TEA-Phenylbenzimidazole Sulfonate

What Is It?

Phenylbenzimidazole Sulfonic Acid, also called Ensulizole, is a white to pale beige powder. Potassium Phenylbenzimidazole Sulfonate, Sodium Phenylbenzimidazole Sulfonate and TEA-Phenylbenzimidazole Sulfonate are salts of Phenylbenzimidazole Sulfonate. In the United States, Phenylbenzimidazole Sulfonic Acid is used in sun protection products. When it is used in these products it is called Ensulizole. In addition to the acid, the European Union also permits the Potassium, Sodium and Triethanolamine (TEA) salts of Phenylbenzimidazole Sulfonic Acid to be used in sun protection products.

Why Is It Used?

When Phenylbenzimidazole Sulfonic Acid (Ensulizole) or it salts are applied to the skin these ingredients absorb 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. Phenylbenzimidazole Sulfonic Acid and its salts may also be used to protect cosmetics and personal care products from deterioration by absorbing, UV rays.

Scientific Facts

Phenylbenzimidazole Sulfonic Acid and its salts have the ability to convert incident ultraviolet radiation into less damaging infrared radiation (heat).

Safety Information

The Food and Drug Administration (FDA) reviewed the safety of Phenylbenzimidazole Sulfonic Acid and approved its use as an active ingredient in Over-the-Counter (OTC) sunscreen drug products at concentrations up to 4%. When used in OTC sunscreen drug products this ingredient is called Ensulizole. The European Commission’s Scientific Committee on Consumer Products (SCCP) reviewed the safety of Phenylbenzimidazole Sulfonic Acid and its Potassium, Sodium and TEA salts and concluded that the use of these ingredients in cosmetic products at a maximum concentration of 8% would not pose a health hazard. 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 Ensulizole, or Phenylbenzimidazole Sulfonic Acid http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Phenylbenzimidazole Sulfonic Acid and its Potassium, Sodium and TEA salts are listed in the Cosmetics Directive of the European Union and may be used as UV filters in cosmetics and personal care products at a maximum concentration of 8% (expressed as acid) (see Annex VII).

Link to the EU Cosmetic Regulation: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

Health Canada permits the use of Phenylbenzimidazole Sulfonic Acid in sunscreen products at a maximum concentration of 8%.

More Scientific Information

Phenylbenzimidazole Sulfonic Acid and its salts are aromatic organic compounds. In cosmetics and personal care products, these ingredients function as sunscreen agents and as ultraviolet light absorbers. Phenylbenzimidazole Sulfonic Acid is water-soluble and is often used in sunscreen lotions or moisturizers so they will feel lighter on the skin and result in a non-greasy finish.

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

The European Commission’s Scientific Committee on Consumer Products (SCCP) opinion on Phenylbenzimidazole Sulfonic Acid and its salts. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_079.pdf

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/