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GUIDANCE DOCUMENT

Nonprescription Sunscreen Drug Products – Format and Content of Data Submissions November 2016

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance addresses the current thinking of the Food and Drug Administration (FDA or Agency) on the format and content of information provided to support a request submitted under section 586A (586A request) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360fff-1), as amended by the Sunscreen Innovation Act (SIA) (21 U.S.C. Ch. 9 Sub. 5 Part I, enacted November 26, 2014), or in support of a pending request, as defined under section 586(6) of the FD&C Act (21 U.S.C. 360fff(6)).
 


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.