CAS 1314-13-2 ·
No specific rule on file.
Approved UV filter Annex VI/30a
Maximum: 25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%
Required label warning: Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total, — median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, — water solubility < 50 mg/L —uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross- polymer, or octyl triethoxy silane.
Source: EU CosIng — Annex VI · checked Oct 16, 2026
Not an FDA-listed sunscreen active M020 (not listed)
Conditions: Permitted as a UV filter elsewhere, but not on the FDA list of sunscreen active ingredients (§M020.10). It cannot be the active ingredient of a sunscreen marketed in the U.S. under the monograph.
Source: FDA OTC Monograph M020 (sunscreens) · checked Oct 16, 2026
This is a UV filter. In the U.S., sunscreens are regulated as over-the-counter drugs, so a filter must be on the FDA's list of permitted sunscreen actives to be used in a sunscreen sold there. Compare all filters on Sunscreen filters: Korea vs EU vs U.S.
ZINC OXIDE (NANO)
Information only, not medical advice. Rules change — always check the linked official source. If you are pregnant, have a skin condition or allergies, ask a dermatologist or pharmacist.