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GUIDANCE DOCUMENT

Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data November 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-4021
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance addresses the current thinking of the Food and Drug Administration’s (FDA or Agency) about the safety and effectiveness data needed to determine whether a nonprescription (also referred to as an over-the-counter (OTC)) sunscreen active ingredient, or combination of active ingredients, evaluated under the Sunscreen Innovation Act (SIA) (21 U.S.C. Ch. 9, Sub. 5 Part I, enacted November 26, 2014) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions.
 

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