Zinc oxide (C1 77947). The Food and Drug Administration (FDA) lists Zinc Oxide as a color additive exempt from certification. Zinc Oxide is safe for use in coloring products, including cosmetics and personal care products applied to the lips, and the area of the eye, provided it meets certain specifications. Zinc Oxide is also an approved colorant for drugs, and it is approved as an indirect food additive for use as a colorant of some polymers in contact with food. The FDA has also approved the use of Zinc Oxide for use in OTC skin protectants and ano-rectal skin protectant drug products at concentrations up to 25%, and in sunscreen drug products at concentrations up to 25%. FDA also includes Zinc Oxide on its list of substances considered Generally Recognized as Safe (GRAS) as a nutrient. The Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures. The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations: 1. ZnO nanoparticles of 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. 2. ZnO nanoparticles with a median diameter (D50: 50% of the number below this diameter) of the particle number size distribution above 30 nm, and the D1 (1% below this size) above 20nm. 3. ZnO nanoparticles that are either uncoated or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane. Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion.

Source: Dweck, Anthony. Handbook of Cosmetic Ingredients: - their use, safety and toxicology (Dweck Books 5)

‍