The 2003 final rule set the over-the-counter skin protectant monograph that is now codified at 21 CFR 347. It includes zinc oxide at 1 to 25 percent (§347.10(u)). It defers diaper rash claims, and a prickly-heat claim, to the separate diaper rash final rule. It sets no heavy-metal limit.
Key numbers
The rule was effective 4 June 2004, with a compliance date of 6 June 2005 for products with annual sales under $25,000. It cites the 1990 diaper rash proposal (55 FR 25204) several times: for cod liver oil (at 25213), lanolin (25218 to 25219), mineral oil (25220 to 25221) and topical starch. It states that the agency “will discuss a ‘prickly heat’ claim in the skin protectant diaper rash drug products final rule”. The final §347.10 matches the 2025 codified list for the ingredients relevant to diaper creams.
Methods (brief)
This is a Federal Register final rule responding to comments. The file’s first page also carries the end of an unrelated notice.
Evidence fitness
The rule supports the composition envelope for US skin protectants and the fact that diaper-rash use was left to a later rule. It does not provide any metal specification.
Limitations
Whether a diaper-rash final rule issued after 2003 is not established from this collection. The operative post-2020 OTC Monograph M016 was not obtained.
Related evidence
- Diaper Cream, ZnO-Based
- 21 CFR Part 347, Skin protectant drug products for over-the-counter human use (4-1-25 edition)
- Skin Protectant Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Diaper Rash Drug Products; Proposed Rule
Update history
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