Current status of the sunscreen regulation in the United States: 2011 Food and Drug Administration's final rule on labeling and effectiveness testing.

Wang SQ; Lim HW

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Current status of the sunscreen regulation in the United States: 2011 Food and Drug Administration's final rule on labeling and effectiveness testing.

机译：美国防晒法规的现状：2011年美国食品药品监督管理局（FDA）关于标签和功效测试的最终规则。

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On June 17, 2011, the US Food and Drug Administration (FDA) issued its long awaited final ruling on labeling and effectiveness testing of sunscreen products in the United States.1 At the same time, the FDA published 3 other documents: (1) a Draft Enforcement Guidance for Industry document, further explaining the final rule,2 (2) a Proposed Rule on sunscreens with sun protection factors (SPFs) greater than 50, seeking additional comments on its proposal to cap SPF at 50+,3 and (3) an Advance Notice of Proposed Rulemaking (ANPR), requesting information about alternative dosage forms of sunscreen products (ie, sprays), and proposing that certain dosage forms (wipes, towelettes, powders, body washes, and shampoos) to be considered not eligible for review under the sunscreen monograph process.

机译：2011年6月17日，美国食品药品监督管理局（FDA）发布了期待已久的美国防晒产品标签和有效性测试的最终裁决。1同时，FDA还发布了其他三份文件：（1）一份《工业指导指南草案》，进一步解释了最终规则2（2）关于防晒系数（SPFs）大于50的防晒霜的拟议规则，寻求对其SPF上限为50 +，3的提案的其他评论，以及（ 3）拟议规则制定的预先通知（ANPR），要求获得有关防晒产品（例如喷雾剂）替代剂型的信息，并提出不应考虑某些剂型（湿巾，毛巾，粉剂，沐浴露和洗发剂）有资格接受防晒专着审查。

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《Journal of the American Academy of Dermatology》 |2011年第4期|共7页
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Wang SQ; Lim HW;
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中图分类皮肤病学与性病学;
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1. Current status of the sunscreen regulation in the United States: 2011 Food and Drug Administration's final rule on labeling and effectiveness testing. [J] . Wang SQ, Lim HW Journal of the American Academy of Dermatology . 2011,第4期

机译：美国防晒法规的现状：2011年美国食品药品监督管理局（FDA）关于标签和功效测试的最终规则。
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3. The FDA final rule on labeling and effectiveness testing of sunscreens: Too little, too late? [J] . DiffeyB. Journal of the American Academy of Dermatology . 2012,第1期

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6. Do drug package inserts meet the rules and regulations of Iran’s Food and Drug Administration in terms of informing patients? [O] . Tahereh Eteraf-Oskouei, Saeid Abdollahpour, Moslem Najafi, 2019

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7. Proposal for a COUNCIL REGULATION (EEC)laying down general rules for the supply of butter oil to the Office ofthe United Nations High Commissioner for Refugees for certain sectionsof the population in Cyprus under the 1977 food-aid programme Proposal for aCOUNCIL REGULATION (EEC)·on the supply of skimmed-milk powder to the Office of the United NationsHigh Commissioner for Refugees for certain sections of the population inCyprus as emergency food aid pursuant to Regulation (EEC) No 1299/76 Proposal for aCOUNCIL REGULATION (EEC)on the Community financing of certain costs in respect of the food aid inthe form of cereals allocated under the 1974/75 programme to the Officeof the United Nations Nigh Commissioner for Refugees for certain sectionsof the population in Cyprus. COM (77) 264 final, 14 June 1977 [O] . 1977

机译：关于理事会条例（EEC）的提案为办公室制定供应黄油的一般规则联合国难民事务高级专员办事处的某些部分1977年粮食援助计划下的塞浦路斯人口数量建议a理事会条例（EEC）·向联合国办事处供应脱脂奶粉难民事务高级专员对中国某些人口的影响塞浦路斯作为紧急粮食援助，依据法规（EEC）No 1299/76 建议a理事会条例（EEC）关于共同体资助某些与粮食援助有关的费用根据1974/75计划分配给该办公室的谷物形式联合国难民事务专员的某些部分塞浦路斯的人口。 COm（77）264决赛，1977年6月14日

Current status of the sunscreen regulation in the United States: 2011 Food and Drug Administration's final rule on labeling and effectiveness testing.

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