Zinc Oxide, a white powder, is the oxide of zinc. It has a
formula of ZnO. Zinc Oxide is used in a wide range of cosmetics and
personal care products including makeup, nail products, baby lotions,
bath soaps and foot powders. Zinc Oxide is also used in
Over-the-Counter (OTC) drug products such as skin protectants
including ano-rectal skin protectant
products, for example, diaper rash ointments, and sunscreen products.
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.