§ M020.1 Scope

Law · OTC Monograph M020.1 · posted 24 Sep 2021 · checked 30 Sep 2026 · Official source: accessdata.fda.gov

An over-the-counter (OTC) sunscreen drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this OTC monograph and each general condition established in 21 CFR 330.1.

1 Final Administrative Order (OTC000006), effective upon enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law 116-136, on March 27, 2020.

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