CAS 13463-67-7[1]/ 1317-70-0[2]/ 1317-80-2[3] ·
No specific rule on file.
Approved UV filter Annex VI/27a
Maximum: 25% - In case of combined use of Titanium Dioxide and Titanium Dioxide (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 ≥ 99 %, — rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, — median particle size based on number size distribution ≥ 30 nm, — aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3, — coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone; or coated with one of the following combinations: —Silica at a maximum concentration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %, —Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products), —Alumina at a maximum concentration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %, — photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference, — nanoparticles are photostable in the final formulation. Wording of conditions of use and warnings: For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips.
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.
TITANIUM DIOXIDE (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.