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# 2 Sunscreen Guidances Published
- URL: https://www.fdaweb.com/2-sunscreen-guidances-published/
- Published: 2016-11-22T12:00:00.000Z
- Updated: 2026-09-14T21:49:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137402

FDA has issued two guidances in partial fulfillment of requirements under the 2014 Sunscreen Innovation Act. 

The first guidance, *Nonprescription Sunscreen Drug Products—Safety and Effectiveness Data*, addresses the agency’s thinking about data needed to determine whether a nonprescription over-the-counter sunscreen ingredient or combination of ingredients evaluated under the Sunscreen Innovation Act is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM473464.pdf?ref=fdaweb.com) says its recommendations are designed to ensure that FDA’s GRASE determinations for OTC sunscreen active ingredients under the law are consistent, up to date, and appropriately reflect current scientific knowledge and patterns of nonprescription sunscreen use by consumers. It also addresses the agency’s thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future.

The second guidance, *Nonprescription Sunscreen Drug Products—Format and Content of Data submissions*, gives the agency’s [thinking](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM473772.pdf?ref=fdaweb.com) in information to be supplied to support a request or pending request for a determination of whether an OTC sunscreen active ingredient or combination of ingredients is GRASE and should be included in the OTC sunscreen drug monograph.