GUIDANCE DOCUMENT
Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application May 2018
- Docket Number:
- FDA-2010-D-0509
- Issued by:
-
Guidance Issuing OfficeCenter 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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Dockets Management
Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0509.