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 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.All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations. In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.
You can find out more about FDA regulation of colors at:
http://www.cfsan.fda.gov/~dms/cos-col.html
The FDA has conducted extensive reviews of the safety of Zinc Oxide for use as a color additive in drugs and cosmetics and as a sunscreen and skin protectant active ingredient. The results of these reviews are public processes. For example, you may view the public announcement that FDA published approving sunscreen active ingredients, including Zinc Oxide, at the following link:
http://www.fda.gov/cder/otcmonographs/Sunscreen/sunscreen_FR...
FDA Regulations:
Links to the FDA Code of Federal Regulations for Zinc Oxide in the following applications:
Colors
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
OTC Drug Products
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Food Additives
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
The use of Zinc Oxide as a color as CI 77947 (see Annex IV Part 1) is not restricted by the Cosmetics Directive of the European Union. When used as a color in cosmetic products in the European Union, this ingredient must be called CI 77947. In the European Union, Zinc is not allowed to be used as a UV filter.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
You can learn more about the regulation and labeling of colors at: http://www.personalcarecouncil.org/Content/NavigationMenu/Co...