21 U.S.C. § 360fff–1 — Submission of requests

Any person^* may ask the FDA to decide whether a nonprescription^* sunscreen active ingredient^*, or a combination of such ingredients, is GRASE^* — generally recognized as safe and effective. The request must describe the specific conditions for using the ingredient, including its dosage form, dosage strength, and how it's applied to the skin, exactly as they would appear on the product's label^*. The goal is to get the ingredient added to part 352 of title 21 of the Code of Federal Regulations (or whatever regulation replaces it), which lists approved nonprescription sunscreen^* ingredients.