U.S. Food and Drug Administration (FDA)
The FDA lists ZnO as generally recognized as safe (GRAS) as a nutrient. It is approved as an indirect food additive as a colorant of some polymers in contact with food. ZnO is an approved colorant for use in color cosmetics products, including those applied to the lips and eye area, and as a colorant in drug products. FDA approves colors only after extensive review of all safety data. When used as a colorant in cosmetics or other FDA-regulated products, zinc oxide must comply with the identity, specifications, uses, restrictions and labeling requirements stated in the regulations [21 CFR 73].
Additionally, the FDA has approved the use of ZnO in over-the-counter (OTC) skin protectants and anorectal skin protectant drug products.
Sunscreens are regulated by the FDA as non-prescription, OTC drugs through a monograph system, which establishes various requirements for the product to be sold in the U.S. A monograph specifies the types of ingredients, dosage forms, testing methods, labeling requirements, and other related details for a product category, such as sunscreens. If a manufacturer follows the sunscreen monograph, its sunscreen products do not require separate FDA pre-approval before they can be sold in the U.S.
While the FDA proposed an Administrative Order on Sept. 27, 2021, that would amend conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE), the GRASE status for ZnO is not expected to change once the proposed Administrative Order is finalized.
Expert Panel for Cosmetic Ingredient Safety
The Expert Panel for Cosmetic Ingredient Safety (Expert Panel) has deferred evaluation of this ingredient because the safety has been assessed by the FDA. This deferral follows the Expert Panel’s procedures.
The Cosmetics Directive of the European Union approved ZnO as a colorant (see Annex IV ). When used in cosmetics products, it is labelled CI 77947. In its Sept. 18, 2012, opinion (revised Sept. 23, 2014), the EU’s Scientific Committee on Consumer Safety (SCCS) concluded ZnO is safe when used as a colorant in cosmetics for dermal application in its uncoated, non-nano particle form (see separate webpage on nanotechnology). However, in light of subsequent SCCS concerns of potential lung inflammation induced by ZnO particles after inhalation, the European Commission amended Annex IV of the Cosmetics Regulation in August 2017 to stipulate that ZnO as a colorant in its uncoated, non-nanoparticle form in cosmetics products should be restricted to applications that will not lead to exposure of the end-user’s lungs.
ZnO is also allowed as a UV filter in the EU at concentrations up to 25%. The SCCS has thoroughly reviewed the safety of nanoscale (1-100 nm) ZnO used in sunscreens and concluded it does not pose a risk of adverse effects. In 2016, the European Commission amended Annex VI of the EU Cosmetics Regulation to also include nano-sized ZnO as a permitted UV filter in ready-to-use cosmetics products. Both nano and non-nano forms are restricted to applications that will not lead to exposure of the end-user’s lungs.