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.
Structure US Code
CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V— DRUGS AND DEVICES
Part I— Nonprescription Sunscreen and Other Active Ingredients
§ 360fff–1. Submission of requests
§ 360fff–2. Eligibility determinations; data submission; filing
§ 360fff–3. GRASE determination
§ 360fff–4. Guidance; other provisions