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Methylene Bis-Benzotriazolyl Tetramethylbutylphenol is an organic compound that absorbs ultraviolet (UV) light.
In Europe, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol is an approved UV filter, which means the ingredient can be added to sunscreen products that are designed to protect the skin from the sun. In Europe, sunscreen products are considered cosmetic products. In the United States, sunscreen products are Over-the-Counter (OTC) drugs and only certain ingredients have been approved by the Food and Drug Administration (FDA) for use in these products.
In assessing sunscreen active ingredients, the FDA reviews both safety and efficacy. The safety and efficacy of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol has not yet been reviewed for sunscreen use by the FDA and it cannot be used in sunscreen drug products. For cosmetics in the United States, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol can be used as a UV light absorber.
In this case, the ingredient serves to protect the product from deterioration by absorbing, reflecting, or scattering UV light.
Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, or Bisoctrizole, is a broad spectrum UV absorber, absorbing UVB as well as UVA rays, and has a stabilizing effect on other UV absorbers. UV radiation is an important cause of premature aging of the skin and in the development of melanoma and other forms of skin cancer.
The European Commission's Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) conducted a safety evaluation of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol. Based on their review, they concluded that use of this ingredient in cosmetic products as a UV light absorber at a maximum concentration of 10% would not pose a health hazard.
The European SCCNFP concluded that there was no evidence of allergenicity, phototoxicity or irritation of 2,2" Methylene-bis-(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol), or Methylene Bis-Benzotriazolyl Tetramethylbutylphenol. This ingredient was not genotoxic and did not cause reproductive effects. The dermal absorption of this ingredient was very low.
Link to the European Commission's SCCNFP opinion concerning Methylene Bis-Benzotriazolyl Tetramethylbutylphenol http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out55_e...
Methylene Bis-Benzotriazolyl Tetramethylbutylphenol is listed in the Cosmetics Directive of the European Union and may be used as a UV filter in cosmetics and personal care products at a maximum concentration of 10% (see Annex VII).
Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm
Methylene Bis-Benzotriazolyl Tetramethylbutylphenol is a heterocyclic compound. In cosmetics and personal care products, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol functions as an UV light absorber. UV absorbers, like sunscreen agents, have the ability to convert UV radiation into less damaging infrared radiation (heat).
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: http://fdadrugcompliance.com/resources/otc/
Search the FDA 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/
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