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In cosmetics and personal care products, Homosalate is used in the formulation of sunscreen products, eyebrow pencils, lipsticks and skin care products.
Homosalate, 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. Homosalate can also be used to protect cosmetics and personal care products from deterioration by absorbing, UV rays
Homosalate has the ability to convert incident ultraviolet radiation into less damaging infrared radiation (heat).
The Food and Drug Administration (FDA) reviewed the safety of Homosalate and approved its use as an active ingredient in Over-the-Counter (OTC) sunscreen drug products at concentrations up to 15%. The Cosmetic Ingredient Review (CIR) Expert Panel has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.
Link to FDA Code of Federal Regulations for Homosalate
Homosalate 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
There are studies that suggest that some sunscreen ingredients, including Homosalate 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.
Link to SCCNFP opinion on the potential estrogenic effects of UV filters http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out145_...
More information about endocrine disruptors.
Health Canada permits the use of Homosalate in sunscreen products at a maximum concentration of 15%.
Homosalate is an ester formed from salicylic acid and 3,3,5-trimethylcyclohexanol. In cosmetics and personal care products, Homosalate functions as a sunscreen agent and as a UV light absorber.
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/cder/offices/otc/default.htm
Information about OTC Drug monographs: http://www.fda.gov/cder/otcmonographs/rulemaking_index.htm
Search the FDA Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
The European Commission's Scientific Committee on Consumer Products (SCCP) opinion on Homosalate. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_097.pdf
EU Cosmetic Ingredients Inventory http://ec.europa.eu/enterprise/cosmetics/inci/inci_2006.pdf
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