FDA proposed that zinc oxide and titanium dioxide are the only two of sixteen listed sunscreen active ingredients that are generally recognised as safe and effective (Category I), each at up to 25 %. FDA based the zinc oxide proposal largely on evidence that zinc oxide, including nanoscale particles, does not penetrate human skin to any great extent. It did not propose separate conditions for nanomaterial forms. The proposal contains no heavy-metal impurity limits for sunscreen actives or finished sunscreens.
Key numbers
- Zinc oxide and titanium dioxide proposed Category I at up to 25 percent (84 FR 6216, PDF p. 13).
- Nanoscale described as approximately 1 to 100 nm; FDA “is not proposing to categorically classify” nanomaterial sunscreens as GRASE or not GRASE on that basis (PDF p. 12-13).
- Existing labelling at 21 CFR 201.327(e)(1)(iv): “children under 6 months of age: Ask a doctor” (PDF p. 44).
Methods (brief)
Rulemaking review of literature, monograph docket submissions and adverse event reports. The text refers to USP monographs for ingredient quality; no metal specification is set in the proposal.
Evidence fitness
Supports the US regulatory status of mineral sunscreen actives as proposed in 2019. It cannot supply a finished-product heavy-metal limit, because none is proposed. The 2021 deemed final order and proposed order under the CARES Act were not obtained.
Limitations
Proposed, not final. Adult-focused safety data; infants under six months are addressed only through labelling.
Related evidence
- Baby Sunscreen, Mineral (ZnO + TiO2)
- 21 CFR Part 73 color additives exempt from certification, 4-1-2023 edition
- Primary Sunscreen Monograph
Update history
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