Titanium Dioxide is a naturally occurring mineral derived from oxide of titanium.
The oxides are typically mined and then further processed and purified for use in consumer products.
Titanium Dioxide is used to impart a whiteness to color cosmetics and personal care products that are applied to the skin (including the eye area), nails, lips, and it helps to increase the opacity, and reduce the transparency of a product formula. Titanium Dioxide also absorbs, reflects, or scatters light (including ultraviolet radiation in light), which can help protect products from deterioration.
Titanium Dioxide is an important ingredient used in sunscreen products. Sunscreens are regulated by the Food and Drug Administration (FDA) as Over-The-Counter (OTC) drug products. As such, they must be demonstrated to be safe and effective in protecting the user from the harmful effects of ultraviolet radiation that is part of sunlight.
The FDA has assessed the safety of Titanium Dioxide as a color additive for use in foods, drugs and cosmetics and has issued regulations approving the ingredient for these purposes.
Link to FDA color additive regulation for food: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr...
Link to FDA color additive regulation for cosmetics: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr...
The FDA has also assessed the use of Titanium Dioxide as an active ingredient for use in OTC sunscreen drug products and has determined that it is safe for this use. As a result of this assessment, FDA has issued regulations that describe the conditions of use of Titanium Dioxide in sunscreen drug products.
Link to the FDA regulation allowing the use of Titanium Dioxide as a sunscreen active ingredient:
In Europe, Titanium Dioxide is listed as Colour Index No. 77891 in the Cosmetics Directive of the European Union as an allowed color additive (Annex IV, Part I) and may be used without restriction according to the purity requirements that have been established for the quality of the same material used in foods.
Europe also allows Titanium Dioxide to be used as an sunscreen active ingredient to protect against the adverse effects of ultraviolet radiation found in sunlight.
Link to the EU Cosmetics Directive (select English = EN and scroll down to Annex VII): http://ec.europa.eu/enterprise/cosmetics/html/consolidated_dir.htm
In February 2006, a working group of the International Agency for Research on Cancer (IARC) reported on its assessment of titanium dioxide. The working group stated that there is inadequate evidence in humans for the carcinogenicity of titanium dioxide, but sufficient evidence for its carcinogenicity in experimental animals, and classified the substance as possibly carcinogenic to humans. To date, the IARC working group's statements have not led the FDA to change the regulatory status in the U.S of titanium dioxide.
Some personal care products may contain nanoscale particles of titanium dioxide and zinc oxide that are used as active ingredients in sunscreen products and have been approved for use by the Food and Drug Administration (FDA) since 1999. These nanoscale particles have been developed by breaking down larger particles during the manufacturing process. Titanium Dioxide and Zinc Oxide have been extensively evaluated and the scientific data shows that they do not penetrate the skin.