Title 21, Food and DrugsRelease 119-102
§360fff–1 Submission of Requests
Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part I — Nonprescription Sunscreen and Other Active Ingredients › § 360fff–1
Summary
Anyone may ask the Secretary to decide if a nonprescription sunscreen ingredient or combination, for the labeled use (form, strength, and how it’s applied), is GRASE and should be added to 21 CFR part 352 (or any successor regulations). GRASE means generally recognized as safe and effective.
Full Legal Text
Title 21, §360fff–1
Food and Drugs, Source: USLM XML via OLRC
Any person may submit a request to the Secretary for a determination of whether a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dosage strength, and route of administration) is GRASE and should be included in part 352 of title 21, Code of Federal Regulations (or any successor regulations) concerning nonprescription sunscreen.
Reference
Citations & Metadata
Citation
21 U.S.C. § 360fff–1
Title 21, Food and Drugs
Last Updated
Aug 21, 2026
Release point: 119-102