n<b><span>\u0130\u00e7erik Miktar\u0131<\/span><\/b>\n\n<strong><span>Do\u011fruluk\u00a0<\/span><span>\u00a7 701.13 (g) ve (s)<\/span><\/strong>\n\n<strong><span>\u00dcr\u00fcn Tutarl\u0131l\u0131\u011f\u0131 Beyan\u0131\u00a0<\/span><span>\u00a7 701.13 (a)<\/span><\/strong>\n\n<strong><span>\u00d6l\u00e7\u00fc ve A\u011f\u0131rl\u0131k Sistemleri\u00a0<\/span><span>\u00a7 701.13(b) ve (r)<\/span><\/strong>\n\n<strong><span>Birim Terimleri ve K\u0131saltmalar\u00a0<\/span><span>\u00a7 701.13 (j) (2) &amp; (n)<\/span><\/strong>\n\n<strong><span>\u0130kili Beyan Formu\u00a0<\/span><span>701.13 (j) (1)<\/span><\/strong>\n\n<strong><span>Kesir Beyan\u0131\u00a0<\/span><span>\u00a7 701.13 (d)<\/span><\/strong>\n\n<hr \/>\n\n<b><span>Net Miktar Tablosu \u00d6rnekleri<\/span><\/b>\n\n<strong><span>&#8220;Net A\u011f\u0131rl\u0131k 6 Oz.&#8221;\u00a0veya &#8220;6 oz. Net A\u011f\u0131rl\u0131k.&#8221;<\/span>\n<span>&#8220;Net \u0130\u00e7erik 6 fl. Oz.&#8221;\u00a0veya &#8220;Net 6 FL. Oz.&#8221;\u00a0veya &#8220;6 fl. Oz.&#8221;<\/span>\n<span>&#8220;Net A\u011f\u0131rl\u0131k 1\/4 Oz.&#8221;\u00a0veya &#8220;Net A\u011f\u0131rl\u0131k 0,25 Oz.&#8221;<\/span>\n<span>&#8220;Net 1\/8 fl. Oz.&#8221;\u00a0veya &#8220;0,12 FL. Oz.&#8221;<\/span>\n<span>&#8220;Net A\u011f\u0131rl\u0131k 24 Oz. (1-1\/2 Lb.)&#8221; veya &#8220;Net A\u011f\u0131rl\u0131k 24 Oz. (1,5 Lb.)&#8221;<\/span>\n<span>&#8220;Net 56 Fl. Oz. (1 Qt. 1 Pt. 8 Fl. Oz.) )&#8221; veya &#8220;&#8230; (1 Adet 1-1\/2 Pt.)&#8221; veya &#8220;&#8230; (1 Adet 1,5 Pt.)&#8221;<\/span><\/strong>\n\n<strong><span>Do\u011fruluk:<\/span><\/strong><span>\u00a0Net i\u00e7erik miktar\u0131 (net i\u00e7erik) beyan\u0131, kaptaki kozmetik miktar\u0131n\u0131 a\u011f\u0131rl\u0131k, hacim, \u00f6l\u00e7\u00fc, say\u0131sal say\u0131m veya say\u0131 ve a\u011f\u0131rl\u0131k, hacim veya \u00f6l\u00e7\u00fc kombinasyonlar\u0131 a\u00e7\u0131s\u0131ndan do\u011fru bir \u015fekilde ortaya koymal\u0131d\u0131r.\u00a0Nem kayb\u0131 veya kazanc\u0131ndan veya iyi \u00fcretim uygulamalar\u0131ndaki sapmalardan kaynaklanan makul de\u011fi\u015fiklikler kabul edilebilir.\u00a0Aerosol \u00fcr\u00fcn s\u00f6z konusu oldu\u011funda net i\u00e7erik beyan\u0131, d\u0131\u015far\u0131 at\u0131lan i\u00e7eri\u011fin net miktar\u0131n\u0131 ifade etmelidir.<\/span>\n\n<strong><span>\u00dcr\u00fcn Tutarl\u0131l\u0131\u011f\u0131:<\/span><\/strong><span>\u00a0Aksine kesin olarak yerle\u015fmi\u015f, genel bir t\u00fcketici kullan\u0131m\u0131 veya ticari gelenek olmad\u0131\u011f\u0131 s\u00fcrece, beyan, kozmetik s\u0131v\u0131 ise s\u0131v\u0131 \u00f6l\u00e7\u00fcs\u00fc, kozmetik kat\u0131, yar\u0131 kat\u0131, viskoz ise a\u011f\u0131rl\u0131k cinsinden olmal\u0131d\u0131r. veya kat\u0131 ve s\u0131v\u0131 kar\u0131\u015f\u0131m\u0131.\u00a0S\u0131v\u0131 \u00f6l\u00e7\u00fcleri 20\u00b0C&#8217;deki (68\u00b0F) hacmi ifade etmelidir.\u00a0Aerosol \u00fcr\u00fcnler i\u00e7in geleneksel net i\u00e7erik beyan\u0131 a\u011f\u0131rl\u0131k cinsindendir.<\/span>\n\n<strong><span>Sistemler:<\/span><\/strong><span>\u00a0A\u011f\u0131rl\u0131k, avoirdupois pound ve ons cinsinden ifade edilir.\u00a0S\u0131v\u0131 \u00f6l\u00e7\u00fcmleri ABD galonu, litre, pint ve s\u0131v\u0131 onsu cinsinden ifade edilir.\u00a0Net i\u00e7erik ayr\u0131ca metrik sistemde de belirtilebilir.<\/span>\n\n<strong><span>Birim Terimleri:<\/span><\/strong><span>\u00a0&#8220;Net a\u011f\u0131rl\u0131k&#8221; veya &#8220;net a\u011f\u0131rl\u0131k&#8221; terimi.\u00a0a\u011f\u0131rl\u0131k beyan\u0131yla birlikte kullan\u0131lmal\u0131 ve s\u0131v\u0131 beyan\u0131yla ba\u011flant\u0131l\u0131 olarak &#8220;net i\u00e7erik&#8221;, &#8220;net&#8221; veya hi\u00e7bir \u015fey terimi kullan\u0131lmamal\u0131d\u0131r.<\/span>\n\n<span>Ek k\u0131saltmalar \u015funlard\u0131r: a\u011f\u0131rl\u0131k &#8211; a\u011f\u0131rl\u0131k, s\u0131v\u0131 &#8211; fl., galon &#8211; gal., quart &#8211; qt., pint &#8211; pt., ons &#8211; oz., pound &#8211; lb.<\/span>\n\n<span>A\u011f\u0131rl\u0131k ons \u200b\u200bifadesi durumunda &#8220;oz.&#8221; terimi kullan\u0131l\u0131r.\u00a0yeterlidir.\u00a0S\u0131v\u0131 ons &#8220;fl. oz&#8221; olarak ifade edilir.<\/span>\n\n<span>\u00d6rnekler:<\/span>\n<ul>\n \t<li><span>Net a\u011f\u0131rl\u0131k\u00a04 av.\u00a0oz.<\/span><\/li>\n \t<li><span>Net i\u00e7erik 4 fl.\u00a0oz.<\/span><\/li>\n \t<li><span>4 av.\u00a0oz.\u00a0net a\u011f\u0131rl\u0131k<\/span><\/li>\n \t<li><span>115 gram.\u00a0net a\u011f\u0131rl\u0131k<\/span><\/li>\n \t<li><span>Net 4 fl.\u00a0oz.<\/span><\/li>\n \t<li><span>4 fl.\u00a0oz.<\/span><\/li>\n<\/ul>\n<strong><span>\u0130kili Beyan:<\/span><\/strong><span>\u00a0Net a\u011f\u0131rl\u0131\u011f\u0131n bir pound&#8217;u a\u015fmas\u0131 ancak 4 pound&#8217;dan az olmas\u0131 durumunda, net i\u00e7erik beyan\u0131nda toplam ons say\u0131s\u0131n\u0131 parantez i\u00e7inde pound ve ons say\u0131s\u0131 veya pound say\u0131s\u0131 ve kesirleri ile birlikte belirtilmelidir.\u00a0Bir pinti a\u015fan ancak bir galondan az olan s\u0131v\u0131 \u00f6l\u00e7\u00fcmleri, parantez i\u00e7inde, litre, pint ve ons say\u0131s\u0131 veya litre veya pintin kesirleri ile takip edilen toplam s\u0131v\u0131 ons say\u0131s\u0131 cinsinden ifade edilmelidir.<\/span>\n\n<span>\u00d6rnekler:<\/span>\n<ul>\n \t<li><span>Net A\u011f\u0131rl\u0131k\u00a024 oz.\u00a0(1 lb. 8 oz.)<\/span><\/li>\n \t<li><span>Net A\u011f\u0131rl\u0131k\u00a024 oz.\u00a0(1 &#8211; 1\/2 lb.)<\/span><\/li>\n \t<li><span>Net A\u011f\u0131rl\u0131k\u00a024 oz.\u00a0(1,5 lb.)<\/span><\/li>\n \t<li><span>56 fl.\u00a0oz.\u00a0(1 qt. 1 pt. 8 fl. oz.)<\/span><\/li>\n \t<li><span>56 fl.\u00a0oz.\u00a0(1 qt. 1-1\/2 pt.)<\/span><\/li>\n \t<li><span>56 fl.\u00a0oz.\u00a0(1 qt. 1,5 pt.)<\/span><\/li>\n \t<li><span>56 fl.\u00a0oz.\u00a0(1-3\/4 qt.)<\/span><\/li>\n<\/ul>\n<span>Kesirlerin beyan\u0131: Kesirler, 1\/2 ila 1\/32 aras\u0131nda de\u011fi\u015fen ortak kesirler cinsinden veya ikiden fazla anlaml\u0131 say\u0131n\u0131n ondal\u0131k kesirleri olarak ifade edilebilir.<\/span>\n\n<hr \/>\n\n<b><span>\u0130\u00e7erik Miktar\u0131<\/span><\/b>\n\n<strong><span>Ana Ekran Panelinde<\/span><\/strong>\n\n<strong><span>&#8220;Ekonomi Boyutu&#8221; veya &#8220;B\u00fct\u00e7e Boyutu&#8221;<\/span>\n<span>&#8220;Giant Pint&#8221; veya &#8220;Tam Quart&#8221;<\/span>\n<span>&#8220;Net 6 Fl. Oz.&#8221;\u00a0ve &#8220;Alt\u0131 Uygulama&#8221;<\/span>\n<span>&#8220;Net 6 FL. Oz.&#8221;\u00a0ve &#8220;Her biri 1 fl. Oz&#8217;luk 6 \u015ei\u015fe&#8221;<\/span><\/strong>\n\n<strong><span>Bilgi Panelinde<\/span><\/strong>\n\n<strong><span>Yan\u0131lt\u0131c\u0131 olmayan herhangi bir ek beyan<\/span><\/strong>\n\n<strong><span>21 CFR 1.31 ve 701.13 (g)<\/span><\/strong>\n\n<strong><span>Ekonomi Boyutu:<\/span><\/strong><span>\u00a0Firman\u0131n ayn\u0131 markan\u0131n en az bir ba\u015fka ambalaj boyutunu sunmas\u0131, yaln\u0131zca birinin &#8220;ekonomik boyut&#8221; olarak etiketlenmesi ve bu \u015fekilde etiketlenen paketin birim fiyat\u0131n\u0131n \u00f6nemli \u00f6l\u00e7\u00fcde (en az %5) olmas\u0131 durumunda bu t\u00fcr temsillere izin verilir. di\u011fer pakete g\u00f6re azalt\u0131lm\u0131\u015ft\u0131r.<\/span>\n\n<strong><span>Dev Bira Barda\u011f\u0131, Tam Quart:<\/span><\/strong><span>\u00a0\u0130\u00e7eri\u011fin net miktar\u0131n\u0131 a\u00e7\u0131klayan ek ifadelere PDP d\u0131\u015f\u0131ndaki panellerde izin verilir.\u00a0Ancak bu ifadelerin aldat\u0131c\u0131 olmamas\u0131 veya pakette bulunan miktar\u0131 abartmamas\u0131 gerekir.<\/span>\n\n<strong><span>Alt\u0131 Uygulama:<\/span><\/strong><span>\u00a0Say\u0131sal say\u0131m veya do\u011frusal veya alan \u00f6l\u00e7\u00fcm\u00fcyle yap\u0131lan bildirimler, do\u011fru bilgi vermek i\u00e7in a\u011f\u0131rl\u0131k veya bireysel birimlerin boyutu veya toplam a\u011f\u0131rl\u0131k veya \u00f6l\u00e7\u00fc ifadeleriyle geni\u015fletilebilir.\u00a0Bunlar ayr\u0131 beyanlar olarak kabul edilmez ve KAP&#8217;ta yer almalar\u0131 gerekir.<\/span>\n\n<strong><span>Kozmetik Kit:<\/span><\/strong><span>\u00a0Bir ambalaj, bir kiti olu\u015fturan entegre bile\u015fenleri i\u00e7eriyorsa ve bile\u015fenleri, \u00f6rne\u011fin evde kal\u0131c\u0131 bir dalga kiti gibi bir uygulama \u015feklinde teslim ediyorsa, net i\u00e7erik beyan\u0131, uygulama say\u0131s\u0131 cinsinden \u015fu \u015fekilde ifade edilebilir: verilen talimatlara g\u00f6re [21 CFR 701.13 (g) (2)].<\/span>\n\n<hr \/>\n\n<b><span>Kozmetik Uyar\u0131 \u0130fadeleri<\/span><a id=\"clgk\" name=\"clgk\"><\/a><\/b>\n\n<strong><span>Genel Gereksinim:<\/span>\n<span>\u00d6ne \u00c7\u0131kma<\/span><\/strong>\n<ul>\n \t<li><span>Atama<\/span><\/li>\n \t<li><span>Aral\u0131k<\/span><\/li>\n<\/ul>\n<strong><span>dikkat \u00e7ekicilik<\/span><\/strong>\n<ul>\n \t<li><span>Z\u0131tl\u0131k<\/span><\/li>\n \t<li><span>Tip boyutu<\/span><\/li>\n<\/ul>\n<strong><span>21 CFR 740 (1) ve (2)<\/span><\/strong>\n\n<span>D\u00fczenlemeler, &#8220;[bir kozmetik \u00fcr\u00fcn\u00fcn etiketinde, \u00fcr\u00fcnle ili\u015fkili olabilecek bir sa\u011fl\u0131k tehlikesini \u00f6nlemek i\u00e7in gerekli veya uygun oldu\u011funda bir uyar\u0131 ifadesi bulunmal\u0131d\u0131r&#8221; [21 CFR 740(1)] gerektirmektedir.\u00a0Gerekli bir uyar\u0131 ifadesini ta\u015f\u0131mayan bir kozmetik madde, b\u00f6l\u00fcm 2&#8217;ye g\u00f6re yanl\u0131\u015f markalanm\u0131\u015f olarak kabul edilebilir.\u00a0FD&amp;C Yasas\u0131&#8217;n\u0131n 602(a) maddesi, \u00e7\u00fcnk\u00fc &#8220;makalenin kullan\u0131m\u0131ndan kaynaklanabilecek sonu\u00e7larla ilgili &#8230; \u00f6nemli&#8221; bir ger\u00e7e\u011fi ortaya koyam\u0131yor [sek 201(n), FD&amp;C Yasas\u0131].<\/span>\n\n<strong><span>\u00d6ne \u00c7\u0131kma<\/span><\/strong><span>\u00a0: Bir uyar\u0131 ifadesi, sat\u0131n alma ve kullan\u0131m s\u0131ras\u0131nda s\u0131radan t\u00fcketiciler taraf\u0131ndan okunabilmesi i\u00e7in, di\u011fer kelimelere, ifadelere veya tasar\u0131mlara k\u0131yasla etiket \u00fczerinde belirgin ve dikkat \u00e7ekici bir \u015fekilde yer almal\u0131d\u0131r.<\/span>\n\n<strong><span>Dikkat \u00c7ekicilik<\/span><\/strong><span>\u00a0: Yaz\u0131lar kontrastl\u0131 bir arka plan \u00fczerinde kal\u0131n harflerle yaz\u0131lmal\u0131 ve hi\u00e7bir durumda y\u00fcksekli\u011fi 1\/16 in\u00e7ten az olmamal\u0131d\u0131r.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>G\u00fcvenli\u011fi Kan\u0131tlanmam\u0131\u015f Kozmetikler<\/span><\/b>\n\n<strong><em><span>Uyar\u0131<\/span><\/em><span>\u00a0&#8211;Bu \u00fcr\u00fcn\u00fcn g\u00fcvenli\u011fi belirlenmemi\u015ftir.<\/span><\/strong>\n\n<strong><span>21 CFR 740.10<\/span><\/strong>\n\n<span>Bir kozmetik, g\u00fcvenli\u011fi yeterince kan\u0131tlanmam\u0131\u015fsa ve PDP&#8217;de a\u015fa\u011f\u0131daki dikkat \u00e7ekici ifadeyi ta\u015f\u0131m\u0131yorsa, yanl\u0131\u015f markalanm\u0131\u015f olarak kabul edilir:<\/span>\n\n<span>Uyar\u0131 &#8211; Bu \u00fcr\u00fcn\u00fcn g\u00fcvenli\u011fi belirlenmemi\u015ftir.<\/span>\n\n<span>Bilimsel e\u011fitim ve deneyime sahip uzmanlar, mevcut toksikolojik ve di\u011fer test verileri, kimyasal bile\u015fim ve di\u011fer ilgili bilgilerden \u00fcr\u00fcn\u00fcn al\u0131\u015f\u0131lagelmi\u015f kullan\u0131m ko\u015fullar\u0131 alt\u0131nda t\u00fcketicilere zarar vermedi\u011fi sonucuna varabilirse, bir kozmetik \u00fcr\u00fcn\u00fcn g\u00fcvenli\u011finin yeterince kan\u0131tland\u0131\u011f\u0131 kabul edilebilir. ve makul olarak \u00f6ng\u00f6r\u00fclebilir yanl\u0131\u015f kullan\u0131m ko\u015fullar\u0131.<\/span>\n\n<span>Bir kozmetik \u00fcr\u00fcn\u00fcn g\u00fcvenli\u011fi a\u015fa\u011f\u0131dakilerle yeterince kan\u0131tlanabilir:<\/span>\n\n<span>A.\u00a0\u0130\u00e7eri\u011findeki maddelere ve benzer \u00fcr\u00fcnlere ili\u015fkin mevcut toksikolojik test verilerine g\u00fcvenme ve<\/span>\n\n<span>B.\u00a0Mevcut veriler \u0131\u015f\u0131\u011f\u0131nda uygun ilave toksikolojik ve di\u011fer testlerin yap\u0131lmas\u0131.<\/span>\n\n<span>Her bir bile\u015fenin g\u00fcvenli\u011fi kan\u0131tlanm\u0131\u015f olsa bile, genellikle yeterli g\u00fcvenlik kan\u0131t\u0131n\u0131 sa\u011flamak i\u00e7in form\u00fcle edilmi\u015f \u00fcr\u00fcnde en az\u0131ndan baz\u0131 toksikolojik testlerin yap\u0131lmas\u0131 gerekir.<\/span>\n\n<hr \/>\n\n<b><span>Kozmetik Aerosoller<\/span><\/b>\n\n<strong><em><span>Uyar\u0131<\/span><\/em><span>\u00a0&#8211;G\u00f6zlere p\u00fcsk\u00fcrtmekten ka\u00e7\u0131n\u0131n.\u00a0Bask\u0131 alt\u0131ndaki i\u00e7erik.\u00a0Delmeyin veya yakmay\u0131n.\u00a0120\u00b0F&#8217;\u0131n \u00fczerindeki s\u0131cakl\u0131klarda saklamay\u0131n.\u00a0\u00c7ocuklar\u0131n eri\u015femeyece\u011fi yerlerde saklay\u0131n.<\/span><\/strong>\n\n<strong><span>21 CFR 740.11(a)<\/span><\/strong>\n\n<span>Kendinden bas\u0131n\u00e7land\u0131r\u0131lm\u0131\u015f kapta ambalajlanan ve ambalajdan bas\u0131n\u00e7 alt\u0131nda at\u0131lmas\u0131 ama\u00e7lanan kozmetik \u00fcr\u00fcn\u00fcn etiketinde a\u015fa\u011f\u0131da belirtilen uyar\u0131n\u0131n bulunmas\u0131 gerekmektedir.<\/span>\n\n<span>E\u011fer \u00fcr\u00fcn sprey olarak at\u0131lm\u0131yorsa &#8220;G\u00f6zlere p\u00fcsk\u00fcrtmekten ka\u00e7\u0131n\u0131n&#8221; ibaresi atlanabilir.\u00a0\u00d6rnek: Aerosol t\u0131ra\u015f kremi.<\/span>\n\n<span>\u00dcr\u00fcn cam kapta paketleniyorsa &#8220;delinme&#8221; kelimesi &#8220;k\u0131r\u0131lma&#8221; kelimesiyle de\u011fi\u015ftirilebilir.