C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] › Subpart A—General Provisions

21 C.F.R. § 352.1

Scope

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(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.

Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2022–2022 · leading case: Truss v. Bayer HealthCare Pharm., Inc. (S.D.N.Y. 2022).
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Truss v. Bayer HealthCare Pharm., Inc. (S.D.N.Y. 2022). “§ 301 et seq; 21 C.F.R. § 352.1 . The FDA promulgates a “monograph,” which is “a detailed regulation .”
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