§347.10. Skin protectant active ingredients.
21 C.F.R. § 347.10
The active ingredients of the product consist of any of the following, within the concentration specified for each ingredient:
Allantoin, 0.5 to 2 percent.
Aluminum hydroxide gel, 0.15 to 5 percent.
Calamine, 1 to 25 percent.
Cocoa butter, 50 to 100 percent.
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.
Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil in accordance with § 347.20(a)(4).
Dimethicone, 1 to 30 percent.
Glycerin, 20 to 45 percent.
Hard fat, 50 to 100 percent.
Kaolin, 4 to 20 percent.
Lanolin, 12.5 to 50 percent.
Mineral oil, 50 to 100 percent; 30 to 35 percent in combination with colloidal oatmeal in accordance with § 347.20(a)(4).
Petrolatum, 30 to 100 percent.
[Reserved]
Sodium bicarbonate.
[Reserved]
Topical starch, 10 to 98 percent.
White petrolatum, 30 to 100 percent.
Zinc acetate, 0.1 to 2 percent.
Zinc carbonate, 0.2 to 2 percent.
Zinc oxide, 1 to 25 percent.
Notes, amendments, and revision history
Source
Source: 68 FR 33377, June 4, 2003, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source
Source: 58 FR 54462, Oct. 21, 1993, unless otherwise noted.