<\/span>\n\n<span>\u00dcr\u00fcn\u00fcn \u00e7ocuklar taraf\u0131ndan kullan\u0131lmas\u0131 ama\u00e7lan\u0131yorsa uyar\u0131n\u0131n son c\u00fcmlesinin sonuna &#8220;yeti\u015fkin g\u00f6zetimi d\u0131\u015f\u0131nda&#8221; ibaresi eklenebilir.<\/span>\n\n<hr \/>\n\n<b><span>Kozmetik Aerosoller<\/span><\/b>\n\n<strong><em><span>Uyar\u0131<\/span><\/em><span>\u00a0&#8211;Yaln\u0131zca belirtildi\u011fi \u015fekilde kullan\u0131n.\u00a0\u0130\u00e7eri\u011fin kas\u0131tl\u0131 olarak konsantre edilmesi ve solunmas\u0131 yoluyla yap\u0131lan kas\u0131tl\u0131 yanl\u0131\u015f uygulamalar zararl\u0131 veya \u00f6l\u00fcmc\u00fcl olabilir.<\/span><\/strong>\n\n<strong><span>21 CFR 740.11(b)<\/span><\/strong>\n\n<span>Kendinden bas\u0131n\u00e7land\u0131r\u0131lm\u0131\u015f bir kapta ambalajlanan bir kozmetik \u00fcr\u00fcn\u00fcn itici gaz\u0131n\u0131n tamam\u0131 veya bir k\u0131sm\u0131 halokarbon veya hidrokarbondan olu\u015fuyorsa, etikette a\u015fa\u011f\u0131da belirtildi\u011fi gibi ikinci bir uyar\u0131 bulunmal\u0131d\u0131r.<\/span>\n\n<span>Bu ikinci uyar\u0131 a\u015fa\u011f\u0131daki \u00fcr\u00fcnler i\u00e7in gerekli de\u011fildir:<\/span>\n\n<span>1. %10&#8217;dan az itici gaz i\u00e7eren aerosol k\u00f6p\u00fck veya krem \u200b\u200b\u00fcr\u00fcnleri.<\/span>\n\n<span>2.Kullan\u0131m s\u0131ras\u0131nda itici gaz\u0131 d\u0131\u015far\u0131 atmayan \u00fcr\u00fcnler.\u00a0\u00d6rnekler: yerle\u015fik piston bariyerli veya itici gaz torbal\u0131 \u00fcr\u00fcnler.<\/span>\n\n<span>3. 2 oz&#8217;tan k\u00fc\u00e7\u00fck \u00f6l\u00e7\u00fcl\u00fc sprey \u00fcr\u00fcnleri.\u00a0net i\u00e7erikleri.<\/span>\n\n<span>4. 1\/2 oz&#8217;dan az aerosol \u00fcr\u00fcnleri.\u00a0net i\u00e7erikleri.<\/span>\n\n<hr \/>\n\n<b><span>Kad\u0131ns\u0131 Deodorant Spreyleri<\/span><\/b>\n\n<strong><em><span>Dikkat<\/span><\/em><span>\u00a0&#8211;Yaln\u0131zca harici kullan\u0131m i\u00e7indir.\u00a0Ciltten en az 8 in\u00e7 uza\u011fa p\u00fcsk\u00fcrt\u00fcn.\u00a0K\u0131r\u0131k, tahri\u015f olmu\u015f veya ka\u015f\u0131nan cilde uygulamay\u0131n.\u00a0Kal\u0131c\u0131, ola\u011fand\u0131\u015f\u0131 koku veya ak\u0131nt\u0131, doktora ba\u015fvurulmas\u0131 gereken durumlar\u0131n g\u00f6stergesi olabilir.\u00a0K\u0131zar\u0131kl\u0131k, tahri\u015f veya rahats\u0131zl\u0131k geli\u015firse kullanmay\u0131 hemen b\u0131rak\u0131n.<\/span><\/strong>\n\n<strong><span>21 CFR 740.12<\/span><\/strong>\n\n<span>Bu d\u00fczenlemenin amac\u0131na uygun olarak &#8220;etiketi, \u00fcr\u00fcn\u00fcn kad\u0131n genital b\u00f6lgesinde veya t\u00fcm v\u00fccutta kullan\u0131ma y\u00f6nelik oldu\u011funu g\u00f6steren veya ima eden herhangi bir sprey deodorant \u00fcr\u00fcn\u00fc&#8221; olarak tan\u0131mlanan kad\u0131n deodorant spreyi, belirtilen uyar\u0131y\u0131 ta\u015f\u0131mal\u0131d\u0131r. alt\u0131nda.<\/span>\n\n<span>\u0130hra\u00e7 edilen \u00fcr\u00fcn\u00fcn s\u0131v\u0131la\u015ft\u0131r\u0131lm\u0131\u015f halokarbon veya hidrokarbon itici gaz i\u00e7ermemesi durumunda, &#8220;Deriden en az 8 in\u00e7 uzakta p\u00fcsk\u00fcrt\u00fcn&#8221; c\u00fcmlesi \u00e7\u0131kart\u0131labilir.<\/span>\n\n<span>Y\u00f6netmelik ayr\u0131ca &#8220;hijyen&#8221;, &#8220;hijyenik&#8221; veya benzeri kelimelerin kullan\u0131lmas\u0131n\u0131n bu t\u00fcr \u00fcr\u00fcnleri yanl\u0131\u015f markala\u015ft\u0131raca\u011f\u0131n\u0131 belirtiyor.<\/span>\n\n<hr \/>\n\n<b><span>K\u00f6p\u00fck Deterjan Banyo \u00dcr\u00fcnleri<\/span><a id=\"foaming\" name=\"foaming\"><\/a><\/b>\n\n<strong><em><span>Dikkat<\/span><\/em><span>\u00a0&#8211;Yaln\u0131zca belirtildi\u011fi \u015fekilde kullan\u0131n.\u00a0Uzun s\u00fcreli maruz kalman\u0131n a\u015f\u0131r\u0131 kullan\u0131m\u0131 ciltte ve idrar yollar\u0131nda tahri\u015fe neden olabilir.\u00a0K\u0131zar\u0131kl\u0131k, k\u0131zar\u0131kl\u0131k veya ka\u015f\u0131nt\u0131 meydana gelirse kullanmay\u0131 b\u0131rak\u0131n.\u00a0Tahri\u015fin devam etmesi durumunda doktorunuza dan\u0131\u015f\u0131n.\u00a0\u00c7ocuklar\u0131n eri\u015femeyece\u011fi yerlerde saklay\u0131n.<\/span><\/strong>\n\n<strong><span>21 CFR 740.17<\/span><\/strong>\n\n<span>K\u00f6p\u00fck banyosu \u00fcr\u00fcn\u00fc olarak da bilinen k\u00f6p\u00fckl\u00fc deterjan banyosu \u00fcr\u00fcn\u00fc, bu d\u00fczenlemenin amac\u0131 do\u011frultusunda &#8220;y\u00fczey aktif madde i\u00e7eren k\u00f6p\u00fck \u00fcretmek amac\u0131yla banyoya eklenmesi ama\u00e7lanan herhangi bir \u00fcr\u00fcn&#8221; olarak tan\u0131mlan\u0131r. deterjan veya k\u00f6p\u00fcrt\u00fcc\u00fc madde olarak.&#8221;<\/span>\n\n<span>Yukar\u0131da belirtilen uyar\u0131n\u0131n, yaln\u0131zca yeti\u015fkinler taraf\u0131ndan kullan\u0131lmas\u0131 ama\u00e7land\u0131\u011f\u0131 a\u00e7\u0131k\u00e7a belirtilmeyen, k\u00f6p\u00fckl\u00fc deterjan banyosu \u00fcr\u00fcnlerinin etiketinde bulunmas\u0131 zorunludur.\u00a0A\u015fa\u011f\u0131da, bir \u00fcr\u00fcn\u00fcn yaln\u0131zca yeti\u015fkinler taraf\u0131ndan kullan\u0131lmas\u0131 ama\u00e7land\u0131\u011f\u0131n\u0131 belirten iki etiket bildirimi \u00f6rne\u011fi verilmi\u015ftir: &#8220;\u00c7ocuklar\u0131n eri\u015femeyece\u011fi yerde saklay\u0131n&#8221; ve &#8220;Yaln\u0131zca yeti\u015fkinlerin kullan\u0131m\u0131 i\u00e7indir.&#8221;<\/span>\n\n<span>K\u00f6p\u00fck banyosu \u00fcr\u00fcn\u00fcn\u00fcn \u00e7ocuklar taraf\u0131ndan kullan\u0131lmas\u0131 ama\u00e7lan\u0131yorsa, &#8220;\u00c7ocuklar\u0131n eri\u015femeyece\u011fi yerde saklay\u0131n&#8221; ifadesi, &#8220;yeti\u015fkin g\u00f6zetimi d\u0131\u015f\u0131nda&#8221; \u015feklinde geni\u015fletilebilir.<\/span>\n\n<span>Y\u00f6netmelik ayr\u0131ca, \u00fcr\u00fcn\u00fcn &#8220;G\u00fcvenli kullan\u0131m i\u00e7in yeterli talimatlar\u0131 ta\u015f\u0131mal\u0131d\u0131r&#8221; etiketinin bulunmas\u0131n\u0131 gerektirmektedir.<\/span>\n\n<hr \/>\n\n<b><span>Kozmetik \u0130\u00e7erik Etiketlemesi<\/span><a id=\"clgl\" name=\"clgl\"><\/a><\/b>\n\n<strong><span>Azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re tat, koku ve ticari s\u0131r i\u00e7erik maddeleri d\u0131\u015f\u0131ndaki i\u00e7erik maddelerinin beyan\u0131<\/span><\/strong>\n\n<strong><span>21 CFR 701.3<\/span><\/strong>\n\n<span>Kozmetik i\u00e7erik etiketlemesi 1970&#8217;lerin ba\u015f\u0131nda bir sorun haline geldi.\u00a0\u0130\u00e7erik etiketlemesine ili\u015fkin k\u0131lavuzlar 1972&#8217;nin ortalar\u0131nda yay\u0131mland\u0131.\u00a0D\u00fczenlemeler 1973&#8217;\u00fcn ba\u015flar\u0131nda \u00f6nerildi. \u0130ki nihai d\u00fczenlemenin yay\u0131nlanmas\u0131, nihai d\u00fczenlemelerin y\u00fcr\u00fcrl\u00fckten kald\u0131r\u0131lmas\u0131, kal\u0131\u015flar\u0131n sona erdirilmesi ve yay\u0131nlanan d\u00fczenlemelerin yasall\u0131\u011f\u0131na itiraz eden uzun mahkeme i\u015flemlerinin ard\u0131ndan, kozmetik i\u00e7erik etiketleme zorunlulu\u011fu 1977&#8217;nin ba\u015flar\u0131nda tamamen y\u00fcr\u00fcrl\u00fc\u011fe girdi.<\/span>\n\n<span>Kozmetik i\u00e7erik maddelerinin beyan\u0131n\u0131 gerektiren d\u00fczenlemeler, FP&amp;L Yasas\u0131n\u0131n [sn.\u00a05(c) ve 6(a);\u00a015 USC 1454 ve 1455] ve FD&amp;C Yasas\u0131 [sn.\u00a0701(e);\u00a021 USC 371(e)].<\/span>\n\n<span>FP&amp;L Yasas\u0131, Kanunda tan\u0131mland\u0131\u011f\u0131 gibi yaln\u0131zca t\u00fcketici \u00fcr\u00fcnleri ve bunlar\u0131n ambalajlar\u0131 i\u00e7in ge\u00e7erli oldu\u011fundan, kozmetik i\u00e7erik beyanlar\u0131n\u0131n, geleneksel olarak perakende olarak sat\u0131lan veya evlerde y\u00fcr\u00fct\u00fclen hizmetlerin yerine getirilmesinde kullan\u0131lan kozmetiklerin yaln\u0131zca d\u0131\u015f kab\u0131n\u0131n etiketinde bulunmas\u0131 gerekmektedir.\u00a0\u00d6rne\u011fin, profesyonel kurulu\u015flarda kullan\u0131lan \u00fcr\u00fcnler veya \u00fccretsiz olarak da\u011f\u0131t\u0131lan numuneler i\u00e7in, bu t\u00fcr \u00fcr\u00fcnler geleneksel olarak perakende sat\u0131\u015fta sat\u0131lmad\u0131k\u00e7a, \u00fczerinde &#8220;Yaln\u0131zca profesyonel kullan\u0131m i\u00e7indir&#8221; etiketi olsa bile ge\u00e7erli de\u011fildir.<\/span>\n\n<span>\u0130\u00e7erikler azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re beyan edilmelidir.\u00a0Bu gereksinimin istisnalar\u0131 daha sonra ele al\u0131nacakt\u0131r.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>\u0130\u00e7erik Beyan\u0131&#8217;n\u0131n \u00d6nemi<\/span><a id=\"clgl1\" name=\"clgl1\"><\/a><\/b>\n\n<strong><span>Normal sat\u0131n alma ko\u015fullar\u0131 alt\u0131nda s\u0131radan ki\u015filer taraf\u0131ndan okunup anla\u015f\u0131lmas\u0131n\u0131 kolayla\u015ft\u0131racak \u015fekilde belirgin ve dikkat \u00e7ekici<\/span><\/strong>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" summary=\"layout\">\n<tbody>\n<tr>\n<td><span>Harf Y\u00fcksekli\u011fi<\/span><\/td>\n<td><strong><span>1\/16 in\u00e7<\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td><span>\u0130stisna:<\/span>\n<span>Mevcut toplam etiketleme y\u00fczey alan\u0131 12 in\u00e7 kareden azsa.<\/span><\/td>\n<td><strong><span>1\/32 in\u00e7<\/span><\/strong><\/td>\n<\/tr>\n<tr>\n<td><span>Bilgi paneli<\/span><\/td>\n<td>&nbsp;<\/td>\n<\/tr>\n<tr>\n<td><span>S\u0131k\u0131ca yap\u0131\u015ft\u0131r\u0131lm\u0131\u015f etiket, bant veya kart<\/span><\/td>\n<td>&nbsp;<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<strong><span>21 CFR 701.3(b) ve (p)<\/span><\/strong>\n\n<span>\u0130\u00e7erik beyan\u0131, e\u011fer yak\u0131n kap bu \u015fekilde paketlenmi\u015fse katlan\u0131r karton, kutu, ambalaj ka\u011f\u0131d\u0131 vb. formundaki d\u0131\u015f kap olan veya e\u011fer ambalajlanm\u0131\u015fsa kavanoz, \u015fi\u015fe, kutu vb. olan paketin herhangi bir bilgi panelinde g\u00f6r\u00fcnebilir. acil kap\u00a0bir d\u0131\u015f kapta paketlenmez\u00a0<\/span><strong><span>.\u00a0<\/span><\/strong><span>Ayr\u0131ca dekoratif veya k\u00fc\u00e7\u00fck boyutlu bir kaba s\u0131k\u0131ca yap\u0131\u015ft\u0131r\u0131lm\u0131\u015f bir etiket, bant veya kart \u00fczerinde de g\u00f6r\u00fcnebilir.<\/span>\n\n<strong><span>\u00d6ne \u00c7\u0131kma<\/span><\/strong><span>\u00a0: Beyan, normal sat\u0131n alma ko\u015fullar\u0131 alt\u0131nda s\u0131radan ki\u015filer taraf\u0131ndan okunabilmesi ve anla\u015f\u0131labilmesi (kolayl\u0131kla okunabilmesi) i\u00e7in belirgin ve dikkat \u00e7ekici bir \u015fekilde g\u00f6r\u00fcnmelidir.\u00a0Harfler tasar\u0131m, vinyet, arka plan veya kalabal\u0131kla\u015fma nedeniyle engellenmemelidir.<\/span>\n\n<strong><span>Tip Boyutu<\/span><\/strong><span>\u00a0: Y\u00fcksekli\u011fi 1\/16 in\u00e7ten az olmamal\u0131d\u0131r.\u00a0Etiketlemeyi ta\u015f\u0131yabilecek toplam y\u00fczey alan\u0131n\u0131n (alt, omuz, boyun, flan\u015f, dekoratif veya oymal\u0131 y\u00fczeyler hari\u00e7) 12 in\u00e7 kareden az olmas\u0131 durumunda y\u00fcksekli\u011fi 1\/32 in\u00e7ten az olamaz.<\/span>\n\n<span>B\u00fcy\u00fck ve k\u00fc\u00e7\u00fck harflerden olu\u015fan yaz\u0131 boyutu, k\u00fc\u00e7\u00fck &#8220;o&#8221; harfinin y\u00fcksekli\u011fine g\u00f6re belirlenir.<\/span>\n\n<span>\u0130\u00e7erik beyan\u0131, e\u011fer yak\u0131n kap bu \u015fekilde paketlenmi\u015fse katlan\u0131r karton, kutu, ambalaj ka\u011f\u0131d\u0131 vb. formundaki d\u0131\u015f kap olan veya e\u011fer ambalajlanm\u0131\u015fsa kavanoz, \u015fi\u015fe, kutu vb. olan paketin herhangi bir bilgi panelinde g\u00f6r\u00fcnebilir. acil kap\u00a0bir d\u0131\u015f kapta paketlenmez\u00a0<\/span><strong><span>.\u00a0<\/span><\/strong><span>Ayr\u0131ca dekoratif veya k\u00fc\u00e7\u00fck boyutlu bir kaba s\u0131k\u0131ca yap\u0131\u015ft\u0131r\u0131lm\u0131\u015f bir etiket, bant veya kart \u00fczerinde de g\u00f6r\u00fcnebilir.<\/span>\n\n<strong><span>\u00d6ne \u00c7\u0131kma<\/span><\/strong><span>\u00a0: Beyan, normal sat\u0131n alma ko\u015fullar\u0131 alt\u0131nda s\u0131radan ki\u015filer taraf\u0131ndan okunabilmesi ve anla\u015f\u0131labilmesi (kolayl\u0131kla okunabilmesi) i\u00e7in belirgin ve dikkat \u00e7ekici bir \u015fekilde g\u00f6r\u00fcnmelidir.\u00a0Harfler tasar\u0131m, vinyet, arka plan veya kalabal\u0131kla\u015fma nedeniyle engellenmemelidir.<\/span>\n\n<strong><span>Tip Boyutu<\/span><\/strong><span>\u00a0: Y\u00fcksekli\u011fi 1\/16 in\u00e7ten az olmamal\u0131d\u0131r.\u00a0Etiketlemeyi ta\u015f\u0131yabilecek toplam y\u00fczey alan\u0131n\u0131n (alt, omuz, boyun, flan\u015f, dekoratif veya oymal\u0131 y\u00fczeyler hari\u00e7) 12 in\u00e7 kareden az olmas\u0131 durumunda y\u00fcksekli\u011fi 1\/32 in\u00e7ten az olamaz.<\/span>\n\n<span>B\u00fcy\u00fck ve k\u00fc\u00e7\u00fck harflerden olu\u015fan yaz\u0131 boyutu, k\u00fc\u00e7\u00fck &#8220;o&#8221; harfinin y\u00fcksekli\u011fine g\u00f6re belirlenir.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Malzemelerin \u0130sme G\u00f6re Tan\u0131mlanmas\u0131<\/span><a id=\"clgl2\" name=\"clgl2\"><\/a><\/b>\n<ol>\n \t<li><strong><span>Komiser taraf\u0131ndan \u00a7 701.30&#8217;da belirtildi\u011fi gibi belirlenen isim.