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Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data November 2016

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.