# Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates
> **Food and Drug Administration** · Final rule; delay of compliance dates; request for comments. · Published 2012-05-11 · Effective 2012-06-18 · 77 FR 27591
## Document
- **Document number:** 2012-11390
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 77 FR 27591
- **CFR reference:** 21 CFR 201
- **Publication date:** 2012-05-11
- **Effective date:** 2012-06-18
- **HHS docket:** Docket No. FDA-1978-N-0018
## Abstract

The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2012/05/11/2012-11390/labeling-and-effectiveness-testing-sunscreen-drug-products-for-over-the-counter-human-use-delay-of)
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