<\/span><\/strong><\/li>\n \t<li><strong><span>A\u015fa\u011f\u0131daki listede yer alan bile\u015fen i\u00e7in benimsenen ad:<\/span><\/strong>\n\n<strong><span>(a) CTFA Kozmetik \u0130\u00e7erik S\u00f6zl\u00fc\u011f\u00fc<\/span>\n<span>(b) Amerika Birle\u015fik Devletleri Farmakopesi<\/span>\n<span>(c) Ulusal Form\u00fcler<\/span>\n<span>(d) G\u0131da Kimyasallar\u0131 Kodeksi<\/span>\n<span>(e) USAN ve USP \u0130la\u00e7 \u0130simleri S\u00f6zl\u00fc\u011f\u00fc<\/span><\/strong><\/li>\n \t<li><strong><span>T\u00fcketiciler taraf\u0131ndan genel olarak tan\u0131nan ad<\/span><\/strong><\/li>\n \t<li><strong><span>Kimyasal veya teknik ad veya a\u00e7\u0131klama<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR 701.3(c)\u00a0<\/span><\/strong>\n\n<span>B\u00f6l\u00fcm 701.3(c), bir bile\u015fenin, kozmetik i\u00e7erik etiketlemesi amac\u0131yla Komiser taraf\u0131ndan belirlenen adla tan\u0131mlanmas\u0131n\u0131 veya Komiser taraf\u0131ndan belirlenen bir ad\u0131n bulunmamas\u0131 durumunda, s\u00f6z konusu i\u00e7erik maddesi i\u00e7in bu Y\u00f6netmeli\u011fin bask\u0131lar\u0131nda ve eklerinde benimsenen isimle tan\u0131mlanmas\u0131n\u0131 gerektirir. a\u015fa\u011f\u0131da listelenen \u00f6zet.<\/span>\n\n<span>Komiser, dilek\u00e7ede belirtildi\u011fi gibi bir isim belirleyebilir veya kendi inisiyatifiyle b\u00f6yle bir isim \u00f6nerebilir.\u00a0Bkz. b\u00f6l\u00fcm 701.3(e).\u00a0Komiser taraf\u0131ndan belirlenen isimler b\u00f6l\u00fcm 701.30&#8217;da listelenmi\u015ftir.<\/span>\n\n<span>CTFA&#8217;n\u0131n (Kozmetik, Tuvalet ve Koku Derne\u011fi, Inc.) Kozmetik \u0130\u00e7erik S\u00f6zl\u00fc\u011f\u00fc&#8217;n\u00fcn \u015fu anda tan\u0131nan bask\u0131s\u0131, 1977&#8217;de yay\u0131nlanan ikinci bask\u0131d\u0131r. Bu bask\u0131 yaln\u0131zca k\u0131smen tan\u0131nmaktad\u0131r, yani ikinci bask\u0131da listelenen adlar\u0131n t\u00fcm\u00fc benimsenmemi\u015ftir. .<\/span>\n\n<span>1982 y\u0131l\u0131nda yay\u0131nlanan CTFA Kozmetik \u0130\u00e7erik S\u00f6zl\u00fc\u011f\u00fc&#8217;n\u00fcn \u00fc\u00e7\u00fcnc\u00fc bask\u0131s\u0131 ve 1985 y\u0131l\u0131nda yay\u0131nlanan Ek hen\u00fcz tan\u0131nmam\u0131\u015ft\u0131r.\u00a0Ancak FDA, CTFA&#8217;ya, inceleme devam ederken kurumun bu bas\u0131mlara uygun olarak etiketlenen \u00fcr\u00fcnlere kar\u015f\u0131 d\u00fczenleyici i\u015flem yapmayaca\u011f\u0131n\u0131 bildirdi.<\/span>\n\n<span>\u00d6zetler, bir bile\u015fen ad\u0131n\u0131n tan\u0131mlanmas\u0131 i\u00e7in kullan\u0131lmas\u0131 gereken azalan s\u0131rada listelenmi\u015ftir.\u00a0Hi\u00e7biri bir bile\u015fen i\u00e7in bir isim listelemiyorsa, t\u00fcketiciler taraf\u0131ndan genel olarak tan\u0131nan isim veya kimyasal veya teknik isim veya a\u00e7\u0131klama kullan\u0131lmal\u0131d\u0131r.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>\u0130\u00e7erik Beyan\u0131 S\u0131ras\u0131<\/span><a id=\"clgl3\" name=\"clgl3\"><\/a><\/b>\n\n<strong><span>Azalan \u00fcst\u00fcnl\u00fck s\u0131ras\u0131<\/span><\/strong>\n\n<strong><span>\u0130stisnalar&#8230;<\/span>\n<span>Aktif ila\u00e7 i\u00e7erikleri<\/span>\n<span>%1&#8217;den daha az konsantrasyona sahip bile\u015fenler<\/span>\n<span>Renk katk\u0131 maddeleri<\/span>\n<span>&#8220;Ve di\u011fer bile\u015fenler&#8221;<\/span><\/strong>\n\n<strong><span>21 CFR 701.3(a), (d), (f) (2), (f) (3)<\/span><\/strong>\n\n<span>Malzemeler azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re listelenmelidir.\u00a0Ancak bu zorunlulu\u011fun birka\u00e7 istisnas\u0131 vard\u0131r.<\/span>\n\n<span>1. Kozmetik ayn\u0131 zamanda bir ila\u00e7 ise, FD&amp;C Yasas\u0131n\u0131n 502(c) b\u00f6l\u00fcm\u00fc, aktif ila\u00e7 i\u00e7erik(ler)inin kozmetik i\u00e7erik maddelerinin beyan\u0131ndan \u00f6nce beyan edilmesini gerektirir.\u00a0Dolay\u0131s\u0131yla bir beyan \u015fu \u015fekilde olacakt\u0131r: &#8220;Etkin \u0130\u00e7erik: &#8230; (\u0130la\u00e7 bile\u015feninin ad\u0131). Di\u011fer (veya Kozmetik) \u0130\u00e7erikler: &#8230; (Kozmetik i\u00e7erik maddelerinin azalan s\u0131rayla adlar\u0131).&#8221;\u00a0[\u00a7 701.3(d)]<\/span>\n\n<span>2. %1&#8217;i a\u015fmayan bir konsantrasyonda bulunan i\u00e7erik maddeleri, %1&#8217;den fazla mevcut olan i\u00e7erik maddelerinin azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re listelenmesinden sonra herhangi bir s\u0131rada listelenebilir.\u00a0[\u00a7 701.3(f)(2)]<\/span>\n\n<span>3. Herhangi bir konsantrasyondaki renk katk\u0131 maddeleri, renk katk\u0131 maddeleri olmayan i\u00e7erik maddelerinin listelenmesinden sonra herhangi bir s\u0131rayla listelenebilir [\u00a7 701.3(f)(3)].<\/span>\n\n<span>4. \u00a7 720.8&#8217;de ticari s\u0131r olarak belirlenen prosed\u00fcre uygun olarak FDA taraf\u0131ndan kabul edilen bir bile\u015fenin ad\u0131n\u0131n etiket \u00fczerinde a\u00e7\u0131klanmas\u0131na gerek yoktur.\u00a0Bu bile\u015fenin ad\u0131n\u0131 beyan etmek yerine, i\u00e7erik beyan\u0131n\u0131n sonunda &#8220;ve di\u011fer bile\u015fenler&#8221; ifadesi kullan\u0131labilir [\u00a7 701.3(a)].<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Hakimiyet S\u0131ras\u0131<\/span><\/b>\n\n<b><span>Ruj<\/span><\/b>\n<div class=\"table-responsive\">\n\n&nbsp;\n<table class=\"table table-bordered\" summary=\"layout\">\n<tbody>\n<tr>\n<td valign=\"top\"><strong><span>Yanl\u0131\u015f Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>Hint Ya\u011f\u0131 (58)<\/span><\/strong>\n\n<strong><span>Balmumu (6.5)<\/span><\/strong>\n\n<strong><span>Kandelilla Balmumu (6.5)<\/span><\/strong>\n\n<strong><span>Karnauba Balmumu (3)<\/span><\/strong>\n\n<strong><span>Lanolin (8)<\/span><\/strong>\n\n<strong><span>Ozokerit (2)<\/span><\/strong>\n\n<strong><span>Propilen Glikol (ve) BHA<\/span><\/strong>\n\n<strong><span>(Ve) Propil Gallat<\/span><\/strong>\n\n<strong><span>(Ve) Sitrik Asit (1.3)<\/span><\/strong>\n\n<strong><span>Titanyum Dioksit (2)<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No.21 (2)<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No. 6 Baryum G\u00f6l\u00fc (4)<\/span><\/strong>\n\n<strong><span>D&amp;C Sar\u0131 No. 5 Al\u00fcminyum Lake (5)<\/span><\/strong>\n\n<strong><span>Koku (0,5)<\/span><\/strong><\/td>\n<td><strong><span>Do\u011fru Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>Hint Ya\u011f\u0131<\/span><\/strong>\n\n<strong><span>Lanolin<\/span><\/strong>\n\n<strong><span>Balmumu<\/span><\/strong>\n\n<strong><span>Kandelilla Balmumu<\/span><\/strong>\n\n<strong><span>Karnauba mumu<\/span><\/strong>\n\n<strong><span>Ozokerit<\/span><\/strong>\n\n<strong><span>Propilen Glikol<\/span><\/strong>\n\n<strong><span>BHA<\/span><\/strong>\n\n<strong><span>Propil Gallat<\/span><\/strong>\n\n<strong><span>Sitrik asit<\/span><\/strong>\n\n<strong><span>Koku<\/span><\/strong>\n\n<strong><span>Titanyum dioksit<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No.21<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No. 6 Baryum G\u00f6l\u00fc<\/span><\/strong>\n\n<strong><span>D&amp;C Sar\u0131 No. 5 Al\u00fcminyum Lake<\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span>Bu \u00f6rnekte, do\u011fru i\u00e7erik beyan\u0131nda hint ya\u011f\u0131 (58), lanolin (8), kandelilla mumu (6,5), karnauba mumu (3) ve ozokerit (2) azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re listelenmektedir.\u00a0Konsantrasyonlar (y\u00f6netmelikle beyan edilmesi gerekmeyenler) parantez i\u00e7inde verilmi\u015ftir.<\/span>\n\n<span>Propilen glikol i\u00e7inde \u00e7\u00f6z\u00fcnm\u00fc\u015f tescilli antioksidan kar\u0131\u015f\u0131m\u0131n bile\u015fikleri, \u00fcr\u00fcn form\u00fclasyonuna entegre edilmeli ve &#8220;(ve)&#8221; terimi olmadan azalan bask\u0131nl\u0131k s\u0131ras\u0131na g\u00f6re ayr\u0131 ayr\u0131 beyan edilmelidir.<\/span>\n\n<span>Renk katk\u0131 maddeleri titanyum dioksit (2) vb. di\u011fer bile\u015fenlerden sonra herhangi bir s\u0131rayla beyan edilebilir.<\/span>\n\n<hr \/>\n\n<b><span>Renk Katk\u0131 Maddeleri ve Y\u00fczde Bir veya Daha Az Oranda Bulunan \u0130\u00e7eriklerin Beyan\u0131<\/span><\/b>\n\n<strong><span>Preslenmi\u015f Toz<\/span><\/strong>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" summary=\"layout\">\n<tbody>\n<tr>\n<td valign=\"top\"><strong><span>Etiket Beyan\u0131:<\/span><\/strong>\n\n<strong><span>Talk (75)<\/span><\/strong>\n\n<strong><span>Kaolin (7.5)<\/span><\/strong>\n\n<strong><span>\u00c7inko Stearat (5)<\/span><\/strong>\n\n<strong><span>Titanyum Dioksit (5)<\/span><\/strong>\n\n<strong><span>Madeni Ya\u011f (3)<\/span><\/strong>\n\n<strong><span>Demir Oksitler (2.5)<\/span><\/strong>\n\n<strong><span>\u0130zopropil Miristat (0,9)<\/span><\/strong>\n\n<strong><span>Lanolin Ya\u011f\u0131 (0,5)<\/span><\/strong>\n\n<strong><span>Lanolin (0,2)<\/span><\/strong>\n\n<strong><span>Koku (0,1)<\/span><\/strong>\n\n<strong><span>Ultramarin Mavi (0,05)<\/span><\/strong><\/td>\n<td valign=\"top\"><strong><span>Alternatif Beyan:<\/span><\/strong>\n\n<strong><span>Talk<\/span><\/strong>\n\n<strong><span>Kaolin<\/span><\/strong>\n\n<strong><span>\u00c7inko Stearat<\/span><\/strong>\n\n<strong><span>Mineral ya\u011f<\/span><\/strong>\n\n<strong><span>Lanolin<\/span><\/strong>\n\n<strong><span>Izopropil miristat<\/span><\/strong>\n\n<strong><span>Koku<\/span><\/strong>\n\n<strong><span>Lanolin Ya\u011f\u0131<\/span><\/strong>\n\n<strong><span>Titanyum dioksit<\/span><\/strong>\n\n<strong><span>Lacivert Mavi<\/span><\/strong>\n\n<strong><span>Demir oksitler<\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span>Bu \u00f6rnekte g\u00f6sterilen varsay\u0131msal preslenmi\u015f toz form\u00fclasyonu, bile\u015fenlerin listelenmesine y\u00f6nelik iki se\u00e7ene\u011fi g\u00f6stermektedir.<\/span>\n\n<span>Sol tarafta, i\u00e7erikler \u00a7 701.3(2)&#8217;ye g\u00f6re azalan \u00f6ncelik s\u0131ras\u0131na g\u00f6re listelenir.<\/span>\n\n<span>Sa\u011f tarafta, i\u00e7erik maddeleri \u00a7 701.3(f)(1), (2) ve (3)&#8217;e g\u00f6re listelenir, yani %1&#8217;i a\u015fan bir konsantrasyonda mevcut olan renkler d\u0131\u015f\u0131ndaki bile\u015fenler azalan s\u0131rada veya a\u011f\u0131rl\u0131kta, ard\u0131ndan Herhangi bir s\u0131rada %1 veya daha az bulunan renkler d\u0131\u015f\u0131ndaki bile\u015fenler ve ard\u0131ndan herhangi bir s\u0131rada listelenen herhangi bir konsantrasyonda bulunan renkler.<\/span>\n\n<hr \/>\n\n<b><span>Koku ve Lezzet \u0130\u00e7erikleri Beyan\u0131<\/span><a id=\"clgl4\" name=\"clgl4\"><\/a><\/b>\n\n<strong><span>Koku<\/span><\/strong>\n\n<strong><span>Lezzet<\/span><\/strong>\n\n<strong><span>Koku ve lezzet<\/span><\/strong>\n\n<strong><span>21 CFR 701.3(a)<\/span><\/strong>\n\n<span>Koku ve tat bile\u015fikleri, azalan \u00f6ncelik s\u0131ras\u0131na g\u00f6re &#8220;koku&#8221; ve &#8220;tat&#8221; olarak beyan edilebilir.\u00a0Bir koku bile\u015fi\u011fi ayn\u0131 zamanda aroma g\u00f6revi g\u00f6r\u00fcyorsa &#8220;aroma ve koku&#8221; olarak beyan edilmelidir.<\/span>\n\n<span>Bir kokunun veya aroman\u0131n bile\u015fenleri (i\u00e7erik maddeleri), uygun etiket adlar\u0131yla ayr\u0131 ayr\u0131 da beyan edilebilir.<\/span>\n\n<span>Maskeleme maddesi olarak g\u00f6rev yapan, yani bir \u00fcr\u00fcne fark edilebilir bir koku eklemeden istenmeyen k\u00f6t\u00fc kokuyu kapatan bile\u015fen veya bile\u015fenler kar\u0131\u015f\u0131m\u0131, bireysel adlar\u0131yla veya &#8220;koku&#8221; olarak (koku yerine) beyan edilebilir. daha iyi bir tan\u0131mlama).\u00a0Bir \u00fcr\u00fcnde \u00f6nemsiz d\u00fczeyde bulunan bir maskeleme maddesi, \u00a7 701.3(1)(2)(iii) uyar\u0131nca tesad\u00fcfi bir i\u00e7erik maddesi olarak de\u011ferlendirilebilir ve bu durumda etikette beyan edilmesine gerek yoktur.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Ticari S\u0131r \u0130\u00e7erikler Beyan\u0131<\/span><a id=\"clgl5\" name=\"clgl5\"><\/a><\/b>\n\n<strong><span>&#8220;Ve Di\u011fer Malzemeler&#8221; \u0130fadesiyle<\/span><\/strong>\n\n<strong><span>FDA taraf\u0131ndan \u00a7 720.8 prosed\u00fcr\u00fc uyar\u0131nca kamuya a\u00e7\u0131klanmaktan muaf olarak kabul edilmesi halinde.<\/span><\/strong>\n\n<strong><span>21 CFR 701.3(a)<\/span><\/strong>\n\n<span>FP&amp;L Yasas\u0131 b\u00f6l\u00fcm 5(c)(3)(B)&#8217;de [15 USC 1454(c)(3)(B)] \u015funu belirtmektedir: &#8220;hi\u00e7bir \u015fey&#8230; herhangi bir ticari s\u0131rr\u0131n if\u015fa edilmesini gerektirecek \u015fekilde kabul edilmeyecektir.&#8221;\u00a0Buna g\u00f6re, kozmetik i\u00e7erik etiketleme d\u00fczenlemesi, FDA&#8217;n\u0131n kamuya a\u00e7\u0131klanmaktan muaf oldu\u011funu kabul etti\u011fi bir i\u00e7erik maddesinin kimli\u011finin beyan edilmesini gerektirmemektedir.\u00a0Gizli bir bile\u015fenin ad\u0131n\u0131n beyan\u0131 yerine, i\u00e7erik beyan\u0131n\u0131n sonunda &#8220;ve di\u011fer bile\u015fenler&#8221; ifadesi kullan\u0131labilir.<\/span>\n\n<span>Ajans\u0131n, kozmetik bile\u015fen kimliklerinin gizlili\u011fine ili\u015fkin talepleri i\u015fleme koymak i\u00e7in izledi\u011fi politika, \u00a7 720.8 kapsam\u0131nda kanunla\u015ft\u0131r\u0131lm\u0131\u015ft\u0131r.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Ticari s\u0131r nedir?<\/span><\/b>\n\n<strong><span>Ticari s\u0131r, bir ki\u015finin i\u015finde kullan\u0131lan ve ki\u015fiye, onu bilmeyen veya kullanmayan rakiplere kar\u015f\u0131 avantaj elde etme f\u0131rsat\u0131 veren herhangi bir form\u00fcl, model, ara\u00e7 veya bilgi derlemesinden olu\u015fabilir.<\/span><\/strong>\n\n<strong><span>21 CFR 20,61<\/span><\/strong>\n\n<span>&#8220;Ticari s\u0131r nedir?&#8221; sorusu, &#8220;Bilgi Edinme \u00d6zg\u00fcrl\u00fc\u011f\u00fc Kanunu&#8221; olarak bilinen kanunun uygulanmas\u0131na ili\u015fkin 1974 y\u0131l\u0131nda yay\u0131mlanan y\u00f6netmeli\u011fin \u00a7 20.61(a) maddesinde yer alan &#8220;ticari s\u0131r&#8221; teriminin tan\u0131m\u0131 yeniden d\u00fczenlenerek cevaplanabilir. &#8221; (\u0130dari Prosed\u00fcrler Yasas\u0131&#8217;n\u0131n kamuyu bilgilendirme b\u00f6l\u00fcm\u00fc; 5 USC 552).