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Ethylhexyl Dimethyl PABA is a yellowish, oily liquid. In cosmetics and personal care products, Ethylhexyl Dimethyl PABA is used in the formulation of sunscreen products, shampoos, conditioners, hair sprays, makeup, and bath and skin products.
When it is used in sunscreen drug products, Ethylhexyl Dimethyl PABA is called Padimate O.
Padimate O, 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.
Ethylhexyl Dimethyl PABA can also be used to protect cosmetics and personal care products from deterioration by absorbing, UV rays
Ethylhexyl Dimethyl PABA, or Octyl Dimethyl para-Aminobenzoic Acid (PABA), absorbs ultraviolet radiation and converts it into less damaging infrared radiation (heat).
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 Review (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)
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 filter 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.
Ethylhexyl Dimethyl PABA is the ester of 2-ethylhexyl alcohol and p-aminobenzoic acid. In cosmetics and personal care products, Ethylhexyl Dimethyl PABA functions as a sunscreen agent and an 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/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
The European Commission Scientific Committee for Cosmetic Products and Non-Food Products (SCCNFP) Opinion on Ethylhexyl Dimethyl PABA http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out54_e...
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