§ 347.10 Skin protectant active ingredients.

The active ingredients of the product consist of any of the following, within the concentration specified for each ingredient: (a) Allantoin, 0.5 to 2 percent. (b) Aluminum hydroxide gel, 0.15 to 5 percent. (c) Calamine, 1 to 25 percent. (d) Cocoa butter, 50 to 100 percent. (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. (f) Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil in accordance with § 347.20(a)(4). (g) Dimethicone, 1 to 30 percent. (h) Glycerin, 20 to 45 percent. (i) Hard fat, 50 to 100 percent. (j) Kaolin, 4 to 20 percent. (k) Lanolin, 12.5 to 50 percent. (l) Mineral oil, 50 to 100 percent; 30 to 35 percent in combination with colloidal oatmeal in accordance with § 347.20(a)(4). (m) Petrolatum, 30 to 100 percent. (n) [Reserved] (o) Sodium bicarbonate. (p) [Reserved] (q) Topical starch, 10 to 98 percent. (r) White petrolatum, 30 to 100 percent. (s) Zinc acetate, 0.1 to 2 percent. (t) Zinc carbonate, 0.2 to 2 percent. (u) Zinc oxide, 1 to 25 percent.