<\/span>\n\n<hr \/>\n\n<b><span>Bir \u0130\u00e7erik Kimli\u011finin Kamuya A\u00e7\u0131klanmas\u0131ndan Muaf Tutulmas\u0131n\u0131 Talep Etme Prosed\u00fcr\u00fc<\/span><a id=\"clgl6\" name=\"clgl6\"><\/a><\/b>\n<ol>\n \t<li><strong><span>Bilgilerin sunulmas\u0131<\/span><\/strong>\n<div>\n\n<strong><span>Kozmetik form\u00fclasyon veya hammadde kompozisyon beyan\u0131 (Form 2512 VEYA 2513)<\/span><\/strong>\n\n<strong><span>Ticari gizlili\u011fi hakl\u0131 \u00e7\u0131karan fiili ve hukuki gerek\u00e7elerin beyan\u0131<\/span><\/strong>\n\n<strong><span>\u00d6nceden if\u015fa edilmemesi beyan\u0131 (\u00a7 20.81)<\/span><\/strong>\n\n<\/div><\/li>\n<\/ol>\n<strong><span>21 CFR720.8<\/span><\/strong>\n\n<span>Bir kozmetik bile\u015fenin kimli\u011fine ili\u015fkin ticari s\u0131r talebinin, yani etiket beyan\u0131ndan muafiyet talebinin i\u015fleme al\u0131nmas\u0131ndaki ilk ad\u0131m, a\u015fa\u011f\u0131daki bilgilerin FDA&#8217;ya sunulmas\u0131d\u0131r:<\/span>\n\n<span>(a) S\u00f6z konusu \u00fcr\u00fcn\u00fcn FD-2512 ve 2512a formlar\u0131na ili\u015fkin yar\u0131 kantitatif kozmetik form\u00fclasyon beyan\u0131.<\/span>\n\n<span>(b) Dilek\u00e7e sahibinin dayand\u0131\u011f\u0131 t\u00fcm verileri ve di\u011fer bilgileri (ayn\u0131 zamanda dilek\u00e7e sahibinin bildi\u011fi ve davac\u0131n\u0131n konumu a\u00e7\u0131s\u0131ndan olumsuz olan her t\u00fcrl\u00fc bilgiyi) i\u00e7eren, talebin fiili ve yasal dayanaklar\u0131n\u0131n tam bir beyan\u0131.<\/span>\n\n<span>Ger\u00e7ek dayanak beyan\u0131, bilimsel veya teknik verileri, raporlar\u0131, testleri ve FDA&#8217;n\u0131n bir bile\u015fenin kimli\u011finin ticari s\u0131r olarak nitelendirilip nitelendirilmedi\u011fini belirlerken dikkate ald\u0131\u011f\u0131 fakt\u00f6rleri ele alan di\u011fer ilgili bilgileri i\u00e7ermelidir.\u00a0(FDA&#8217;n\u0131n dikkate ald\u0131\u011f\u0131 fakt\u00f6rler ba\u015fka bir yerde belirtilmi\u015ftir.)<\/span>\n\n<span>(c) S\u00f6z konusu bile\u015fenin kimli\u011finin, \u00a7 20.81&#8217;de ayr\u0131nt\u0131l\u0131 olarak a\u00e7\u0131kland\u0131\u011f\u0131 gibi gizlilik a\u00e7\u0131s\u0131ndan uygun g\u00fcvenceler olmadan daha \u00f6nce hi\u00e7 kimseye a\u00e7\u0131klanmad\u0131\u011f\u0131na dair bir beyan.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Bir \u0130\u00e7erik Kimli\u011finin Kamuya A\u00e7\u0131klanmas\u0131ndan Muaf Tutulmas\u0131n\u0131 Talep Etme Prosed\u00fcr\u00fc<\/span><\/b>\n<ol>\n \t<li><strong><span>Bilgi G\u00f6nderimi<\/span><\/strong>\n<div>\n\n<strong><span>Kozmetik form\u00fclasyon veya hammadde kompozisyon beyan\u0131 (Form 2512 veya 2513)<\/span><\/strong>\n\n<strong><span>Ticari gizlili\u011fi hakl\u0131 \u00e7\u0131karan fiili ve hukuki gerek\u00e7elerin beyan\u0131<\/span><\/strong>\n\n<strong><span>\u00d6nceden if\u015fa edilmemesi beyan\u0131 (\u00a7 20.81).<\/span><\/strong>\n\n<\/div><\/li>\n \t<li><strong><span>Yeterlilik i\u00e7in verilerin g\u00f6zden ge\u00e7irilmesi<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR720.8<\/span><\/strong>\n\n<span>FDA, verilerin talebin esas\u0131n\u0131n incelenmesine izin vermek i\u00e7in yeterli olup olmad\u0131\u011f\u0131n\u0131 belirlemek i\u00e7in g\u00f6nderilen bilgileri inceler.<\/span>\n\n<span>Esasa ili\u015fkin bir gizlilik incelemesi y\u00fcr\u00fctmek i\u00e7in yeterli veri i\u00e7ermeyen bir talep iade edilir ve dilek\u00e7e sahibine, kurumun talebi incelemeye devam etmesini sa\u011flamak i\u00e7in gerekli olan ek bilgiler konusunda bilgi verilir.<\/span>\n\n<hr \/>\n\n<b><span>Bir \u0130\u00e7erik Kimli\u011finin Kamuya A\u00e7\u0131klanmas\u0131ndan Muaf Tutulmas\u0131n\u0131 Talep Etme Prosed\u00fcr\u00fc<\/span><\/b>\n<ol>\n \t<li><strong><span>Bilgilerin sunulmas\u0131<\/span><\/strong>\n<div>\n\n<strong><span>Hammadde kompozisyon beyan\u0131n\u0131n kozmetik form\u00fclasyonu (Form 2512 veya 2513)<\/span><\/strong>\n\n<strong><span>Ticari gizlili\u011fi hakl\u0131 \u00e7\u0131karan fiili ve hukuki gerek\u00e7elerin beyan\u0131<\/span><\/strong>\n\n<strong><span>\u00d6nceden if\u015fa edilmemesi beyan\u0131 (\u00a7 20.81)<\/span><\/strong>\n\n<\/div><\/li>\n \t<li><strong><span>Yeterlilik i\u00e7in verilerin g\u00f6zden ge\u00e7irilmesi<\/span><\/strong><\/li>\n \t<li><strong><span>Ticari gizlili\u011fin ge\u00e7ici olarak belirlenmesi<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR720.8<\/span><\/strong>\n\n<span>G\u00f6nderilen bilgi, talebin esas\u0131n\u0131n incelenmesine izin verecek kadar yeterli oldu\u011funda, FDA incelemeye devam eder.<\/span>\n\n<span>Ajans, dilek\u00e7e sahibiyle ayn\u0131 fikirde oldu\u011funda ve i\u00e7erik maddesinin kimli\u011finin ticari s\u0131r oldu\u011funa karar verdi\u011finde, etiket a\u00e7\u0131klamas\u0131ndan muafiyet talebi kabul edilir.\u00a0FDA dilek\u00e7e sahibiyle ayn\u0131 fikirde de\u011filse, kurum ge\u00e7ici olarak talebi reddeder.\u00a0Ticari s\u0131r talebinde bulunan ki\u015fiye, kurumun tespiti yaz\u0131l\u0131 olarak bildirilir.\u00a0Ge\u00e7ici bir ret durumunda FDA, dilek\u00e7e sahibini bu ge\u00e7ici karar\u0131 verirken dayand\u0131\u011f\u0131 gerek\u00e7eler konusunda bilgilendirir.<\/span>\n\n<hr \/>\n\n<b><span>Ticari S\u0131r Stat\u00fcs\u00fc Belirlenirken Dikkate Al\u0131nan Fakt\u00f6rler<\/span><\/b>\n\n<strong><span>1. Bilgi kamuya a\u00e7\u0131k m\u0131?<\/span><\/strong>\n<div>\n\n<strong><span>(a) Dilek\u00e7e sahibinin \u00f6nceden kamuya a\u00e7\u0131klanmas\u0131<\/span><\/strong>\n\n<strong><span>(b) Literat\u00fcrde kamuya a\u00e7\u0131klama<\/span><\/strong>\n\n<strong><span>(c) Gizlili\u011fi korumak i\u00e7in al\u0131nan \u00f6nlemler<\/span><\/strong>\n\n<\/div>\n<span>FDA bir gizlilik talebinin esas\u0131n\u0131 incelerken ve bir bile\u015fenin kimli\u011finin ticari s\u0131r olarak nitelendirilip nitelendirilmedi\u011fini belirlerken, a\u015fa\u011f\u0131daki \u00fc\u00e7 soruya yan\u0131t arayarak a\u015fa\u011f\u0131daki \u00fc\u00e7 temel fakt\u00f6r\u00fc g\u00f6z \u00f6n\u00fcnde bulundurur:<\/span>\n\n<span>1. \u0130\u00e7eri\u011fin kimli\u011fi ve kullan\u0131m amac\u0131 kamuoyu taraf\u0131ndan biliniyor mu?<\/span>\n\n<span>2. \u0130lgili bile\u015fenin ama\u00e7lanan kullan\u0131m\u0131n\u0131n de\u011feri var m\u0131?<\/span>\n\n<span>3. \u0130\u00e7eri\u011fin kimli\u011fi yasal yollarla kolayca elde edilebilir mi ve kullan\u0131m amac\u0131 kopyalanabilir mi?<\/span>\n\n<span>Bu sorular, verilen bilgilerin ticari s\u0131r olup olmad\u0131\u011f\u0131n\u0131n belirlenmesinde Haks\u0131z Fiillerin Yeniden Bildirilmesi&#8217;nin 757. b\u00f6l\u00fcm\u00fcne ili\u015fkin Yorum B&#8217;de dikkate al\u0131nan fakt\u00f6rlere dayanmaktad\u0131r.<\/span>\n\n<span>Bir bile\u015fenin kimli\u011finin ticari s\u0131r olarak nitelendirilip nitelendirilmedi\u011finin belirlenmesinde ayn\u0131 fakt\u00f6rler FDA taraf\u0131ndan da dikkate al\u0131nd\u0131\u011f\u0131ndan, ticari s\u0131r talep eden bir ki\u015finin gerek\u00e7e beyan\u0131nda bunlar\u0131 ger\u00e7ek\u00e7i ve ikna edici bir \u015fekilde ele almas\u0131 gerekir.<\/span>\n\n<span>Ama\u00e7lanan kullan\u0131m ko\u015fullar\u0131 alt\u0131nda bir bile\u015fenin kimli\u011fine ili\u015fkin kamunun bilgi sahibi olmamas\u0131, bilginin \u00e7al\u0131\u015fanlar veya dilek\u00e7e sahibinin i\u015findeki di\u011fer ki\u015filer taraf\u0131ndan ne \u00f6l\u00e7\u00fcde bilindi\u011fi, bilginin ilgili literat\u00fcrde kamuya ne \u00f6l\u00e7\u00fcde a\u00e7\u0131kland\u0131\u011f\u0131 ve \u00f6nlemlerin kapsam\u0131n\u0131n belgelenmesiyle kan\u0131tlanabilir. bilgilerin gizlili\u011fini korumak i\u00e7in dilek\u00e7e sahibi taraf\u0131ndan al\u0131nm\u0131\u015ft\u0131r.<\/span>\n\n<hr \/>\n\n<b><span>Ticari S\u0131r Stat\u00fcs\u00fc Belirlenirken Dikkate Al\u0131nan Fakt\u00f6rler<\/span><\/b>\n\n<strong><span>2. Bilginin de\u011feri var m\u0131?<\/span><\/strong>\n<div>\n\n<strong><span>(a) \u00dcr\u00fcn a\u00e7\u0131s\u0131ndan \u00f6nemi<\/span><\/strong>\n\n<strong><span>(b) \u00dcr\u00fcn karl\u0131l\u0131\u011f\u0131<\/span><\/strong>\n\n<strong><span>(c) \u00dcr\u00fcn\u00fcn gelecekteki pazar performans\u0131<\/span><\/strong>\n\n<strong><span>(d) Yat\u0131r\u0131m yap\u0131lan \u00e7aba ve mali kaynaklar<\/span><\/strong>\n\n<\/div>\n<span>S\u00f6z konusu bile\u015fenin kimli\u011fini ve kullan\u0131m amac\u0131n\u0131 bilmenin de\u011feri, bile\u015fenin \u00fcr\u00fcn form\u00fclasyonu a\u00e7\u0131s\u0131ndan \u00f6nemi a\u00e7\u0131s\u0131ndan belirlenebilir.\u00a0De\u011ferli olmas\u0131 i\u00e7in, bile\u015fenin kozmetik \u00fcr\u00fcn\u00fcn iddia edilen performans\u0131na veya di\u011fer ilgili \u00f6zelliklerine \u00f6nemli \u00f6l\u00e7\u00fcde katk\u0131da bulundu\u011fu ve talep edilen ticari s\u0131r niteli\u011findeki bile\u015feni i\u00e7ermeyen veya ilgili bile\u015fen yerine geleneksel ikame maddeleri i\u00e7eren bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn, kozmetikte kullan\u0131labilece\u011fi varsay\u0131lmal\u0131d\u0131r. e\u015fit derecede iyi performans g\u00f6stermesi veya ba\u015fka bir \u015fekilde belirli gereksinimleri kar\u015f\u0131lamas\u0131 beklenmez.\u00a0Ticari s\u0131r niteli\u011findeki i\u00e7eri\u011fi i\u00e7eren bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn veya geleneksel ikameleri i\u00e7eren bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn uygun kar\u015f\u0131la\u015ft\u0131rmal\u0131 testinin yan\u0131 s\u0131ra dilek\u00e7e sahibinin kozmetik \u00fcr\u00fcn\u00fcn\u00fcn ayn\u0131 kullan\u0131m kategorisindeki rakibin kozmetik \u00fcr\u00fcnlerine kar\u015f\u0131 test edilmesi, bu y\u00f6nde ger\u00e7eklere dayanan belgeler sa\u011flayabilir ve dolay\u0131s\u0131yla dilek\u00e7e sahibi i\u00e7in bilgilerin de\u011ferini g\u00f6sterebilir. .\u00a0\u0130\u00e7erik bilgisinin de\u011feri ayn\u0131 zamanda bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn gelecekteki pazar performans\u0131 veya k\u00e2rl\u0131l\u0131\u011f\u0131 a\u00e7\u0131s\u0131ndan da belirlenebilir.\u00a0Bununla birlikte, bu t\u00fcr bir de\u011fer de\u011ferlendirmesi genellikle zor ve kesin olmayan bir i\u015ftir ve genellikle bir de\u011fer de\u011ferlendirmesini destekleyecek \u00e7ok az ger\u00e7ek veri sa\u011flar.<\/span>\n\n<span>S\u00f6z konusu bile\u015feni i\u00e7eren ve talep edilen \u00f6zellikleri sa\u011flayan \u00fcr\u00fcn form\u00fclasyonunun geli\u015ftirilmesi i\u00e7in harcanan \u00e7aban\u0131n ve yat\u0131r\u0131lan mali kaynaklar\u0131n belgelenmesi, ticari s\u0131r talebini daha da destekleyebilir.<\/span>\n\n<hr \/>\n\n<b><span>Ticari S\u0131r Stat\u00fcs\u00fc Belirlenirken Dikkate Al\u0131nan Fakt\u00f6rler<\/span><\/b>\n\n<strong><span>3. Bilgi kolayca elde edilebilir mi veya \u00e7o\u011falt\u0131labilir mi?<\/span><\/strong>\n\n<span>S\u00f6z konusu bile\u015fenin kimli\u011finin ba\u015fkalar\u0131 taraf\u0131ndan uygun \u015fekilde elde edilmesinin veya kopyalanmas\u0131n\u0131n kolayl\u0131\u011f\u0131 veya zorlu\u011fu ile ilgili fakt\u00f6r, bir bile\u015fenin belirli bir \u00fcr\u00fcn kategorisindeki kozmetiklerde ama\u00e7lanan ama\u00e7 i\u00e7in nadir veya beklenmedik kullan\u0131m\u0131n\u0131n belgelenmesi veya tan\u0131mlamak i\u00e7in gerekli analitik metodolojinin karma\u015f\u0131kl\u0131\u011f\u0131.<\/span>\n\n<hr \/>\n\n<b><span>Bir \u0130\u00e7erik Kimli\u011finin Kamuya A\u00e7\u0131klanmas\u0131ndan Muaf Tutulmas\u0131n\u0131 Talep Etme Prosed\u00fcr\u00fc<\/span><\/b>\n<ol>\n \t<li><strong><span>Ticari Gizlili\u011fin nihai tespiti<\/span><\/strong>\n<ul>\n \t<li><strong><span>Kozmetik form\u00fclasyon veya hammadde kompozisyon beyan\u0131 (Form 2512 VEYA 2513)<\/span><\/strong><\/li>\n \t<li><strong><span>Ticari gizlili\u011fi hakl\u0131 \u00e7\u0131karan fiili ve hukuki gerek\u00e7elerin beyan\u0131<\/span><\/strong><\/li>\n \t<li><strong><span>\u00d6nceden if\u015fa edilmemesi beyan\u0131 (\u00a7 20.81)<\/span><\/strong><\/li>\n<\/ul>\n<\/li>\n \t<li><strong><span>Yeterlilik i\u00e7in verilerin g\u00f6zden ge\u00e7irilmesi<\/span><\/strong><\/li>\n \t<li><strong><span>Ticari gizlili\u011fin ge\u00e7ici olarak belirlenmesi<\/span><\/strong><\/li>\n \t<li><strong><span>Ticari gizlili\u011fin nihai tespiti<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR720.8<\/span><\/strong>\n\n<span>FDA ge\u00e7ici olarak bir talebi reddetmeye karar verdi\u011finde, dilek\u00e7e sahibi FDA&#8217;n\u0131n gizlilik talebini ge\u00e7ici olarak reddetti\u011fi kay\u0131tlar\u0131 geri \u00e7ekebilir.\u00a0Dilek\u00e7e sahibi ayr\u0131ca, ge\u00e7ici reddine ili\u015fkin yaz\u0131l\u0131 bildirimin al\u0131nd\u0131\u011f\u0131 tarihten itibaren 60 g\u00fcn i\u00e7inde ilgili ek bilgi ve arg\u00fcmanlar\u0131 sunabilir ve ajans\u0131n karar\u0131n\u0131 hem ek materyal hem de orijinal olarak g\u00f6nderilen bilgiler \u0131\u015f\u0131\u011f\u0131nda yeniden g\u00f6zden ge\u00e7irmesini talep edebilir.<\/span>\n\n<span>Dilek\u00e7e sahibinin yeni veriler sunmas\u0131 durumunda kurum, bu materyali ba\u015flang\u0131\u00e7ta sunulan bilgilerle birlikte de\u011ferlendirerek nihai karar\u0131n\u0131 verir.\u00a0Bu, nihai kurum eylemini te\u015fkil eder.\u00a0Dilek\u00e7e sahibine ajans\u0131n nihai karar\u0131 yaz\u0131l\u0131 olarak bildirilir.