ZINC OXIDE

ZINC OXIDE is an inorganic oxide of zinc, also identified by the name CI 77947 when used as a colorant under EU labelling. In pharmacopoeial terminology it is designated as zinci oxidum. The CosIng entry assigns it multiple functions: antimicrobial, bulking agent, colorant, oral care, skin protectant, light stabilizer, UV absorber and UV filter.

In EU law, the substance appears in Annex IV, reference 144, corresponding to the list of colorants authorized in cosmetic products. The cosmetic restrictions recorded for this entry cover references IV/144, VI/30 and VI/30a. The literal mandatory labelling warning is: "Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation." For use as a colorant subject to labelling requirements on the EU market, the INCI name that must be used is CI 77947. Declared color: White.

The associated cosmetic restrictions comprise entries IV/144, VI/30 and VI/30a. The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.

ZINC OXIDE is an inorganic oxide; its INN is zinc oxide and its European Pharmacopoeia name is zinci oxidum. The entry is assigned multiple technical functions: antimicrobial, bulking, colorant, oral care, skin protecting, light stabilizer, UV absorber and UV filter.

ZINC OXIDE appears in Annex VI, reference 30. The maximum authorized concentration is expressed as "25%", accompanied by the literal condition: "In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%". The mandatory labelling warning states: "Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation." The substance also appears in Annex IV, reference 144, and its nano form in Annex VI, reference 30a (ZINC OXIDE (NANO)), which indicates its parallel treatment under different annexes of the Regulation on cosmetic products.

The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.

ZINC OXIDE (NANO) is the nanoparticulate form of zinc oxide, an inorganic compound belonging to the class of metal oxides.

The ingredient is listed in Annex VI, reference 30a, of Regulation (EC) No 1223/2009. The maximum authorized concentration is 25%, with the literal clarification: "In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%". The conditions of use include the mandatory labelling warnings: "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."

The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.