{"data":{"id":"us/21-cfr-347.10","jurisdiction":"us","citation":"21 CFR 347.10","heading":"Skin protectant active ingredients.","body":"The active ingredients of the product consist of any of the following, within the concentration specified for each ingredient:\n(a) Allantoin, 0.5 to 2 percent.\n(b) Aluminum hydroxide gel, 0.15 to 5 percent.\n(c) Calamine, 1 to 25 percent.\n(d) Cocoa butter, 50 to 100 percent.\n(e) Cod liver oil, 5 to 13.56 percent, in accordance with § 347.20(a)(1) or (a)(2), provided the product is labeled so that the quantity used in a 24-hour period does not exceed 10,000 U.S.P. Units vitamin A and 400 U.S.P. Units cholecalciferol.\n(f) Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil in accordance with § 347.20(a)(4).\n(g) Dimethicone, 1 to 30 percent.\n(h) Glycerin, 20 to 45 percent.\n(i) Hard fat, 50 to 100 percent.\n(j) Kaolin, 4 to 20 percent.\n(k) Lanolin, 12.5 to 50 percent.\n(l) Mineral oil, 50 to 100 percent; 30 to 35 percent in combination with colloidal oatmeal in accordance with § 347.20(a)(4).\n(m) Petrolatum, 30 to 100 percent.\n(n) [Reserved]\n(o) Sodium bicarbonate.\n(p) [Reserved]\n(q) Topical starch, 10 to 98 percent.\n(r) White petrolatum, 30 to 100 percent.\n(s) Zinc acetate, 0.1 to 2 percent.\n(t) Zinc carbonate, 0.2 to 2 percent.\n(u) Zinc oxide, 1 to 25 percent.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 347—SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE","Subpart B—Active Ingredients"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"8239d8f289f644eb96b02a667ac71c4711a6c7022048675bbb157028a5fdaada","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-347.3","next":"us/21-cfr-347.12"},"notice":"GroundRules: Original legal text. Not legal advice."}