# Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph
> **Food and Drug Administration** · Final rule. · Published 1999-05-21 · Effective 2001-05-21 · 64 FR 27666
## Document
- **Document number:** 99-12853
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 64 FR 27666
- **CFR reference:** 21 CFR 310
- **Publication date:** 1999-05-21
- **Effective date:** 2001-05-21
- **HHS docket:** Docket No. 78N-0038
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and new data and information on sunscreen drug products that have come to the agency's attention. FDA is also issuing final rules regarding the labeling of certain cosmetic products to inform consumers that these products do not provide protection from the sun.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1999/05/21/99-12853/sunscreen-drug-products-for-over-the-counter-human-use-final-monograph)
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