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Titanium dioxide is a naturally occurring mineral that is mined from the earth then further processed and purified for use in consumer products. Also known as titanium (IV) oxide or titania, it is the naturally occurring compound comprised of the metal titanium and oxygen. Titanium dioxide is safely used in many products from paint and food to drugs and cosmetics. It also plays a critical role in some sunscreen products as a way to protect skin from the sun’s harmful ultraviolet radiation.
Titanium dioxide is used as a colorant to make cosmetics and personal care products that are applied to the skin (including the eye area), nails, and lips white in color. It helps to increase the opaqueness, and reduce the transparency of product formulas. Titanium dioxide also absorbs, reflects, or scatters light (including ultraviolet radiation from the sun), which can cause products to deteriorate.
Titanium dioxide is an important active ingredient used in some sunscreen products. Sunscreens are regulated by the U.S. Food and Drug Administration (FDA) as over-the-counter (OTC) drugs. As such, they must be shown to be safe and effective and must comply with all other requirements listed in the FDA's OTC sunscreen monograph. Individual sunscreen active ingredients are reviewed by FDA and only those that are on FDA's monograph approved list may be used in sunscreen products marketed in the U.S.
Titanium dioxide is generally a white powder that gives products a white color. However, when it is made into a very fine powder, it no longer gives the product a white color. It is this fine material, sometimes called microfine or nanoscale titanium dioxide that is used in many OTC sunscreen products. Use of this ultrafine material enables the sunscreens to be applied as a clear film that consumers prefer over the antiquated, white opaque lotions. The availability of microfine titanium dioxide in sunscreen products helps increase consumer acceptance and usage. Practicing sun safety, including proper sunscreen use, is important in helping to reduce the incidence of skin cancer.
As a pigment, titanium dioxide is an FDA-approved food additive that is used to enhance the white color of certain foods, such as dairy products and candy, and to add brightness to toothpaste and some medications. It is also used as a flavor enhancer in a variety of non-white foods, including dried vegetables, nuts, seeds, soups, and mustard, as well as beer and wine.
Titanium Dioxide is used as an opacifying agent and a colorant. In OTC drug products, it is used as a sunscreen agent.
FDA lists titanium dioxide as a color additive used in coloring products, including cosmetics and personal care products applied to the lips, and the eye area, provided it meets certain specifications. Titanium dioxide is also an approved colorant for food, drugs and medical devices. FDA includes titanium dioxide on its list of indirect food additives. For example, it may be used as a colorant in food contact packaging materials. The FDA has also approved the use of titanium dioxide for use in OTC sunscreen drug products at concentrations up to 25%.
Because titanium dioxide is derived from minerals that are mined from the earth, it may contain small, trace amounts of heavy metals such as lead or cadmium. The levels of heavy metals in the titanium dioxide that is used in cosmetic and personal care products are tightly regulated by the FDA. Any tiny amount that may eventually be in cosmetic or personal care products does not pose a risk to human health.
European Union (EU)
Titanium dioxide is allowed for use as a cosmetic colorant in the European Union without restriction when purity requirements are fulfilled. When used as a colorant in cosmetic products in the European Union, this ingredient must be called CI 77891. In Europe, titanium dioxide is also an approved sunscreen ingredient and may be used at concentrations up to 25%.
Ultrafine/nanoscale particles of titanium dioxide have been approved for use in sunscreen products by FDA since 1999. Extensive scientific data demonstrates that nanoscale titanium dioxide does not penetrate the skin. The EU's Scientific Committee on Consumer Safety (SCCS) also issued an opinion in 2013 on the safety of nanoscale titanium dioxide particles used as sunscreens. In that opinion, the SCCS acknowledged that nanoscale particles of titanium dioxide do not penetrate the skin and concluded that their use at concentrations up to 25% as UV filters in sunscreens does not pose any risk of adverse effects in humans after application on healthy, intact or sunburnt skin. This conclusion, however, did not apply to applications that might lead to inhalation exposure to titanium dioxide nanoparticles (such as powders or sprayable products).
A 1979 U.S. National Toxicology Program study, in which titanium dioxide was fed at very high concentrations in the diet of mice and rats concluded that it did not cause cancer in either species.
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 (i.e., cancer causing potential) of titanium dioxide, but sufficient evidence for its carcinogenicity when inhaled at very high concentrations by experimental animals. Based upon these animal data, IARC classified titanium dioxide as possibly carcinogenic to humans. To date, this IARC classification has not led the FDA to change the regulatory status of titanium dioxide in the U.S.
FDA Regulations: Links to the FDA Code of Federal Regulations for Titanium Dioxide in the following applications: Colors
European regulatory information
EU Cosmetics Inventory
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