Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 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.

Where this section sits in the code

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

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.

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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