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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-4033
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)).
 

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