<\/span>\n\n<hr \/>\n\n<b><span>Bir \u0130\u00e7erik Kimli\u011finin Kamuya A\u00e7\u0131klanmas\u0131ndan Muaf Tutulmas\u0131n\u0131 Talep Etme Prosed\u00fcr\u00fc<\/span><\/b>\n<ol>\n \t<li><strong><span>Bilgi G\u00f6nderimi<\/span><\/strong>\n<ul>\n \t<li><strong><span>Kozmetik Form\u00fclasyon veya Hammadde Bile\u015fimi Beyan\u0131 (Form 2512 VEYA 2513)<\/span><\/strong><\/li>\n \t<li><strong><span>Ticari gizlili\u011fi hakl\u0131 \u00e7\u0131karan fiili ve hukuki gerek\u00e7elerin beyan\u0131<\/span><\/strong><\/li>\n \t<li><strong><span>\u00d6nceden if\u015fa edilmemesi beyan\u0131 (\u00a7 20.81)<\/span><\/strong><\/li>\n<\/ul>\n<\/li>\n \t<li><strong><span>Yeterlilik i\u00e7in verilerin g\u00f6zden ge\u00e7irilmesi<\/span><\/strong><\/li>\n \t<li><strong><span>Ticari gizlili\u011fin ge\u00e7ici olarak belirlenmesi<\/span><\/strong><\/li>\n \t<li><strong><span>Ticari gizlili\u011fin nihai tespiti<\/span><\/strong><\/li>\n \t<li><strong><span>5 USC B\u00f6l\u00fcm 7 uyar\u0131nca adli inceleme<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR720.8<\/span><\/strong>\n\n<span>Ajans\u0131n nihai karar\u0131na, 5 USC, B\u00f6l\u00fcm 7 uyar\u0131nca mahkemelerde itiraz edilebilir. B\u00f6yle bir tespitten sonraki 30 g\u00fcn i\u00e7inde dava a\u00e7\u0131l\u0131rsa, FDA, konu mahkemelerde nihai olarak karara ba\u011flanana kadar ilgili kay\u0131tlar\u0131 if\u015fa etmeyecektir.\u00a030 g\u00fcn i\u00e7inde dava a\u00e7\u0131lmazsa ve dilek\u00e7e sahibi, gizlilik talebi reddedilen kay\u0131tlar\u0131 geri \u00e7ekmezse, s\u00f6z konusu kay\u0131tlar FDA&#8217;n\u0131n dosyalar\u0131n\u0131n bir par\u00e7as\u0131 haline getirilecek ve talep \u00fczerine kamuya a\u00e7\u0131klanacakt\u0131r.<\/span>\n\n<span>Ajans, bir kozmetik bile\u015fenin kimli\u011finin ticari s\u0131r oldu\u011funa dair tespitini tamamlayana kadar, s\u00f6z konusu kozmetik \u00fcr\u00fcn\u00fcn, ilgili ki\u015finin kimlik beyan\u0131 yerine &#8220;ve di\u011fer bile\u015fenler&#8221; etiket ibaresini ta\u015f\u0131yamayaca\u011f\u0131 unutulmamal\u0131d\u0131r. gizlili\u011fi talep edilen i\u00e7erik.\u00a0Etikette &#8220;ve di\u011fer bile\u015fenler&#8221; ibaresi, yaln\u0131zca bir bile\u015fenin FDA taraf\u0131ndan kamuya if\u015fa edilmekten muaf olarak kabul edilmesinden sonra veya gizlili\u011fin reddedilmesi durumunda, s\u00f6z konusu bile\u015fenin nihai olarak tespit edilmesinden sonraki 30 g\u00fcn i\u00e7inde dava a\u00e7\u0131lmas\u0131 durumunda kullan\u0131labilir. ticari s\u0131r de\u011fildir.<\/span>\n\n<hr \/>\n\n<b><span>Ayn\u0131 zamanda \u0130la\u00e7 Olan Kozmetikler<\/span><a id=\"clgl7\" name=\"clgl7\"><\/a><\/b>\n\n<strong><span>beyan<\/span><\/strong>\n<ol>\n \t<li><strong><span>B\u00f6l\u00fcm 2&#8217;ye uygun olarak herhangi bir aktif ila\u00e7 bile\u015feninin belirlenmi\u015f ad\u0131 ve herhangi bir alkol\u00fcn miktar\u0131, t\u00fcr\u00fc ve oran\u0131.\u00a0FD&amp;C Yasas\u0131n\u0131n 502(e) maddesi &#8220;Aktif \u0130\u00e7erikler&#8221; olarak<\/span><\/strong><\/li>\n \t<li><strong><span>Geri kalan bile\u015fenler, \u00a7 701.3&#8217;e uygun olarak &#8220;Kozmetik \u0130\u00e7erikler&#8221; olarak an\u0131l\u0131r.<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR 701.3(d)<\/span><\/strong>\n\n<span>\u0130nsan v\u00fccuduna temizleme, g\u00fczelle\u015ftirme, \u00e7ekicili\u011fi art\u0131rma veya g\u00f6r\u00fcn\u00fcm\u00fc de\u011fi\u015ftirme amac\u0131yla uygulanan \u00fcr\u00fcn kozmetiktir.\u00a0Bu \u00fcr\u00fcn, bu eylemleri fizyolojik aktivite yoluyla veya cildin yap\u0131s\u0131n\u0131 de\u011fi\u015ftirerek ger\u00e7ekle\u015ftirdi\u011fini iddia ediyorsa, ayn\u0131 zamanda bir ila\u00e7t\u0131r.\u00a0&#8220;\u0130la\u00e7&#8221; ve &#8220;kozmetik&#8221; \u00fcr\u00fcn kategorileri birbirini d\u0131\u015flamaz.\u00a0Bu, saniyede tan\u0131n\u0131r.\u00a0FD&amp;C Yasas\u0131n\u0131n 509&#8217;u.<\/span>\n\n<span>Bir kozmetik ayn\u0131 zamanda bir ila\u00e7 ise, etikette \u00f6ncelikle ilac\u0131n i\u00e7erik maddesinin\/maddelerinin belirlenmi\u015f ad\u0131 ve herhangi bir alkol\u00fcn miktar\u0131, t\u00fcr\u00fc ve oran\u0131 B\u00f6l\u00fcm 1&#8217;e uygun olarak listelenmelidir.\u00a0FD&amp;C Yasas\u0131&#8217;n\u0131n 502(e) maddesinde &#8220;Aktif \u0130\u00e7erikler&#8221; olarak ve ard\u0131ndan geri kalan bile\u015fenler, \u00a7 701.3(a) veya (f) uyar\u0131nca &#8220;Kozmetik \u0130\u00e7erikler&#8221; olarak an\u0131l\u0131r.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Ayn\u0131 zamanda \u0130la\u00e7 Olan Kozmetikler<\/span><\/b>\n\n<strong><span>Aerosol Terleme \u00d6nleyici<\/span><\/strong>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" summary=\"layout\">\n<tbody>\n<tr>\n<td valign=\"top\"><strong><span>Yanl\u0131\u015f Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>sob\u00fctan<\/span><\/strong>\n\n<strong><span>Silikon ya\u011f\u0131<\/span><\/strong>\n\n<strong><span>B\u00fctan<\/span><\/strong>\n\n<strong><span>Al\u00fcminyum Klorohidrat<\/span><\/strong>\n\n<strong><span>Izopropil miristat<\/span><\/strong>\n\n<strong><span>Denat\u00fcre Alkol<\/span><\/strong>\n\n<strong><span>Propan<\/span><\/strong>\n\n<strong><span>Benton 38<\/span><\/strong><\/td>\n<td><strong><span>Do\u011fru Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>Aktif bile\u015fen:<\/span><\/strong>\n\n<strong><span>Al\u00fcminyum Klorohidrat<\/span><\/strong>\n\n<strong><span>Kozmetik Malzemeler:<\/span><\/strong>\n\n<strong><span>\u0130zob\u00fctan<\/span><\/strong>\n\n<strong><span>Siklometikon<\/span><\/strong>\n\n<strong><span>B\u00fctan<\/span><\/strong>\n\n<strong><span>Izopropil miristat<\/span><\/strong>\n\n<strong><span>SD Alkol 40<\/span><\/strong>\n\n<strong><span>Propan<\/span><\/strong>\n\n<strong><span>Kuaterniyum 18 Hektorit\u00a0<\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span>Bu varsay\u0131msal aerosol terlemeyi \u00f6nleyici form\u00fclasyon, sa\u011f tarafta ayn\u0131 zamanda bir ila\u00e7 olan bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn bile\u015fenlerinin do\u011fru etiket beyan\u0131n\u0131 g\u00f6stermektedir.<\/span>\n\n<span>Aktif ila\u00e7 bile\u015feni al\u00fcminyum klorohidrat, b\u00f6l\u00fcm 1&#8217;e uygun olarak &#8220;Etkin Madde&#8221; olarak tan\u0131mlan\u0131r.\u00a0FD&amp;C Kanunu&#8217;nun 502(e)&#8217;si.\u00a0Geriye kalan bile\u015fenler g\u00f6sterildi\u011fi gibi &#8220;Kozmetik Malzemeler&#8221; veya &#8220;Di\u011fer Malzemeler&#8221; olarak tan\u0131mlanabilir.<\/span>\n\n<hr \/>\n\n<b><span>Renk E\u015fle\u015ftirme \u0130\u00e7in Bazen Renk Katk\u0131 Maddeleri Eklenir<\/span><a id=\"clgl8\" name=\"clgl8\"><\/a><\/b>\n\n<strong><span>Di\u011fer renk katk\u0131 maddelerinin beyan\u0131ndan sonra ve &#8220;\u0130\u00e7erebilir&#8221; ibaresinden sonra listelenmi\u015ftir.<\/span><\/strong>\n\n<strong><span>21 CFR 701.3(g) (1)<\/span><\/strong>\n\n<span>Renk e\u015fle\u015ftirme amac\u0131yla bir kozmetik \u00fcr\u00fcne \u00fcretim s\u0131ras\u0131nda eklenen renk katk\u0131 maddesi\/katk\u0131 maddeleri, her partide veya partide mevcut olmasa bile her serinin veya partinin etiketinde beyan edilebilir.<\/span>\n\n<span>Bazen renk uyumu i\u00e7in eklenen renk katk\u0131 maddesi, di\u011fer renk katk\u0131 maddelerinin beyan\u0131ndan sonra veya beyan\u0131n sonunda &#8220;\u0130\u00e7erebilir&#8221; ibaresinden sonra listelenir.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" target=\"_blank\" rel=\"noopener\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Renk E\u015fle\u015ftirme \u0130\u00e7in Bazen Renk Katk\u0131 Maddeleri Eklenir<\/span><\/b>\n\n<strong><span>Tuvalet suyu<\/span><\/strong>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" summary=\"layout\">\n<tbody>\n<tr>\n<td valign=\"top\"><strong><span>Yanl\u0131\u015f Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>SD Alkol 39C<\/span><\/strong>\n\n<strong><span>su<\/span><\/strong>\n\n<strong><span>Koku<\/span><\/strong>\n\n<strong><span>Propilen Glikol<\/span><\/strong>\n\n<strong><span>Setil Laktat<\/span><\/strong>\n\n<strong><span>FD&amp;C K\u0131rm\u0131z\u0131 No.40<\/span><\/strong>\n\n<strong><span>FD&amp;C Mavi No.1<\/span><\/strong>\n\n&nbsp;<\/td>\n<td><strong><span>Do\u011fru Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>SD Alkol 39C<\/span><\/strong>\n\n<strong><span>su<\/span><\/strong>\n\n<strong><span>Koku<\/span><\/strong>\n\n<strong><span>Propilen Glikol<\/span><\/strong>\n\n<strong><span>Setil Laktat<\/span><\/strong>\n\n<strong><span>FD&amp;C K\u0131rm\u0131z\u0131 No.40<\/span><\/strong>\n\n<strong><span>FD&amp;C Mavi No.1<\/span><\/strong>\n\n<strong><span>\u0130\u00e7erebilir:<\/span><\/strong>\n\n<strong><span>D&amp;C Sar\u0131 No.10\u00a0<\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<strong><span>Renk Ayar\u0131 i\u00e7in kullan\u0131lan D&amp;C Sar\u0131 No. 10\u00a0<\/span><\/strong>\n\n<span>Renk ayarlamas\u0131 amac\u0131yla baz\u0131 partilere D&amp;C Yellow No. 10&#8217;un eklendi\u011fi bu varsay\u0131msal tuvalet suyu form\u00fclasyonu, sa\u011f tarafta D&amp;C Yellow No. 10 renk katk\u0131 maddesinin do\u011fru etiket beyan\u0131n\u0131 g\u00f6sterir.<\/span>\n\n<hr \/>\n\n<b><span>Tesad\u00fcfi Malzemeler<\/span><a id=\"clgl9\" name=\"clgl9\"><\/a><\/b>\n\n<strong><span>Tan\u0131m:<\/span>\n<span>Eklenen, \u00e7\u0131kar\u0131lan veya beyan edilen bir bile\u015fene d\u00f6n\u00fc\u015ft\u00fcr\u00fclen herhangi bir i\u015flem yard\u0131mc\u0131 maddesi<\/span>\n<span>or<\/span>\n<span>\u00d6nemsiz d\u00fczeyde mevcut olan ve teknik veya i\u015flevsel etkisi olmayan ba\u015fka bir bile\u015fen veya i\u015flem yard\u0131mc\u0131s\u0131n\u0131n herhangi bir bile\u015feni<\/span><\/strong>\n\n<strong><span>Beyan edilmesine gerek yok<\/span><\/strong>\n\n<span>Ar\u0131zi i\u00e7eriklerin etikette belirtilmesine gerek yoktur.<\/span>\n\n<span>Ar\u0131zi bir i\u00e7erik madde \u00a7 701.3(1)&#8217;de \u015fu \u015fekilde tan\u0131mlan\u0131r:<\/span>\n\n<span>1. Kozmetik bitmi\u015f halde paketlenmeden \u00f6nce iyi \u00fcretim uygulamalar\u0131na uygun olarak \u00fcretim s\u0131ras\u0131nda eklenen ve kozmetikten \u00e7\u0131kar\u0131lan madde.\u00a0\u00d6rnek: Filtre yard\u0131m\u0131.<\/span>\n\n<span>2. Bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn \u00fcretimi s\u0131ras\u0131nda eklenen, etikette belirtilen i\u00e7erik maddesine d\u00f6n\u00fc\u015ft\u00fcr\u00fclen ve beyan edilen i\u00e7eri\u011fin konsantrasyonunu \u00f6nemli \u00f6l\u00e7\u00fcde art\u0131rmayan madde.\u00a0\u00d6rnek: Sodyum stearat ve stearik asit i\u00e7eren kozmetik \u00fcr\u00fcne eklenen sodyum hidroksit.<\/span>\n\n<span>3. Bir kozmeti\u011fe \u00fcretim s\u0131ras\u0131nda teknik etkisi nedeniyle eklenen, ancak bitmi\u015f kozmetikte \u00f6nemsiz d\u00fczeyde bulunan ve o kozmetikte herhangi bir teknik veya i\u015flevsel etkisi olmayan madde.\u00a0\u00d6rnek: K\u00f6p\u00fck giderici madde.<\/span>\n\n<span>4. Bir kozmetik bile\u015fenin bile\u015feni olarak bir kozmetik \u00fcr\u00fcne eklenen ve bitmi\u015f kozmetik \u00fczerinde hi\u00e7bir teknik veya i\u015flevsel etkisi olmayan bir madde.\u00a0\u00d6rnek: Bir kozmetik \u00fcr\u00fcn\u00fcne, koruyucu maddeyi art\u0131k etkili olmayaca\u011f\u0131 bir d\u00fczeye indiren bir konsantrasyonda i\u00e7erik olarak eklenen bir ham maddenin koruyucusu.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>\u00c7ok Birimli veya \u00c7ok Bile\u015fenli Paketler<\/span><\/b>\n\n<strong><span>\u00d6rnekler:<\/span>\n<span>Hediyelik makyaj seti seti<\/span>\n<span>Sa\u00e7 boyama seti veya evde kal\u0131c\u0131<\/span>\n<span>Beyan:<\/span>\n<span>Yaln\u0131zca bile\u015fenler geleneksel olarak tek tek sat\u0131lm\u0131yorsa d\u0131\u015f perakende ambalaj\u0131nda.<\/span><\/strong>\n\n<strong><span>21 CFR 701.3 (q)<\/span><\/strong>\n\n<span>\u00c7ok \u00fcniteli veya \u00e7ok bile\u015fenli ambalajlar halinde pazarlanan kozmetik \u00fcnitelerinin i\u00e7erikleri, d\u0131\u015f ambalaj\u0131n etiketinde beyan edilmelidir.\u00a0Bireysel perakende sat\u0131\u015f i\u00e7in i\u00e7 konteyn\u0131rlar\u0131n geleneksel olarak d\u0131\u015f konteyn\u0131rdan ayr\u0131lmas\u0131 durumunda, bunlar\u0131n \u00fcnitelerin i\u00e7 konteyn\u0131rlar\u0131n\u0131n etiketlerinde de beyan edilmesi gerekir.<\/span>\n\n<span>MULTIUNIT paketi, benzer veya farkl\u0131 \u00fcr\u00fcn \u00e7e\u015fitlerini i\u00e7eren bir pakettir.\u00a0\u00d6rnekler: Bir g\u00f6z makyaj\u0131 setindeki g\u00f6z far\u0131 \u00e7e\u015fitleri veya hediye kutusunda losyon, pudra ve tuvalet suyundan olu\u015fan bir hediye seti.<\/span>\n\n<span>\u00c7OK B\u0130LE\u015eENL\u0130 paket, &#8220;tam bir kiti olu\u015fturan entegre bile\u015fenleri i\u00e7eren ve bile\u015fenleri bir uygulama \u015feklinde sunmak \u00fczere tasarlanm\u0131\u015f bir pakettir.&#8221;\u00a0Bak\u0131n\u0131z 21 CFR 701.13(g)(2).\u00a0\u00d6rnekler: Boya \u00e7\u00f6zeltisi ve hidrojen peroksitten olu\u015fan bir sa\u00e7 boyama kiti veya tiyoglikolat \u00e7\u00f6zeltisi ve sodyum bromat \u00e7\u00f6zeltisinden olu\u015fan kal\u0131c\u0131 bir dalga seti.<\/span>\n\n<hr \/>\n\n<b><span>\u00c7oklu \u00dcnite Paketleri (Ayn\u0131 Pakette \u00c7e\u015fitler)<\/span><\/b>\n\n<strong><span>Farkl\u0131 \u00fcr\u00fcnler<\/span><\/strong>\n\n<strong><span>Ayn\u0131 kullan\u0131ma y\u00f6nelik benzer \u00fcr\u00fcnler<\/span><\/strong>\n\n<strong><span>Etiketleme y\u00fczey alan\u0131<\/span>\n<span>12 in\u00e7 kareden az<\/span>\n<span>12 in\u00e7 kareden fazla<\/span>\n<span>Markal\u0131 g\u00f6lge \u00e7izgileri<\/span>\n<span>Tek \u00fcniteler ve \u00e7e\u015fitler<\/span><\/strong>\n\n<span>Kozmetik i\u00e7erik etiketlemesi amac\u0131yla ve bazen i\u00e7erik maddelerinin birim birim tekrarl\u0131 listelenmesi yerine birle\u015ftirilmi\u015f i\u00e7erik listesi h\u00fck\u00fcmlerinden yararlanmak amac\u0131yla, a\u015fa\u011f\u0131dakileri i\u00e7eren paketler aras\u0131nda bir ayr\u0131m yap\u0131lmal\u0131d\u0131r:<\/span>\n\n<span>1. Farkl\u0131 \u00fcr\u00fcnler.