21 CFR § 352.1 Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely]

§ 352.1 Scope.

Current through Sep 8, 2026 · Read all of Part 352

(a) An over-the-counter 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 part and each general condition established in § 330.1 of this chapter.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.

§ 352.3 Definitions. →