# Sunscreen Drug Products for Over-the-Counter Human Use; Marketing Status of Products Containing Avobenzone; Enforcement Policy
> **Food and Drug Administration** · Announcement of Enforcement Policy. · Published 1997-04-30 · Effective 1997-04-30 · 62 FR 23350
## Document
- **Document number:** 97-11116
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 23350
- **CFR reference:** 21 CFR 352
- **Publication date:** 1997-04-30
- **Effective date:** 1997-04-30
- **HHS docket:** Docket No. 78N-0038
## Abstract

The Food and Drug Administration (FDA) is announcing an enforcement policy allowing over-the-counter (OTC) marketing of sunscreen drug products containing avobenzone (Parsol<Register> 1789) at concentrations of up to 3 percent alone and 2 to 3 percent avobenzone in combination with the OTC sunscreen ingredients cinoxate, diethanolamine methoxycinnamate, dioxybenzone, homosalate, octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone, sulisobenzone, and/or trolamine salicylate. OTC marketing of such drug products is being permitted pending establishment under the OTC drug review of a final monograph covering sunscreen drug products. FDA anticipates that sunscreen drug products containing up to 3 percent avobenzone alone and 2 to 3 percent avobenzone in combination with the proposed Category I cinnamate, benzophenone, salicylate, and/or diphenylacrylate sunscreen ingredients will be determined to be generally recognized as safe and effective and not misbranded.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/04/30/97-11116/sunscreen-drug-products-for-over-the-counter-human-use-marketing-status-of-products-containing)
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