\u00a0\u00d6rnek: T\u0131ra\u015f kremi ve t\u0131ra\u015f sonras\u0131 losyonu i\u00e7eren hediye seti.<\/span>\n\n<strong><span>2. Etiketleme i\u00e7in toplam y\u00fczey alan\u0131 12 in\u00e7 kare veya daha fazla<\/span><\/strong><span>\u00a0olan bir pakette ayn\u0131 kullan\u0131ma y\u00f6nelik ve benzer bile\u015fime sahip \u00fcr\u00fcnler\u00a0.\u00a0\u00d6rnek: Hediye setinde farkl\u0131 koku ve renkte iki tuvalet suyu.<\/span>\n\n<span>3. Etiketleme i\u00e7in toplam y\u00fczey alan\u0131\u00a0<\/span><strong><span>12 in\u00e7 kareden az olan,<\/span><\/strong><span>\u00a0benzer bile\u015fime sahip ve ayn\u0131 kullan\u0131m i\u00e7in tasarlanm\u0131\u015f \u00fcr\u00fcnler .\u00a0\u00d6rnek: Kompakt bir kutuda farkl\u0131 renkteki g\u00f6z farlar\u0131.<\/span>\n\n<span>4. Tekli birimler veya markal\u0131 bir g\u00f6lge serisinin \u00e7e\u015fitleri olan \u00fcr\u00fcnler.\u00a0Markal\u0131 bir g\u00f6lge serisi, ayn\u0131 kullan\u0131ma y\u00f6nelik ve ayn\u0131 marka ad\u0131yla ortak bir etiketi payla\u015fan, benzer bile\u015fime sahip bir dizi \u00fcr\u00fcnd\u00fcr.\u00a0\u00d6rnek: Rujlar\u0131n g\u00f6lge \u00e7izgisi.<\/span>\n\n<hr \/>\n\n<b><span>Farkl\u0131 \u00dcr\u00fcn \u00c7e\u015fitleri<\/span><a id=\"clgl10\" name=\"clgl10\"><\/a><\/b>\n\n<strong><span>Alternatif Beyan<\/span>\n<span>Renk katk\u0131 maddelerinin tek bile\u015fik listesi ve listenin t\u00fcm \u00fcr\u00fcnlerle ilgili oldu\u011fu beyan\u0131<\/span><\/strong>\n\n<strong><span>21 CFR 701.3(h)<\/span><\/strong>\n\n<span>Birbirine benzemeyen \u00fcr\u00fcnlerden olu\u015fan bir paket, yani \u00e7ok \u00fcniteli bir paket, \u00f6rne\u011fin bir hediye kutusundaki tuvalet suyu ve toz alma tozu a\u015fa\u011f\u0131dakileri ta\u015f\u0131yabilir:<\/span>\n\n<span>Her bir \u00fcr\u00fcn\u00fcn her bir bile\u015feninin uygun bir \u00fcr\u00fcn ba\u015fl\u0131\u011f\u0131 alt\u0131nda tan\u0131mland\u0131\u011f\u0131\u00a0<\/span><strong><span>geleneksel<\/span><\/strong><span>\u00a0bir i\u00e7erik beyan\u0131 veya<\/span>\n\n<span>\u00dcr\u00fcn yelpazesindeki t\u00fcm \u00fcr\u00fcnlerin renk katk\u0131 maddelerinin, listenin t\u00fcm \u00fcr\u00fcnler i\u00e7in ge\u00e7erli oldu\u011funu belirten tek bir bile\u015fik listeye entegre edildi\u011fi\u00a0<\/span><strong><span>alternatif<\/span><\/strong><span>\u00a0i\u00e7erik beyan\u0131.<\/span>\n\n<span>Bir \u00fcr\u00fcn \u00e7e\u015fidinin birimleri perakende sat\u0131\u015f i\u00e7in geleneksel olarak d\u0131\u015f ambalajdan ayr\u0131l\u0131yorsa, i\u00e7erik maddelerinin her bir i\u00e7 birimin etiketinde de belirtilmesi gerekti\u011fini l\u00fctfen unutmay\u0131n.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Farkl\u0131 \u00dcr\u00fcn \u00c7e\u015fitleri<\/span><\/b>\n\n<strong><span>Tuvalet Suyu ve Toz Alma Tozu<\/span><\/strong>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" summary=\"layout\">\n<tbody>\n<tr>\n<td valign=\"top\"><strong><span>Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>Tuvalet suyu:<\/span><\/strong>\n\n<span>SD Alkol 40<\/span>\n\n<span>su<\/span>\n\n<span>Koku<\/span>\n\n<span>FD&amp;C K\u0131rm\u0131z\u0131 No.40<\/span>\n\n<span>FD&amp;C Mavi No.1<\/span>\n\n<strong><span>Toz pudra:<\/span><\/strong>\n\n<span>Talk<\/span>\n\n<span>Kaolin<\/span>\n\n<span>Koku<\/span>\n\n<span>D&amp;C K\u0131rm\u0131z\u0131 No 21 Al\u00fcminyum Lake\u00a0<\/span><\/td>\n<td valign=\"top\"><strong><span>Alternatif Etiket:<\/span><\/strong>\n\n<strong><span>Tuvalet suyu:<\/span><\/strong>\n\n<span>SD Alkol 40<\/span>\n\n<span>su<\/span>\n\n<span>Koku<\/span>\n\n<strong><span>Tozu Tozu:<\/span><\/strong>\n\n<span>Talk<\/span>\n\n<span>Kaolin<\/span>\n\n<span>Koku<\/span>\n\n<span>Her \u0130ki \u00dcr\u00fcne Ait Renk Katk\u0131lar\u0131:<\/span>\n\n<span>FD&amp;C K\u0131rm\u0131z\u0131 No.40<\/span>\n\n<span>FD&amp;C Mavi No.1<\/span>\n\n<span>D&amp;C K\u0131rm\u0131z\u0131 No. 21 Al\u00fcminyum Lake\u00a0<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span>Tuvalet suyu ve toz alma tozundan olu\u015fan farkl\u0131 \u00fcr\u00fcnlerin varsay\u0131msal \u00e7e\u015fitlili\u011fine ili\u015fkin bu \u00f6rnek, sa\u011f tarafta, t\u00fcm renk katk\u0131 maddelerinin tek bir bile\u015fik listede beyan edildi\u011fi alternatif i\u00e7erik etiketleme se\u00e7ene\u011fini g\u00f6stermektedir.\u00a0Beyannamede renk katk\u0131 maddelerinin her iki \u00fcr\u00fcne de ait oldu\u011fu belirtiliyor.<\/span>\n\n<span>\u00d6rne\u011fin K\u0131rm\u0131z\u0131 40 veya Mavi 1 her iki \u00fcr\u00fcnde de mevcut olsayd\u0131, bunlar\u0131n beyanda yaln\u0131zca bir kez listelenmesi gerekirdi.<\/span>\n\n<hr \/>\n\n<b><span>Ayn\u0131 Kullan\u0131ma Y\u00f6nelik Benzer \u00dcr\u00fcn \u00c7e\u015fitleri<\/span><a id=\"clgl11\" name=\"clgl11\"><\/a><\/b>\n\n<span>Mevcut Etiketleme Y\u00fczey Alan\u0131 12 \u0130n\u00e7 Kareden Az<\/span>\n\n<strong><span>Alternatif Beyan<\/span><\/strong>\n<ol>\n \t<li><strong><span>K\u00fcm\u00fclatif azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re (veya paragraf (f)&#8217;ye g\u00f6re) listelenen t\u00fcm \u00fcr\u00fcnler i\u00e7in ortak olan i\u00e7erikler ve<\/span><\/strong><\/li>\n \t<li><strong><span>Kullan\u0131lan \u00fcr\u00fcne g\u00f6re tan\u0131mlanan t\u00fcm \u00fcr\u00fcnlerde ortak olmayan bile\u015fenler ve<\/span><\/strong><\/li>\n \t<li><strong><span>\u00dcr\u00fcn tan\u0131mlamas\u0131 olmayan t\u00fcm renk katk\u0131 maddelerinin tek bile\u015fik listesi<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR 701.3 (O) (1)<\/span><\/strong>\n\n<strong><span>Benzer bile\u015fime sahip ve etiketleme i\u00e7in toplam y\u00fczey alan\u0131 12 in\u00e7 kare veya daha fazla<\/span><\/strong><span>\u00a0olan bir pakette ayn\u0131 kullan\u0131m i\u00e7in ama\u00e7lanan \u00fcr\u00fcn \u00e7e\u015fitleri,\u00a0\u00f6rne\u011fin bir hediye setindeki farkl\u0131 koku veya renkte iki tuvalet suyu, etiketlenebilir. herhangi biri:<\/span>\n\n<span>Her bir \u00fcr\u00fcn\u00fcn i\u00e7erik maddelerinin uygun \u00fcr\u00fcn ba\u015fl\u0131klar\u0131 alt\u0131nda tan\u0131mland\u0131\u011f\u0131, ya t\u00fcm i\u00e7erik maddelerinin \u00a7 701.3(a)&#8217;ya g\u00f6re azalan \u00f6ncelik s\u0131ras\u0131na g\u00f6re listelendi\u011fi ya da i\u00e7erik maddelerinin \u00a7 701.3(f)&#8217;ye g\u00f6re listelendi\u011fi ve ilk s\u0131rada yer ald\u0131\u011f\u0131 geleneksel bir i\u00e7erik\u00a0<\/span><strong><span>beyan\u0131<\/span><\/strong><span>\u00a0.\u00a0%1&#8217;i a\u015fan konsantrasyonlarda mevcut olan renkler d\u0131\u015f\u0131ndaki bile\u015fenler azalan s\u0131rada, ard\u0131ndan herhangi bir s\u0131rayla %1 veya daha az konsantrasyonlarda bulunan renk d\u0131\u015f\u0131ndaki bile\u015fenler ve ard\u0131ndan herhangi bir konsantrasyonda mevcut olan renk katk\u0131 maddeleri gelir veya<\/span>\n\n<strong><span>A\u015fa\u011f\u0131dakileri listeleyen alternatif<\/span><\/strong><span>\u00a0bir\u00a0i\u00e7erik beyan\u0131:<\/span>\n\n<span>1. \u00a7 701.3(a) veya \u00a7 701.3(f)&#8217;ye g\u00f6re [%1 veya daha az oranda bulunan bile\u015fenlerin herhangi bir s\u0131rada listelenmesine izin verilir] uyar\u0131nca k\u00fcm\u00fclatif azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re t\u00fcm \u00fcr\u00fcnlerde ortak olan renkler d\u0131\u015f\u0131ndaki i\u00e7erikler\u00a0<\/span><strong><span>,<\/span><\/strong><span>\u00a0ard\u0131ndan\u00a0ile<\/span>\n\n<strong><span>2. T\u00fcm \u00fcr\u00fcnlerde ortak olmayan<\/span><\/strong><span>\u00a0, i\u00e7inde bulunduklar\u0131 \u00fcr\u00fcnlerle tan\u0131mlanan,\u00a0renk d\u0131\u015f\u0131ndaki bile\u015fenler ve ard\u0131ndan<\/span>\n\n<span>3. Bulunduklar\u0131 \u00fcr\u00fcnler belirtilmeden t\u00fcm \u00fcr\u00fcnlerin renk katk\u0131 maddeleri.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Ayn\u0131 Kullan\u0131ma Y\u00f6nelik Benzer \u00dcr\u00fcn \u00c7e\u015fitleri<\/span><\/b>\n\n<span>Mevcut Etiketleme Y\u00fczey Alan\u0131 12 \u0130n\u00e7 Kareden Az<\/span>\n\n<strong><span>Alternatif Beyan<\/span><\/strong>\n\n<strong><span>T\u00fcm bile\u015fenlerin k\u00fcm\u00fclatif azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re tek listesi<\/span><\/strong>\n\n<strong><span>or<\/span><\/strong>\n\n<strong><span>(f) paragraf\u0131na g\u00f6re t\u00fcm bile\u015fenlerin tek listesi<\/span><\/strong>\n\n<strong><span>Benzer bile\u015fime sahip ve etiketleme i\u00e7in toplam y\u00fczey alan\u0131 12 in\u00e7 kareden daha az<\/span><\/strong><span>\u00a0olan bir pakette ayn\u0131 kullan\u0131m i\u00e7in ama\u00e7lanan \u00fcr\u00fcn \u00e7e\u015fitleri,\u00a0\u00f6rne\u011fin kompakt bir kutudaki birka\u00e7 g\u00f6z far\u0131 a\u015fa\u011f\u0131dakilerden birini i\u00e7erebilir:<\/span>\n\n<span>Her bir \u00fcr\u00fcn\u00fcn i\u00e7erik maddelerinin uygun \u00fcr\u00fcn ba\u015fl\u0131klar\u0131 alt\u0131nda tan\u0131mland\u0131\u011f\u0131, t\u00fcm i\u00e7erik maddelerinin azalan s\u0131rada veya \u00a7 701.3(a)&#8217;ya g\u00f6re listelendi\u011fi veya i\u00e7erik maddelerinin \u00a7 701.3(f)&#8217;ye g\u00f6re azalan s\u0131rada ilk s\u0131rada yer ald\u0131\u011f\u0131 listelendi\u011fi geleneksel bir\u00a0<\/span><strong><span>i\u00e7erik<\/span><\/strong><span>\u00a0beyan\u0131\u00a0%1&#8217;i a\u015fan konsantrasyonlarda bulunan renkler d\u0131\u015f\u0131ndaki i\u00e7erik maddelerini, ard\u0131ndan %1 veya daha d\u00fc\u015f\u00fck konsantrasyonlarda bulunan renk d\u0131\u015f\u0131ndaki bile\u015fenleri herhangi bir s\u0131rayla ve ard\u0131ndan herhangi bir konsantrasyonda bulunan renk katk\u0131 maddelerini herhangi bir s\u0131rayla sipari\u015f edin,<\/span>\n\n<span>or<\/span>\n\n<span>T\u00fcm \u00fcr\u00fcnlerin i\u00e7erik maddelerini, \u00a7 701.3(a)&#8217;ya g\u00f6re k\u00fcm\u00fclatif azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re veya \u00a7 701.3(f)&#8217;ye g\u00f6re k\u00fcm\u00fclatif olarak tek bir entegre listede listeleyen\u00a0<\/span><strong><span>alternatif<\/span><\/strong><span>\u00a0bir i\u00e7erik beyan\u0131.<\/span>\n\n<hr \/>\n\n<b><span>Benzer \u00dcr\u00fcn \u00c7e\u015fitleri<\/span><\/b>\n\n<strong><span>G\u00f6z Far\u0131-\u0130ki Ton<\/span><\/strong>\n\n<strong><span>Alternatif Etiketler<\/span><\/strong>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\">\n<thead>\n<tr>\n<th><span>Etiket Kopyalama<\/span><\/th>\n<th><span>Etiketleme Alan\u0131 12 Sq.\u00a0\u0130\u00e7inde.\u00a0yada daha fazla<\/span><\/th>\n<th><span>Etiketleme Alan\u0131 12 Metrekareden Az\u00a0\u0130\u00e7inde.<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td valign=\"top\"><strong><span>Mavi, \u0130nci Rengi:<\/span><\/strong>\n\n<strong><span>Talk<\/span><\/strong>\n\n<strong><span>\u00c7inko Stearat<\/span><\/strong>\n\n<strong><span>Kaolin<\/span><\/strong>\n\n<strong><span>Bentonit<\/span><\/strong>\n\n<strong><span>Mineral ya\u011f<\/span><\/strong>\n\n<strong><span>Bizmut Oksiklor\u00fcr<\/span><\/strong>\n\n<strong><span>Titanyum dioksit<\/span><\/strong>\n\n<strong><span>Lacivert Mavi<\/span><\/strong>\n\n<strong><span>Ultramarin Menek\u015fe<\/span><\/strong>\n\n<strong><span>Ye\u015fil G\u00f6lge:<\/span><\/strong>\n\n<strong><span>Talk<\/span><\/strong>\n\n<strong><span>\u00c7inko Stearat<\/span><\/strong>\n\n<strong><span>Kaolin<\/span><\/strong>\n\n<strong><span>Mineral ya\u011f<\/span><\/strong>\n\n<strong><span>Lanolin<\/span><\/strong>\n\n<strong><span>Titanyum dioksit<\/span><\/strong>\n\n<strong><span>Ultramarin Ye\u015fil<\/span><\/strong>\n\n<strong><span>Krom Hidroksit Ye\u015fil\u00a0<\/span><\/strong><\/td>\n<td valign=\"top\"><strong><span>Talk<\/span><\/strong>\n\n<strong><span>\u00c7inko Stearat<\/span><\/strong>\n\n<strong><span>Kaolin<\/span><\/strong>\n\n<strong><span>Mineral ya\u011f<\/span><\/strong>\n\n<strong><span>Mavi Tonlu Bentonit<\/span><\/strong>\n\n<strong><span>Ye\u015fil G\u00f6lgede Lanolin<\/span><\/strong>\n\n<strong><span>Bizmut Oksiklor\u00fcr<\/span><\/strong>\n\n<strong><span>Titanyum dioksit<\/span><\/strong>\n\n<strong><span>Lacivert Mavi<\/span><\/strong>\n\n<strong><span>Ultramarin Menek\u015fe<\/span><\/strong>\n\n<strong><span>Ultramarin Ye\u015fil<\/span><\/strong>\n\n<strong><span>Krom Hidroksit Ye\u015fil<\/span><\/strong><\/td>\n<td valign=\"top\"><strong><span>Talk<\/span><\/strong>\n\n<strong><span>\u00c7inko Stearat<\/span><\/strong>\n\n<strong><span>Kaolin<\/span><\/strong>\n\n<strong><span>Bentonit<\/span><\/strong>\n\n<strong><span>Mineral ya\u011f<\/span><\/strong>\n\n<strong><span>Lanolin<\/span><\/strong>\n\n<strong><span>Bizmut Oksiklor\u00fcr<\/span><\/strong>\n\n<strong><span>Titanyum dioksit<\/span><\/strong>\n\n<strong><span>Lacivert Mavi<\/span><\/strong>\n\n<strong><span>Ultramarin Menek\u015fe<\/span><\/strong>\n\n<strong><span>Ultramarin Ye\u015fil<\/span><\/strong>\n\n<strong><span>Krom Hidroksit Ye\u015fil<\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<strong><span>21 CFR 701.3(o)(2)\u00a0<\/span><\/strong>\n\n<span>\u0130ki benzer varsay\u0131msal g\u00f6z far\u0131 form\u00fclasyonundan olu\u015fan \u00fcr\u00fcn \u00e7e\u015fidine ili\u015fkin bu \u00f6rnek,\u00a0<\/span><strong><span>12 in\u00e7 kare veya daha fazla (merkez) etiketleme i\u00e7in toplam y\u00fczey alan\u0131na sahip paketler ve\u00a0<\/span><\/strong><strong><span>daha az<\/span><\/strong><span>\u00a0etiketleme i\u00e7in kullan\u0131labilir toplam y\u00fczey alan\u0131na sahip paketler i\u00e7in iste\u011fe ba\u011fl\u0131 i\u00e7erik beyanlar\u0131n\u0131 g\u00f6sterir.