SPF Labeling and Testing Requirements for OTC Sunscreen Products

This ICR pertains to testing and labeling requirements for OTC sunscreen products marketed containing specified active ingredients and marketed without an approved new drug application or abbreviated new drug application. OTC sunscreen products are required to be tested according to the SPF test procedure in 21 CFR 201.327(i). OTC sunscreen product must be labeled with its SPF value on its principal display panel according to labeling requirements in 21 CFR 201.327(a)(1). The requirement to label OTC sunscreen products with an SPF value determined by the SPF test results in an information collection with a third-party disclosure burden for manufacturers of OTC sunscreen products. Compliance with the drug facts label requirement at 21 CFR 201.66 results in an additional third-party disclosure burden for these manufacturers.

The latest form for SPF Labeling and Testing Requirements for OTC Sunscreen Products expires 2022-03-31 and can be found here.

Conduct Sun Protection Factor Testing for New Sunscreen Formulations

Federal Enterprise Architecture: Health - Consumer Health and Safety