What Is It?
Titanium dioxide (TiO2) is a naturally occurring mineral compound that is mined from the earth and processed and purified for use in consumer products. Also known as titanium (IV) oxide or titania, it is comprised of the metal titanium and oxygen. TiO2 is used in many consumer products, from paint and food to drugs and cosmetics. It also plays a critical role in sunscreen products to protect skin from the sun’s harmful ultraviolet (UV) radiation.
Why is it used in cosmetics and personal care products?
TiO2 is a white powder, approved by the U.S. Food and Drug Administration (FDA) as a colorant in cosmetics and personal care products applied to the skin, nails and lips. It helps to increase the opaqueness and reduce the transparency of product formulas. TiO2 also absorbs, reflects or scatters light (including UV radiation from the sun), and protects sunscreens products from the effects of light, which can cause products to deteriorate.
TiO2 is also used as the active ingredient in sunscreen products to protect the skin from the harmful effects of the sun’s UV rays. Exposing unprotected skin to UV light can result in sunburn (primarily from UVB rays) and promote premature aging of the skin, as well as skin cancer (primarily from UVA rays).
TiO2 is also approved as an active sunscreen ingredient in Canada, Australia, the European Union and Japan.
The FDA lists TiO2 as an allowed color additive used in coloring products, including cosmetics and personal care products, provided it meets certain specifications. It is also an approved colorant for food, drugs and medical devices. In addition, the FDA includes it on a list of indirect food additives. For example, it may be used as a colorant in food contact packaging materials.
Use in Sunscreens
Sunscreens are regulated by the FDA as non-prescription, over-the-counter (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 TiO2 is not expected to change once the proposed Administrative Order is finalized.
Because TiO2 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 TiO2 that is used in cosmetic and personal care products are tightly regulated by the FDA. Any tiny amount that may eventually be in cosmetics or personal care products does not pose a risk to human health.
The Expert Panel for Cosmetic Ingredient Safety (formerly the Cosmetic Ingredient Review Expert Panel) has deferred evaluation of titanium dioxide because its safety has been assessed by the FDA. This deferral of review is according to the provisions of the CIR Procedures.
European Union (EU)
TiO2 is allowed as a cosmetics colorant without restrictions when purity requirements are fulfilled (Annex IV, entry 143). When used as a colorant in cosmetics products in the European Union, this ingredient is labelled as CI 77891. TiO2 is also approved as a sunscreen active ingredient (Annex VI, entries 27 and 27a).
Based on an opinion of the Scientific Committee on Consumer Safety (SCCS), in May 2021, Annex III, entry 321 of the EU cosmetics regulation was amended to restrict the use of powdered TiO2 in powder face products and in hair aerosol spray products. For all other product types, this form of TiO2 should not be used in applications that may lead to inhalation. A reference to these restrictions of titanium dioxide under Annex III was added in the relevant entries of TiO2’s Annex IV colorant and Annex VI sunscreen ingredient approved uses.
American Academy of Dermatology – “Is Sunscreen Safe?”
Skin Cancer Foundation – “Skin Cancer Issues and Research”
Centers for Disease Control & Prevention (CDC) – “Sun Safety”