Ethylhexyl Methoxycinnamate

What Is It?

Ethylhexyl Methoxycinnamate is a clear liquid that is insoluble in water. Ethylhexyl Methoxycinnamate is used in the formulation of a wide variety of product types including sunscreens and makeup products that contain ingredients to protect the skin from the sun. In the United States, these products are regulated as Over-the-Counter (OTC) drugs.

Why Is It Used?

Ethylhexyl Methoxycinnamate or Octinoxate is used in products that are applied to the skin to absorb, reflect or scatter UV rays. This serves to protect the skin from sunburn as well as other damaging effects of the sun. Ethylhexyl Methoxycinnamate also protects cosmetics and personal care products from deterioration caused by UV rays. When used to protect the product, this ingredient is called Ethylhexyl Methoxycinnamate.

Scientific Facts

UV light has a wavelength shorter than visible light. Prolonged exposure to UV light may result in health effects in the skin, eye and immune system. UV light damages collagen and contributes to aging of skin. Ethylhexyl Methoxycinnamate (Octinoxate) can help protect against sunburn and other skin damage caused by UV light by absorbing UV radiation.

Safety Information

The Food and Drug Administration (FDA) conducted an OTC drug review of Ethylhexyl Methoxycinnamate (also called Octyl Methoxycinnamate) and approved the use of this ingredient as an active ingredient in sunscreen products up to a concentration of 7.5%. When used as an active ingredient in an OTC sunscreen product, this ingredient will be listed on the label as Octinoxate. The Cosmetic Ingredient Review (CIR) 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.

In the United States, when used as an OTC sunscreen ingredient, Ethylhexyl Methoxycinnamate (Octinoxate) must conform to the specifications provided in the U.S. Pharmacopeia.

FDA:

Link to the Code of Federal Regulations for Ethylhexyl Methoxycinnamate http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Ethylhexyl Methoxycinnamate is listed as Octyl Methoxycinnamate in Annex VII, Part I (UV filter which cosmetics products may contain) of the Cosmetics Directive of the European Union and may be used at a maximum concentration of 10%, including sunscreen products.

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 Ethylhexyl Methoxycinnamate 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_…

In Canada, Ethylhexyl Methoxycinnamate is permitted in sunscreen products at concentrations up to 8.5%.

More Scientific Information

Ethylhexyl Methoxycinnamate is the ester of 2-ethylhexyl alcohol and methoxycinnamic acid. Ethylhexyl Methoxycinnamate (Octinoxate) is used in cosmetics and personal care products as a sunscreen agent to protect the skin, and as an ultraviolet light absorber to protect products.

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/