\u00a0<strong>12 in\u00e7 kareden<\/strong>\u00a0(sa\u011f taraf) fazla.<\/span>\n\n<strong><span>Sol tarafta<\/span><\/strong><span>\u00a0,\u00a0her biri bir rengi temsil eden iki geleneksel i\u00e7erik beyan\u0131 g\u00f6sterilmektedir.<\/span>\n\n<span>Ortada,\u00a0<\/span><strong><span>12\u00a0<\/span><\/strong><strong><span>in\u00e7 kare veya daha fazla<\/span><\/strong><span>\u00a0kullan\u0131labilir etiketleme alan\u0131na\u00a0sahip paketteki iki renk tonu i\u00e7in entegre i\u00e7erik beyan\u0131 g\u00f6sterilmektedir .\u00a0T\u00fcm \u00fcr\u00fcnlerde ortak olmayan renk d\u0131\u015f\u0131ndaki i\u00e7erik maddelerinin, ortak i\u00e7erik maddelerinden sonra listelendi\u011fini ve kullan\u0131ld\u0131klar\u0131 \u00fcr\u00fcnlerle tan\u0131mland\u0131\u011f\u0131n\u0131 unutmay\u0131n.\u00a0(Mavi G\u00f6lgede Bentonit, Ye\u015fil G\u00f6lgede Lanolin.)<\/span>\n\n<strong><span>Sa\u011f tarafta,<\/span><\/strong><span>\u00a012\u00a0<\/span><strong><span>in\u00e7 kareden daha az<\/span><\/strong><span>\u00a0kullan\u0131labilir etiketleme alan\u0131na\u00a0sahip paketteki iki renk tonu i\u00e7in entegre i\u00e7erik beyan\u0131 g\u00f6sterilmektedir .\u00a0T\u00fcm form\u00fclasyonlarda ortak olmayan bile\u015fenlerin, kullan\u0131ld\u0131klar\u0131 \u00fcr\u00fcnlerle tan\u0131mlanmas\u0131na gerek olmad\u0131\u011f\u0131n\u0131 unutmay\u0131n.<\/span>\n\n<hr \/>\n\n<b><span>Markal\u0131 G\u00f6lge \u00c7izgileri<\/span><a id=\"clgl12\" name=\"clgl12\"><\/a>\n<span>and<\/span>\n<span>Markal\u0131 G\u00f6lgelik \u00c7e\u015fitleri<\/span><\/b>\n\n<strong><span>Tan\u0131m:<\/span><\/strong>\n\n<strong><span>Tek tek paketlenmi\u015f veya ayn\u0131 ad\u0131 ta\u015f\u0131yan g\u00f6z veya y\u00fcz makyaj\u0131 kozmetik \u00fcr\u00fcnleri veya t\u0131rnak cilas\u0131 \u00e7e\u015fitleri<\/span><\/strong>\n\n<strong><span>21 CFR 701.3 (g) (2) ve (o) (3)<\/span>\n<span>(g) (2) ve (o) (4)<\/span><\/strong>\n\n<span>\u00a7\u00a7 701.3(g)(2) ve (o)(3)&#8217;e g\u00f6re, markal\u0131 bir g\u00f6lge serisi, di\u011fer \u015firketlerle payla\u015f\u0131lan bir etiket ta\u015f\u0131yan, ayr\u0131 ayr\u0131 paketlenmi\u015f g\u00f6z veya y\u00fcz makyaj\u0131 kozmetikleri veya t\u0131rnak cilalar\u0131ndan olu\u015fan bir seri olarak tan\u0131mlanabilir. yani ayn\u0131 \u00fcr\u00fcn ad\u0131n\u0131 ta\u015f\u0131yan \u00fcr\u00fcnler.\u00a0\u00d6rnek: Ayn\u0131 markaya sahip bir ruj serisi.<\/span>\n\n<span>\u00a7\u00a7 701.3(g)(2) ve (o)4&#8217;e g\u00f6re, markal\u0131 bir g\u00f6lge \u00e7izgisi \u00e7e\u015fidi, ayn\u0131 etiketi ta\u015f\u0131yan paketlerdeki \u00e7e\u015fitli g\u00f6z veya y\u00fcz makyaj\u0131 kozmetikleri veya t\u0131rnak cilas\u0131 \u00e7e\u015fitleri olarak tan\u0131mlanabilir.\u00a0\u00d6rnek: Her biri birka\u00e7 g\u00f6z far\u0131 i\u00e7eren, ayn\u0131 isim ve etikete sahip birka\u00e7 kompakt.<\/span>\n\n<span>701.3(g)(2) ve (o)(4)&#8217;e g\u00f6re markal\u0131 renk \u00e7izgisi \u00e7e\u015fitleri, ayn\u0131 etiketi ta\u015f\u0131yan paketler i\u00e7indeki \u00e7e\u015fitli g\u00f6z veya y\u00fcz makyaj\u0131 kozmetikleri veya t\u0131rnak cilas\u0131 \u00e7e\u015fitleri olarak tan\u0131mlanabilir.\u00a0\u00d6rnek: Her biri birka\u00e7 g\u00f6z far\u0131 i\u00e7eren, ayn\u0131 isim ve etikete sahip birka\u00e7 kompakt.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Markal\u0131 G\u00f6lge \u00c7izgileri<\/span>\n<span>and<\/span>\n<span>Markal\u0131 G\u00f6lge \u00c7izgisi \u00c7e\u015fitleri<\/span><\/b>\n\n<strong><span>Alternatif Beyan<\/span><\/strong>\n\n<strong><span>T\u00fcm markal\u0131 renk tonlar\u0131 i\u00e7in tek i\u00e7erik beyan\u0131 listeleniyor&#8230;<\/span><\/strong>\n<ol>\n \t<li><strong><span>T\u00fcm \u00fcr\u00fcnlerde ortak olan i\u00e7erikler, k\u00fcm\u00fclatif azalan a\u011f\u0131rl\u0131k s\u0131ras\u0131na g\u00f6re<\/span><\/strong><\/li>\n \t<li><strong><span>Yayg\u0131n olmayan, kullan\u0131ld\u0131\u011f\u0131 \u00fcr\u00fcne g\u00f6re tan\u0131mlanan i\u00e7erikler<\/span><\/strong><\/li>\n \t<li><strong><span>T\u00fcm \u00fcr\u00fcnlerde ortak olan renk katk\u0131 maddeleri herhangi bir s\u0131rayla<\/span><\/strong><\/li>\n \t<li><strong><span>Renk katk\u0131 maddeleri yayg\u0131n de\u011fildir, \u00f6n\u00fcnde &#8220;\u0130\u00e7erebilir&#8221; ibaresi bulunur<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR 701.3 (g) (2) ve (o) (3)<\/span>\n<span>(g) (2) ve (o) (4)<\/span><\/strong>\n\n<span>Markal\u0131 g\u00f6lge \u00e7izgileri ve markal\u0131 g\u00f6lge \u00e7izgisi \u00e7e\u015fitleri a\u015fa\u011f\u0131dakilerden birini ta\u015f\u0131yabilir:<\/span>\n\n<span>Her bir \u00fcr\u00fcn\u00fcn bile\u015fenlerinin, \u00a7 701.3(a)&#8217;ya g\u00f6re veya alternatif olarak \u00a7 701.3(f)&#8217;ye g\u00f6re azalan \u00f6ncelik s\u0131ras\u0131na g\u00f6re tan\u0131mland\u0131\u011f\u0131, her bir \u00fcr\u00fcn i\u00e7in geleneksel bir\u00a0<\/span><strong><span>i\u00e7erik<\/span><\/strong><span>\u00a0beyan\u0131 [\u00e7e\u015fitli olmas\u0131 durumunda i\u00e7erik maddeleri farkl\u0131 olabilir \u00a7\u00a7 701.3(a) veya (f)&#8217;ye g\u00f6re her \u00e7e\u015fit i\u00e7in tek bir listede k\u00fcm\u00fclatif olarak beyan edilir]<\/span>\n\n<span>or<\/span>\n\n<span>T\u00fcm markal\u0131 tonlar i\u00e7in t\u00fcm i\u00e7erik maddelerini a\u015fa\u011f\u0131da g\u00f6sterilen k\u00fcm\u00fclatif s\u0131rayla listeleyen\u00a0<\/span><strong><span>alternatif<\/span><\/strong><span>\u00a0bir i\u00e7erik beyan\u0131.\u00a0Bu durumda, markal\u0131 bir renk serisinin her tonu veya markal\u0131 bir renk tonu serisinin her paketi ayn\u0131 i\u00e7erik beyan\u0131n\u0131 ta\u015f\u0131r.<\/span>\n\n<hr \/>\n\n<b><span>Markal\u0131 G\u00f6lge \u00c7izgileri ve Markal\u0131 G\u00f6lge \u00c7izgisi \u00c7e\u015fitleri<\/span><\/b>\n\n<span>Ruj &#8211; Kiraz K\u0131rm\u0131z\u0131s\u0131<\/span>\n<div class=\"table-responsive\">\n<table class=\"table table-bordered\" summary=\"layout\">\n<tbody>\n<tr>\n<td valign=\"top\"><strong><span>Yanl\u0131\u015f Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>Hint Ya\u011f\u0131<\/span><\/strong>\n\n<strong><span>Izopropil miristat<\/span><\/strong>\n\n<strong><span>Balmumu<\/span><\/strong>\n\n<strong><span>Kandelilla Balmumu<\/span><\/strong>\n\n<strong><span>Oleyl Alkol<\/span><\/strong>\n\n<strong><span>Ozokerit<\/span><\/strong>\n\n<strong><span>Sorbitan Trioleat<\/span><\/strong>\n\n<strong><span>\u0130\u00e7erebilir:<\/span><\/strong>\n\n<strong><span>Mika (ve) Titanyum Dioksit (ve) Demir Oksitler<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No.21<\/span><\/strong>\n\n<strong><span>D&amp;C Turuncu No.5<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No. 6 Baryum G\u00f6l\u00fc<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No. 7 Kalsiyum G\u00f6l\u00fc<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No. 27 Al\u00fcminyum Lake<\/span><\/strong>\n\n<strong><span>D&amp;C Orange No. 5 Al\u00fcminyum Lake<\/span><\/strong>\n\n<strong><span>D&amp;C Sar\u0131 No. 10 Al\u00fcminyum Lake<\/span><\/strong><\/td>\n<td><strong><span>Do\u011fru Etiket Kopyas\u0131:<\/span><\/strong>\n\n<strong><span>Hint Ya\u011f\u0131<\/span><\/strong>\n\n<strong><span>Izopropil miristat<\/span><\/strong>\n\n<strong><span>Balmumu<\/span><\/strong>\n\n<strong><span>Kandelilla Balmumu<\/span><\/strong>\n\n<strong><span>Oleyl Alkol<\/span><\/strong>\n\n<strong><span>Ozokerit<\/span><\/strong>\n\n<strong><span>\u0130nci \u015eeftali ve \u0130nci Kiraz Tonlar\u0131nda Sorbitan Trioleat<\/span><\/strong>\n\n<strong><span>Titanyum dioksit<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No.21<\/span><\/strong>\n\n<strong><span>D&amp;C Turuncu No.5<\/span><\/strong>\n\n<strong><span>\u0130\u00e7erebilir:<\/span><\/strong>\n\n<strong><span>Mika<\/span><\/strong>\n\n<strong><span>Demir oksitler<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No. 6 Baryum G\u00f6l\u00fc<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No. 7 Kalsiyum G\u00f6l\u00fc<\/span><\/strong>\n\n<strong><span>D&amp;C K\u0131rm\u0131z\u0131 No. 27 Al\u00fcminyum Lake<\/span><\/strong>\n\n<strong><span>D&amp;C Orange No. 5 Al\u00fcminyum Lake<\/span><\/strong>\n\n<strong><span>D&amp;C Sar\u0131 No. 10 Al\u00fcminyum Lake<\/span><\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span>Ayn\u0131 marka ad\u0131n\u0131 ta\u015f\u0131yan bir ruj serisinin varsay\u0131msal renk tonuna ili\u015fkin bu \u00f6rnek, kozmetik i\u00e7erik beyanlar\u0131nda bulunan \u00fc\u00e7 yayg\u0131n hatay\u0131 g\u00f6stermektedir:<\/span>\n\n<span>1. \u0130\u00e7erik s\u00f6zl\u00fc\u011f\u00fcnde parantez i\u00e7inde &#8220;(ve)&#8221; ile tan\u0131mlanan bile\u015fenlerin tescilli kar\u0131\u015f\u0131mlar\u0131, genellikle kimyasal\/ticari adlar\u0131 ve bunlar\u0131n ilgili etiket adlar\u0131n\u0131 listeleyen s\u00f6zl\u00fck b\u00f6l\u00fcm\u00fcnde g\u00f6sterildi\u011fi gibi etiket \u00fczerinde beyan edilir.\u00a0Bu t\u00fcr kar\u0131\u015f\u0131mlar\u0131n bile\u015fikleri ayr\u0131lmal\u0131, &#8220;(ve)&#8221; atlanmal\u0131 ve bile\u015fenler, etiketleme amac\u0131yla ayr\u0131 ayr\u0131 bile\u015fenler olarak ele al\u0131nmal\u0131d\u0131r.\u00a0Bkz. &#8220;Mika (ve) Titanyum dioksit (ve) Demir oksitler.&#8221;<\/span>\n\n<span>2. Bir\u00e7ok etiket, bir g\u00f6lge \u00e7izgisinin t\u00fcm renk katk\u0131 maddelerini &#8220;\u0130\u00e7erebilir&#8221; ifadesinden sonra listeler.\u00a0T\u00fcm tonlarda ortak olan renk katk\u0131 maddeleri &#8220;\u0130\u00e7erebilir&#8221; ifadesinden \u00f6nce listelenmelidir ve yaln\u0131zca t\u00fcm renk form\u00fclasyonlar\u0131nda\u00a0<\/span><strong><span>bulunmayanlar<\/span><\/strong><span>\u00a0&#8220;\u0130\u00e7erebilir&#8221; ifadesinden sonra listelenebilir.<\/span>\n\n<span>3. Renklerin d\u0131\u015f\u0131ndaki t\u00fcm renk form\u00fclasyonlar\u0131nda yer almayan bile\u015fenler, mevcut olduklar\u0131 renk tonlar\u0131na g\u00f6re tan\u0131mlanmal\u0131d\u0131r.<\/span>\n\n<hr \/>\n\n<b><span>Do\u011frudan Posta Kozmetikleri<\/span><a id=\"clgl13\" name=\"clgl13\"><\/a><\/b>\n\n<strong><span>Description<\/span><\/strong>\n\n<strong><span>Arac\u0131 bir sat\u0131\u015f temsilcisinin kat\u0131l\u0131m\u0131 olmadan posta yoluyla t\u00fcketicilere sipari\u015f edilen ve t\u00fcketicilere teslim edilen kozmetikler<\/span><\/strong>\n\n<strong><span>21 CFR 701.3 (r)<\/span><\/strong>\n\n<span>Do\u011frudan postayla g\u00f6nderilen kozmetik \u00fcr\u00fcnleri, bir bilgi panelindeki i\u00e7erik beyan\u0131na alternatif olarak paket d\u0131\u015f\u0131 i\u00e7erik etiketlemesini kullanabilir.<\/span>\n\n<span>Kozmetik i\u00e7erik etiketlemesi amac\u0131yla, do\u011frudan postayla sat\u0131lan kozmetikler, posta yoluyla sipari\u015f edilen ve arac\u0131 bir sat\u0131\u015f temsilcisinin kat\u0131l\u0131m\u0131 olmadan t\u00fcketicilere posta yoluyla teslim edilen kozmetikler olarak tan\u0131mlan\u0131r.<\/span>\n\n<span>T\u00fcketicilere &#8220;kap\u0131dan kap\u0131ya&#8221; sat\u0131\u015f g\u00f6revlileri arac\u0131l\u0131\u011f\u0131yla sat\u0131lan kozmetikler, t\u00fcketicilere do\u011frudan posta yoluyla teslim edilebilseler bile, do\u011frudan postayla g\u00f6nderilen kozmetik \u00fcr\u00fcnleri olarak kabul edilmez.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Do\u011frudan Posta Kozmetikleri<\/span><\/b>\n\n<strong><span>Hakk\u0131nda Bildiri<\/span><\/strong>\n\n<strong><span>postayla g\u00f6nderilen kozmetik \u00fcr\u00fcn\u00fcne e\u015flik eden etiketleme<\/span><\/strong>\n\n<strong><span>or<\/span><\/strong>\n\n<strong><span>posta yoluyla kozmetik sipari\u015fi veren her t\u00fcketiciye sa\u011flanan etiketleme<\/span><\/strong>\n\n<strong><span>21 CFR 701.3 (r)<\/span><\/strong>\n\n<span>Bir bilgi panelindeki i\u00e7erik beyan\u0131na alternatif olarak beyan, y\u00fcksekli\u011fi 1\/16 in\u00e7ten az olmayan harflerle \u015fu \u015fekilde g\u00f6r\u00fcnebilir:<\/span>\n\n<span>Postalanan kozmetik \u00fcr\u00fcnlerine e\u015flik eden ve \u00f6zellikle bunlarla ilgili olan etiketler; \u00f6rne\u011fin bir bro\u015f\u00fcr, ek veya g\u00fcvenli kullan\u0131m i\u00e7in yaz\u0131l\u0131 talimatlar veya<\/span>\n\n<span>Her t\u00fcketiciye ki\u015fisel kullan\u0131m i\u00e7in sa\u011flanan ve kozmetik \u00fcr\u00fcnlerinin posta yoluyla sipari\u015f edildi\u011fi etiketleme, \u00f6rne\u011fin do\u011frudan postayla sat\u0131\u015f katalo\u011fu veya bro\u015f\u00fcr\u00fc.<\/span>\n\n<hr \/>\n\n<b><span>Do\u011frudan Posta Kozmetikleri<\/span><\/b>\n\n<strong><span>Gereksinimler<\/span><\/strong>\n\n<strong><span>Paketin \u00fcst\u00fcne, i\u00e7ine veya d\u0131\u015f\u0131na yerle\u015ftirilen veya yap\u0131\u015ft\u0131r\u0131lan 3\/16 in\u00e7lik harflerle yaz\u0131lm\u0131\u015f \u015fu bildirim:<\/span><\/strong>\n<ol>\n \t<li><strong><span>\u0130\u00e7erik beyan\u0131n\u0131n yeri<\/span><\/strong><\/li>\n \t<li><strong><span>Talep \u00fczerine posta yoluyla temin edilebilir<\/span><\/strong><\/li>\n \t<li><strong><span>Distrib\u00fct\u00f6r\u00fcn ad\u0131 ve adresi<\/span><\/strong><\/li>\n<\/ol>\n<strong><span>21 CFR 701.3(r)<\/span><\/strong>\n\n<span>T\u00fcketicilere do\u011frudan posta yoluyla da\u011f\u0131t\u0131lan kozmetik i\u00e7eriklerinin paket d\u0131\u015f\u0131 etiketleme yoluyla sunulmas\u0131 durumunda a\u015fa\u011f\u0131daki gereklili\u011fin kar\u015f\u0131lanmas\u0131 gerekir:<\/span>\n\n<span>1. T\u00fcketicilere g\u00f6nderilen pakete, t\u00fcketiciye i\u00e7indekiler beyan\u0131n\u0131n\/beyannamelerinin yerini, postayla sipari\u015f da\u011f\u0131t\u0131c\u0131s\u0131n\u0131n ad\u0131n\u0131 ve adresini ve bir kopyas\u0131n\u0131n g\u00f6nderildi\u011fini bildiren 3\/16 in\u00e7lik yaz\u0131yla birlikte bir bildirim eklenmelidir. \u0130\u00e7erik beyan(lar)\u0131 talep eden herkese postayla g\u00f6nderilecektir.