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GUIDANCE DOCUMENT

Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application May 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0509
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance describes FDA’s enforcement approach with respect to over-the-counter (OTC) sunscreen products marketed without approved applications during the period before a final sunscreen monograph becomes effective. It is intended for manufacturers who market OTC sunscreen drug products without an approved application.

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All written comments should be identified with this document's docket number: FDA-2010-D-0509.