---
kind: "section"
citation: "21 C.F.R. § 347.10"
title: "21"
number: "347.10"
heading: "Skin protectant active ingredients."
url: "https://uscodex.org/cfr/21/347.10"
---

# §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)](/cfr/21/347.20.md?p=a-1) or [(a)(2)](/cfr/21/347.20.md?p=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)](/cfr/21/347.20.md?p=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)](/cfr/21/347.20.md?p=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.**

## Notes

### 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.