<\/span>\n\n<span>2. Postayla sipari\u015f da\u011f\u0131t\u0131c\u0131s\u0131, i\u00e7erik beyan\u0131n\u0131n bir kopyas\u0131n\u0131 talep eden ki\u015fiye derhal postalamal\u0131d\u0131r.<\/span>\n\n<span>3. 3\/16 in\u00e7lik harflerle yaz\u0131lan bildirim paketin \u00fcst k\u0131sm\u0131nda yer almal\u0131 veya \u00fczerine yap\u0131\u015ft\u0131r\u0131lmal\u0131d\u0131r;\u00a0veya paketin i\u00e7inde, i\u00e7eri\u011fin \u00fcst\u00fcnde veya \u00fcr\u00fcn\u00fc\/\u00fcr\u00fcnleri \u00e7evreleyen ve tutan platformun \u00f6n y\u00fcz\u00fcnde olmal\u0131 ve a\u00e7\u0131ld\u0131\u011f\u0131nda t\u00fcketici taraf\u0131ndan kolayca g\u00f6r\u00fclebilmelidir.<\/span>\n\n<span>4. \u0130\u00e7erik beyanlar\u0131 dikkat \u00e7ekici olmal\u0131 ve t\u00fcketicinin her bir i\u00e7erik beyan\u0131n\u0131 her bir kozmetik \u00fcr\u00fcnle kolayca ili\u015fkilendirebilmesini sa\u011flayacak \u015fekilde sunulmal\u0131d\u0131r.<\/span>\n\n<hr \/>\n\n<b><span>Paket D\u0131\u015f\u0131 \u0130\u00e7erik Etiketlemesi<\/span><a id=\"clgl14\" name=\"clgl14\"><\/a>\n<span>Yeterlilik Ko\u015fullar\u0131<\/span><\/b>\n<div><span tabindex=\"-1\" contenteditable=\"false\"><img decoding=\"async\" class=\"img-responsive\" src=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide\" alt=\"\" data-widget=\"image\" \/><\/span><span tabindex=\"-1\" contenteditable=\"false\"><img decoding=\"async\" src=\"https:\/\/www.fda.gov\/media\/76632\/download\" alt=\"Ak\u0131\u015f \u015eemas\u0131: Paket D\u0131\u015f\u0131 \u0130\u00e7erik Etiketleme Gereksinimleri\" data-widget=\"image\" \/><\/span><\/div>\n<strong><span>21 CFR 701.3(i)<\/span><\/strong>\n\n<span>Bir kozmetik \u00fcr\u00fcne e\u015flik eden etiketlemedeki i\u00e7erik beyan\u0131, yani ambalaj d\u0131\u015f\u0131 i\u00e7erik etiketlemesi \u015funlar\u0131 gerektirir:<\/span>\n\n<span>(1)\u00dcr\u00fcn bir d\u0131\u015f kap i\u00e7ine konmam\u0131\u015ft\u0131r,<\/span>\n\n<span>(2)Toplam paket y\u00fczey alan\u0131 12 in\u00e7 kareden azd\u0131r ve<\/span>\n\n<span>(3) \u00dcr\u00fcnler, s\u0131k\u0131 b\u00f6lmelere sahip tepsi veya raflarda sat\u0131\u015fa sunulur.<\/span>\n\n<span>\u0130\u00e7erik beyan\u0131 y\u00fcksekli\u011fi 1\/16 in\u00e7ten az olmayan harflerle yaz\u0131lmal\u0131d\u0131r ve \u00fcr\u00fcnle birlikte verilen yast\u0131kl\u0131 sayfalarda, bro\u015f\u00fcrlerde veya benzer etiketlerde yer alabilir.<\/span>\n\n<strong><span>G\u00f6z veya y\u00fcz makyaj\u0131 kozmeti\u011fi veya t\u0131rnak cilas\u0131 olmayan<\/span><\/strong><span>\u00a0\u00fcr\u00fcnler,\u00a0sat\u0131\u015f i\u00e7in s\u0131k\u0131 b\u00f6lmelere sahip tepsiler veya bir te\u015fhir \u00fcnitesinin raflar\u0131nda sergilenmelidir.\u00a0\u0130\u00e7erik beyan\u0131n\u0131\/beyanlar\u0131n\u0131 ta\u015f\u0131yan yast\u0131kl\u0131 sayfalar\u0131n veya bro\u015f\u00fcrlerin tutucusu te\u015fhir \u00fcnitesine tak\u0131lmal\u0131d\u0131r.<\/span>\n\n<strong><span>G\u00f6z veya y\u00fcz makyaj\u0131 kozmetikleri veya t\u0131rnak cilalar\u0131 olan<\/span><\/strong><span>\u00a0\u00fcr\u00fcnler,\u00a0sat\u0131\u015f tezgah\u0131n\u0131n alt\u0131na yerle\u015ftirilen, s\u0131k\u0131 b\u00f6lmelere sahip tepsi veya raflarda sat\u0131\u015fa sunulabilir.\u00a0\u0130\u00e7erik etiketinin sahibi, \u00fcr\u00fcn renklerinin \u00f6rneklerini ta\u015f\u0131yan ve al\u0131c\u0131lara g\u00f6sterilen bir sergi tablosuna ili\u015ftirilmelidir.<\/span>\n\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide#top\" rel=\"nofollow noopener\" target=\"_blank\"><span>ba\u015fa d\u00f6n\u00fc\u015f<\/span><\/a>\n\n<hr \/>\n\n<b><span>Paket D\u0131\u015f\u0131 \u0130\u00e7erik Etiketlemesi<\/span><\/b>\n\n<strong><span>Etiketleme Sahibi<\/span><\/strong>\n\n<strong><span>1. Son liste al\u0131nd\u0131ktan sonra a\u015fa\u011f\u0131daki ifadeyi g\u00f6r\u00fcn\u00fcr \u015fekilde ta\u015f\u0131mal\u0131d\u0131r:<\/span>\n<span>&#8220;Federal yasa, i\u00e7indekiler listesinin burada g\u00f6r\u00fcnt\u00fclenmesini gerektirir.&#8221;\u00a0<\/span><\/strong>\n\n<strong><span>21.CFR 701.3(j)<\/span><\/strong>\n\n<span>Bir bilgi panelindeki i\u00e7erik beyan\u0131na alternatif olarak paket d\u0131\u015f\u0131 i\u00e7erik etiketlemesi kullan\u0131l\u0131yorsa, \u00a7\u00a7 701.3(j) ve (k)&#8217;de a\u00e7\u0131klanan \u00e7e\u015fitli ko\u015fullar aras\u0131nda a\u015fa\u011f\u0131dakilere \u00f6zellikle dikkat edilmelidir:<\/span>\n\n<span>1. Te\u015fhir \u00fcnitesi veya \u015femas\u0131, y\u00fcksekli\u011fi bir in\u00e7in 3\/16&#8217;s\u0131ndan az olmayan harflerle &#8220;Federal yasa, i\u00e7erik listelerinin burada g\u00f6r\u00fcnt\u00fclenmesini gerektirir&#8221; ifadesini ta\u015f\u0131mal\u0131d\u0131r.\u00a0Bu ifade, son i\u00e7erik listesi al\u0131nd\u0131\u011f\u0131nda dikkat \u00e7ekici hale gelir veya i\u00e7erik beyan\u0131n\u0131\/beyanlar\u0131n\u0131 ta\u015f\u0131yan etiket sahibinin yan\u0131nda her zaman g\u00f6sterilebilir.<\/span>\n\n<hr \/>\n\n<b><span>Paket D\u0131\u015f\u0131 \u0130\u00e7erik Etiketlemesi<\/span><\/b>\n\n<strong><span>Etiketleme Sahibi<\/span><\/strong>\n\n<strong><span>2. Dolgulu \u00e7ar\u015faflar veya bro\u015f\u00fcrler te\u015fhir \u00fcnitesine ili\u015ftirilmeli ve \u00f6n taraftan tamamen g\u00f6r\u00fclebilmelidir.<\/span><\/strong>\n\n<strong><span>or<\/span><\/strong>\n\n<strong><span>\u00f6n tarafta k\u0131smen g\u00f6r\u00fcn\u00fcr ve 3\/16 in\u00e7lik harflerle konumlar\u0131n\u0131 a\u00e7\u0131klayan bir uyar\u0131 bulunur<\/span><\/strong>\n\n<strong><span>or<\/span><\/strong>\n\n<strong><span>yaln\u0131zca yan tarafta bulunur ve konum bildirimini ta\u015f\u0131r.<\/span><\/strong>\n\n<strong><span>21 CFR 701.3 (j)<\/span><\/strong>\n\n<span>2. Ambalaj d\u0131\u015f\u0131 kozmetik i\u00e7erik etiketi tutucusu, \u00f6rne\u011fin yast\u0131kl\u0131 sayfalar veya bro\u015f\u00fcrler, etiketin te\u015fhir \u00fcnitesinin veya tablonun \u00f6n\u00fcnde olmas\u0131 ve al\u0131c\u0131 taraf\u0131ndan tam olarak okunabilmesi i\u00e7in te\u015fhir \u00fcnitesine veya tabloya ili\u015ftirilmelidir. Perakende sat\u0131\u015f\u0131n al\u0131\u015f\u0131lagelmi\u015f ko\u015fullar\u0131 alt\u0131nda te\u015fhire d\u00f6n\u00fck olarak.<\/span>\n\n<span>Paket d\u0131\u015f\u0131 i\u00e7erik etiketlemesinin tam olarak g\u00f6r\u00fcnt\u00fclenmesine alternatif olarak etiketleme, te\u015fhir \u00fcnitesinin veya tablonun yan taraf\u0131nda da olabilir, ancak \u00fcstte, arkada veya altta olamaz; bu durumda, etikette dikkat \u00e7ekici bir uyar\u0131n\u0131n e\u015flik etmesi gerekir. Te\u015fhir \u00fcnitesinin \u00f6n taraf\u0131nda, ambalaj d\u0131\u015f\u0131 etiketin yerini a\u00e7\u0131klayan ve &#8220;Federal yasa, i\u00e7erik listelerinin burada g\u00f6r\u00fcnt\u00fclenmesini gerektirir&#8221; ifadesini i\u00e7eren 3\/16 in\u00e7lik yaz\u0131.<\/span>\n\n<hr \/>\n\n<b><span>Ek gereksinimler<\/span><\/b>\n\n<strong><span>1. Bro\u015f\u00fcrlerde te\u015fhir \u00fcnitesi veya tabloyla birlikte sat\u0131lan t\u00fcm \u00fcr\u00fcnlerin beyanlar\u0131 bulunmal\u0131d\u0131r.<\/span><\/strong>\n\n<strong><span>2. Bro\u015f\u00fcrler ayn\u0131 olmal\u0131d\u0131r.<\/span><\/strong>\n\n<strong><span>21 CFR 701.3(k)<\/span><\/strong>\n\n<span>Kozmetiklerin ambalaj d\u0131\u015f\u0131 i\u00e7erik etiketlemesi gerekliliklerine uymak i\u00e7in a\u015fa\u011f\u0131daki ek ko\u015fullar\u0131n kar\u015f\u0131lanmas\u0131 gerekir:<\/span>\n\n<span>1. Te\u015fhir \u00fcnitesine veya tabloya ili\u015ftirilen yast\u0131kl\u0131 sayfalar veya bro\u015f\u00fcrler, te\u015fhirle birlikte sat\u0131lan t\u00fcm \u00fcr\u00fcnlerin i\u00e7eri\u011fini beyan etmelidir.<\/span>\n\n<span>2. Yast\u0131kl\u0131 \u00e7ar\u015faflar veya bro\u015f\u00fcrler ayn\u0131 olmal\u0131d\u0131r.<\/span>\n\n<hr \/>\n\n<b><span>Ek gereksinimler<\/span><\/b>\n\n<strong><span>3. Bro\u015f\u00fcrler ve g\u00f6rseller birlikte g\u00f6nderilmelidir.<\/span><\/strong>\n\n<strong><span>4. Bro\u015f\u00fcrlerin say\u0131s\u0131 yeterli olmal\u0131 ve sat\u0131c\u0131ya de\u011fi\u015ftirme talimatlar\u0131n\u0131 i\u00e7eren yedeklerle de\u011fi\u015ftirilmelidir.<\/span><\/strong>\n\n<strong><span>21 CFR 701.3<\/span><\/strong>\n\n<span>3. Bir kozmetik \u00fcr\u00fcn\u00fcn\u00fcn her sevkiyat\u0131 ile birlikte sa\u011flanan yast\u0131kl\u0131 sayfa veya bro\u015f\u00fcrlerin kopya say\u0131s\u0131, her al\u0131c\u0131n\u0131n i\u00e7erik beyan\u0131n\u0131n bir kopyas\u0131n\u0131 alabilmesi i\u00e7in yeterli olmal\u0131d\u0131r.\u00a0Ayr\u0131ca, perakendecilerin yast\u0131kl\u0131 \u00e7ar\u015faflar\u0131 veya bro\u015f\u00fcrleri te\u015fhir etmesini sa\u011flamak i\u00e7in te\u015fhir \u00fcniteleri ve yedek etiketler, perakendeciye uygun talimatlarla birlikte verilmelidir.<\/span>\n\n<span>4. Yeniden doldurulan \u00f6\u011felerin g\u00f6nderilerine ayr\u0131ca i\u00e7erik beyanlar\u0131n\u0131n yeterli say\u0131da kopyas\u0131 da eklenmeli ve yeniden doldurulan \u00f6\u011felerin bulundu\u011fu kap ve i\u00e7erik bildirimlerinin ilgili kopyalar\u0131 ba\u015fka kozmetik \u00fcr\u00fcnler i\u00e7ermemelidir.<\/span>\n\n<hr \/>\n\n<b><span>Ek gereksinimler<\/span><\/b>\n\n<strong><span>5. Etiket firmas\u0131, i\u00e7erik beyan\u0131n\u0131n bir kopyas\u0131n\u0131 talep eden ki\u015fiye g\u00f6ndermelidir.<\/span><\/strong>\n\n<strong><span>6. Form\u00fcl de\u011fi\u015fikli\u011fi durumunda kullanma talimat\u0131nda her iki form\u00fclasyon da belirtilmelidir.<\/span><\/strong>\n\n<strong><span>21 CFR 701.3<\/span><\/strong>\n\n<span>5. Ambalaj d\u0131\u015f\u0131 kozmetik i\u00e7erik etiketlemesi yapan firma, i\u00e7erik beyan\u0131n\u0131n bir kopyas\u0131n\u0131 talep eden ki\u015fiye derhal postalamal\u0131d\u0131r.<\/span>\n\n<span>6. Form\u00fcl de\u011fi\u015fikli\u011fi durumunda, te\u015fhir \u00fcnitesi veya tabloyla birlikte g\u00f6nderilmiyorsa yeni yast\u0131kl\u0131 sayfa veya bro\u015f\u00fcre tarih at\u0131lmal\u0131d\u0131r.\u00a0Eski ve yeni form\u00fclasyonlarla birlikte yast\u0131kl\u0131 bir sayfa veya kullanma talimat\u0131 kullan\u0131lacaksa, her iki i\u00e7erik beyan\u0131n\u0131 da ta\u015f\u0131mal\u0131d\u0131r ve beyanlar, al\u0131c\u0131n\u0131n hangi beyan\u0131n hangi \u00fcr\u00fcne ait oldu\u011funu belirleyebilece\u011fi \u015fekilde tan\u0131mlanmal\u0131d\u0131r.\u00a0Alternatif olarak, iki i\u00e7erik beyan\u0131n\u0131 ta\u015f\u0131yan yast\u0131kl\u0131 sayfa veya kullanma talimat\u0131, al\u0131c\u0131ya form\u00fclasyonun de\u011fi\u015ftirildi\u011fi ve her iki beyan\u0131n da ge\u00e7erli olabilece\u011fi konusunda bilgi verebilir.<\/span>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5fcff34 e-flex e-con-boxed e-con e-parent\" data-id=\"5fcff34\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-93b9905 elementor-widget elementor-widget-text-editor\" data-id=\"93b9905\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tSource: <a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.fda.gov\/cosmetics\/cosmetics-labeling-regulations\/cosmetics-labeling-guide<\/a>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>PDF format\u0131nda mevcut\u00a0(316KB) Kozmetik Etiketleme K\u0131lavuzu, \u00fcreticilerin ABD yasalar\u0131 ve ilgili d\u00fczenlemeler kapsam\u0131ndaki etiketleme gereklilikleri hakk\u0131nda s\u0131kl\u0131kla sordu\u011fu sorular\u0131n \u00f6rnekleri ve yan\u0131tlar\u0131yla birlikte, kozmetik etiketlemeyle ilgili ad\u0131m ad\u0131m yard\u0131m sa\u011flar. Bu sayfada: Kozmetik Etiketlemeyi D\u00fczenleyen Kanunlar Terimlerin Yasal Tan\u0131mlar\u0131 Ana G\u00f6sterge Paneli Bilgilerin Etiketler \u00dczerine Yerle\u015ftirilmesi \u00d6ne \u00c7\u0131kma ve G\u00f6ze \u00c7arpma Dil Tip Boyut Kimlik&#8230;<\/p>","protected":false},"featured_media":991213,"parent":0,"template":"","amerikada-yasal-duzenlemeler-kat":[280],"class_list":["post-991212","amerikada-yasal-duze","type-amerikada-yasal-duze","status-publish","has-post-thumbnail","hentry","amerikada-yasal-duzenlemeler-kat-amerikada-kozmetik-sektoru-yasal-duzenlemeleri"],"acf":[],"_links":{"self":[{"href":"https:\/\/lonca.com\/en\/wp-json\/wp\/v2\/amerikada-yasal-duze\/991212","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lonca.com\/en\/wp-json\/wp\/v2\/amerikada-yasal-duze"}],"about":[{"href":"https:\/\/lonca.com\/en\/wp-json\/wp\/v2\/types\/amerikada-yasal-duze"}],"version-history":[{"count":4,"href":"https:\/\/lonca.com\/en\/wp-json\/wp\/v2\/amerikada-yasal-duze\/991212\/revisions"}],"predecessor-version":[{"id":991218,"href":"https:\/\/lonca.com\/en\/wp-json\/wp\/v2\/amerikada-yasal-duze\/991212\/revisions\/991218"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lonca.com\/en\/wp-json\/wp\/v2\/media\/991213"}],"wp:attachment":[{"href":"https:\/\/lonca.com\/en\/wp-json\/wp\/v2\/media?parent=991212"}],"wp:term":[{"taxonomy":"amerikada-yasal-duzenlemeler-kat","embeddable":true,"href":"https:\/\/lonca.com\/en\/wp-json\/wp\/v2\/amerikada-yasal-duzenlemeler-kat?post=991212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}