Benzophenone-3

What Is It?

Benzophenone-1, -3, -4, -5, -9 and-11 are compounds made from 2-hydroxybenzophenone. These compounds are powders. In cosmetics and personal care products, Benzophenone-1 and Benzophenone-3 are used mostly in the formulation of nail polishes and enamels. These Benzophenone ingredients are also used in bath products, makeup products, hair products, sunscreens and skin care products.

Why Is It Used?

Benzophenone-1, Benzophenone-3, Benzophenone-4, Benzophenone-5, Benzophenone-9 and Benzophenone-11 protect cosmetics and personal care products from deterioration by absorbing, reflecting, or scattering UV rays. When used as sunscreen ingredients, Benzophenone-3 and Benzophenone-4 protect the skin from UV rays.

Scientific Facts

Benzophenone ingredients absorb and dissipate UV radiation, which serves to protect cosmetics and personal care products. As part of sunscreen products, which are OTC drugs in the United States, Benzophenone-3 (Oxybenzone) and Benzophenone-4 (Sulisobenzone) protect the skin from the harmful effects of the sun.

Exposing unprotected skin to UV light (primarily in the UV-B range) can result in sunburn and can promote premature aging of the skin and skin cancer.

Safety Information

The Food and Drug Administration (FDA) has approved the use of Benzophenone-3 and Benzophenone-4 as safe and effective, over-the-counter (OTC) sunscreen ingredients. When used as a sunscreen ingredient in the United States, Benzophenone-3 is called Oxybenzone, and may be used at concentrations up to 6%, and Benzophenone-4 is called Sulisobenzone, and may be used at concentrations up to 10%. The safety of Benzophenone-3 and related ingredients has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Benzophenone-1, -3, -4, -5, -9 and -11 were safe for use in cosmetics and personal care products. In 2002, the CIR Expert Panel considered available new data on these Benzophenone ingredients and reaffirmed the above conclusion.

CIR Safety Review:

When undiluted, some Benzophenones, were slightly irritating to the skin and eyes. At concentrations used in cosmetics and personal care products, Benzophenoens were not irritating. Benzophenone-3 was nonsensitizing and nonphototoxic. Benzophenones were nonmutagenic when tested both with and without metabolic activation.

FDA: Link to Code of Federal Regulations for Benzophenone-3 (Oxybenzone) and Benzophenone-4 (Sulisobenzone)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF… Benzophenone-3, listed as Oxybenzone, and Benzophenone-4 and -5, listed as Sulisobenzone and Sulisobenzone Sodium, respectively, are included in Annex VII, Part 1 (UV filter which cosmetic products may contain) of the Cosmetics Directive of the European Union. Oxybenzone may be used at concentrations up to 10%, and products containing 0.5% Oxybenzone when used in sunscreen products must be labeled “contains Oxybenzone.” Sulisobenzone and Sulisobenzone Sodium may be used at concentrations up to 5% as Sulisobenzone.

There are studies that suggest that some sunscreen ingredients, including Oxybenzone may have activity like the hormone, estrogen. Therefore, the European Commission’s Scientific Committee for Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) was asked to consider if UV filters as used in sunscreen products have estrogenic effects which have the potential to affect human health. The SCCNFP concluded that UV filters used in sunscreen products allowed in the European market have no estrogenic effects that could potentially affect human health.

More Scientific Information

The Benzophenones are a group of aromatic ketones, all of which contain the diphenylketone structural element. The remaining ring substituents, normally -OH, -OCH3, and -SO3H groupings, improve the solubility of these ketones and alter their ability to absorb ultraviolet light.

They are used as photostabilizers of cosmetic and personal care products and have a photoprotective effect on the skin when used in sunscreen products.

Resources

Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration