StacksVerified U.S. regulatory reference

21 CFR §347.10

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The active ingredients of the product consist of any of the following, within the concentration specified for each ingredient:
  1. (a)Allantoin, 0.5 to 2 percent.
  2. (b)Aluminum hydroxide gel, 0.15 to 5 percent.
  3. (c)Calamine, 1 to 25 percent.
  4. (d)Cocoa butter, 50 to 100 percent.
  5. (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.
  6. (f)Colloidal oatmeal, 0.007 percent minimum; 0.003 percent minimum in combination with mineral oil in accordance with § 347.20(a)(4).
  7. (g)Dimethicone, 1 to 30 percent.
  8. (h)Glycerin, 20 to 45 percent.
  9. (i)Hard fat, 50 to 100 percent.
  10. (j)Kaolin, 4 to 20 percent.
  11. (k)Lanolin, 12.5 to 50 percent.
  12. (l)Mineral oil, 50 to 100 percent; 30 to 35 percent in combination with colloidal oatmeal in accordance with § 347.20(a)(4).
  13. (m)Petrolatum, 30 to 100 percent.
  14. (n)[Reserved]
  15. (o)Sodium bicarbonate.
  16. (p)[Reserved]
  17. (q)Topical starch, 10 to 98 percent.
  18. (r)White petrolatum, 30 to 100 percent.
  19. (s)Zinc acetate, 0.1 to 2 percent.
  20. (t)Zinc carbonate, 0.2 to 2 percent.
  21. (u)Zinc oxide, 1 to 25 percent.