Issue Date: November 22, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Over-the-Counter Drugs
Status: Final
Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data
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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