Disodium Phenyl Dibenzimidazole Tetrasulfonate
What Is It?
Disodium Phenyl Dibenzimidazole Tetrasulfonate is an organic compoundA compound that contains carbon and hydrogen and usually other elements such as nitrogen, sulfur and oxygen. that absorbs ultraviolet (UV) light.
Why Is It Used?
In Europe, Disodium Phenyl Dibenzimidazole Tetrasulfonate is an approved 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., which means that this ingredient can be added to sunscreen products that are designed to protect the skin from the sun. In Europe, sunscreen products are considered cosmetic products. In the United States, sunscreen products are Over-the-Counter (OTC) drugs and only certain ingredients have been approved by the Food and Drug Administration (FDA) for use in these products. In assessing sunscreen active ingredients, the FDA reviews both safety and efficacy.
The safety and efficacy of Disodium Phenyl Dibenzimidazole Tetrasulfonate has not yet been reviewed for sunscreen use by the FDA and it cannot be used in sunscreen drug products. For cosmetics and personal care products in the United States, Disodium Phenyl Dibenzimidazole Tetrasulfonate can be used as an ultraviolet light absorberIngredients that protect cosmetic products or packaging from deterioration by absorbing, reflecting, or scattering UV rays. These ingredients may also be used to protect the hair from UV rays. See also UV Filters.. In this case, the ingredient serves to protect the product from deterioration by absorbing UV light.
Scientific Facts
Disodium Phenyl Dibenzimidazole Tetrasulfonate is a broad spectrum UV absorber, absorbing UVB as well as UVA rays. UV radiation is an important cause of sunburn, premature aging of the skin and contributes to the development of melanoma and other forms of skin cancer.
Safety Information
The European Commission’s Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) conducted a safety evaluation of Disodium Phenyl Dibenzimidazole Tetrasulfonate.
Based on their review, the SCCNFP concluded that use of this ingredient in cosmetic products as a UV light absorber at a maximum concentration of 10% would not pose a health hazard.
The European SCCNFP concluded that there was no evidence of allergenicity or irritation of Disodium Phenyl Dibenzimidazole Tetrasulfonate. This ingredient was not genotoxic and did not cause toxicity after acute, subchronic or chronic administration.
Link to the European Commission’s SCCNFP opinion Disodium Phenyl Dibenzimidazole Tetrasulfonate http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out53_e…
Disodium Phenyl Dibenzimidazole Tetrasulfonate 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% (of acid) (see Annex VII).
Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm
More Scientific Information
Disodium Phenyl Dibenzimidazole Tetrasulfonate is a heterocyclic compound. In cosmetics and personal care products, Disodium Phenyl Dibenzimidazole Tetrasulfonate functions as an ultraviolet light absorber. UV absorbers, like sunscreen agents, have the ability to convert UV radiation into less damaging infrared radiation (heat).
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 FDA 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/