Ethylhexyl Dimethyl PABA

The Food and Drug Administration (FDA) reviewed the safety of Ethylhexyl Dimethyl PABA and approved its use as an active ingredient in Over-the-Counter (OTC) sunscreen drug products at concentrations up to 8%. When used in OTC sunscreen drug products, Ethylhexyl Dimethyl PABA is called Padimate O 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) 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 Padimate O (Ethylhexyl Dimethyl PABA)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Ethylhexyl Dimethyl PABA is listed as 4-dimethyl-amino-benzoate of ethyl-2-hexyl in the Cosmetics Directive of the European Union and may be used as a UV filterUV filters are ingredients that filter certain UV rays that are found in sunlight and, to a lesser degree, artificial light. UV filter is a general term that is used for sunscreen agents, ingredients used to protect the skin from UV rays, and ultraviolet light absorbers, ingredients use to protect products, packaging and hair from UV rays. in cosmetics and personal care products at a maximum concentration of 8% (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 Padimate O 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 Padimate O in sunscreen products at concentrations of 8% or less.