Issue Date: November 23, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Over-the-Counter Drugs
Status: Final
Nonprescription Sunscreen Drug Products – Format and Content of Data Submissions
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)).
Download the Guidance Document
