Benzophenone-2
What Is It?
Benzophenone-2, -6 and -8 are compounds made from 2-hydroxybenzophenone. In cosmetics and personal care products, Benzophenone-2, -6 and -8 are used in the formulation of aftershave lotion, bath products, bubble baths, colognes, perfumes, eye makeup removers, and other skin and hair care products.
Why Is It Used?
Benzophenone-2, -6 and -8 protect cosmetics and personal care products from deterioration by absorbing, reflecting, or scattering UV rays. Benzophenone-8 when applied to the skin, absorbs UV rays. In addition to causing sunburn, UV radiation is a significant cause of premature aging of the skin and contributes to the development of melanoma and other forms of skin cancer. When used in OTC sunscreen drug products, Benzophenone-8 must be called Dioxybenzone.
Scientific Facts
Benzophenones 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-8 (Dioxybenzone) protects the skin from the harmful effects of the sun. Exposing unprotected skin to UV light 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-8 as a safe and effective, Over-the-Counter (OTC) drug sunscreen ingredient at concentrations up to 3%. When used as a sunscreen ingredient in the United States, Benzophenone-8 must be called Dioxybenzone. The safety of Benzophenone-2, -6 and -8 has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expet Panel evaluated the scientific data and concluded that these ingredients were safe for use in cosmetics and personal care products. In 2002, the CIR Expert Panel considered available new data on Benzophenones and reaffirmed the above conclusion.
CIR Safety Review: When ingested and absorbed, Benzophenones were primarily bound to water soluble compunds and excreted in the urine. Benzophenones were practically nontoxic when chronically administered via the oral route. Benzophenones were nonirritating or mildly irritating to skin at concentrations up to 100% and practically nonirritating to the eyes. Benzophenones-2, -6 and -8 were not mutagenic or genotoxic. Skin irritation and sensitization studie in humans indicated that Benzophenones were mildly irritating and sensitizing at concentrations greater than those used in cosmetics and personal care products.
Link to FDA Code of Federal Regulations for Dioxybenzone (Benzophenone-8)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Benzophenone-2, -6 and -8 are not listed among the permitted UV filters in the Csometics Directive of the European Union (see Annex VII). Therefore, these ingredients cannot be used in products to protect the skin from the harmful effects of the sun. When used to protect the product from UV radiation, Benzophenone-2, -6 and -8 may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
More Scientific Information
Benzophenone-2, -6 and -8 function as ultraviolet light absorbers in cosmetics and personal care products. Benzophenone-8 also functions as a suncreen agent. When used as a sunscreen agentIngredients that are applied to the skin to absorb, to reflect, or to scatter UV rays. In the United States, sunscreen agents are regulated as Over-The-Counter (OTC) drug ingredients., Benzophenone-8 must be called Dioxybenzone.
Resources
Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration
OTC Drug Home Page: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSa…
Information about OTC Drug monographs: https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/