# Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Availability
> **Food and Drug Administration** · Notice of availability. · Published 2011-06-17 · 76 FR 35665
## Document
- **Document number:** 2011-14767
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 35665
- **CFR reference:** 21 CFR 201
- **Publication date:** 2011-06-17
- **HHS docket:** Docket No. FDA-2010-D-0509
## Abstract

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application." The draft guidance is intended to inform manufacturers of over-the-counter (OTC) sunscreen products about our enforcement policy for certain OTC sunscreen products marketed without an approved new drug application. The draft guidance describes our intended approach to enforcement for certain OTC sunscreen products prior to an effective final monograph.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/06/17/2011-14767/draft-guidance-for-industry-on-enforcement-policy-for-over-the-counter-sunscreen-drug-products)
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