The codified US monograph lists the active ingredients permitted in over-the-counter skin protectants and their concentration ranges. Zinc oxide is permitted at 1 to 25 percent. The part sets no limit for lead, cadmium, arsenic, mercury or any other elemental impurity in the finished product. The word “diaper” does not appear in the codified text. Diaper-rash claims were left to a separate rulemaking.
Key numbers
Section 347.10 (active ingredients) lists, among others: 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 with vitamin A and cholecalciferol caps; dimethicone 1 to 30 percent; glycerin 20 to 45 percent; kaolin 4 to 20 percent; lanolin 12.5 to 50 percent; mineral oil 50 to 100 percent; petrolatum and white petrolatum 30 to 100 percent; topical starch 10 to 98 percent; zinc acetate 0.1 to 2 percent; zinc carbonate 0.2 to 2 percent; and zinc oxide 1 to 25 percent (§347.10(u)). Section 347.12 lists astringents, including aluminum acetate at 0.13 to 0.5 percent.
Methods (brief)
This is the codified text as revised to April 1, 2025, printed from govinfo. Subpart B carries the source note 68 FR 33377, June 4, 2003.
Evidence fitness
The part supports the legal composition envelope for US skin-protectant drug products. It shows that a finished zinc oxide diaper product regulated as an OTC drug has no codified metal ceiling under this part. It does not show the current operative monograph. Since the 2020 CARES Act, that is OTC Monograph M016, which was not obtained. Products labelled 40% zinc oxide exceed the codified 25 percent. The 1990 diaper-rash proposal would have allowed 25 to 40 percent in an ointment dosage form.
Limitations
The text is the Code of Federal Regulations, not M016. Specifications for the zinc oxide ingredient itself come from the pharmacopoeia (USP), which was not obtained, or, where zinc oxide is used as a colour, from 21 CFR 73.1991.
Related evidence
- Diaper Cream, ZnO-Based
- Diaper Cream, Non-ZnO
- Skin Protectant Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Diaper Rash Drug Products; Proposed Rule
- Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph
- 21 CFR Part 73 color additives exempt from certification, 4-1-2023 edition
Update history
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