Drometrizole Trisiloxane

What Is It?

Drometrizole Trisiloxane is an organic compound that absorbs ultraviolet (UV) light.

Why Is It Used?

In Europe, Drometrizole Trisiloxane is an approved UV filter, 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 Drometrizole Trisiloxane 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, Drometrizole Trisiloxane can be used as a ultraviolet light absorber. In this case, the ingredient serves to protect the product from deterioration by absorbing, UV light.

Scientific Facts

Drometrizole Trisiloxane UV radiation which is an important cause of sunburn, premature aging of the skin and in the development of melanoma and other forms of skin cancer.

Safety Information

The European Commission’s Scientific Committee on Cosmetology (SCC) conducted a safety evaluation of Drometrizole Trisiloxane. Based on their review, they concluded that use of this ingredient in cosmetic products as a UV light absorber at a maximum concentration of 15% would not pose a health hazard.

The European SCC concluded that there was no evidence of allergenicity or mutagenicity of Drometrizole Trisiloxane. Dermal absorption was found to be very low.

Link to the European Commission’s SCC opinion concerning Drometrizole Trisiloxane: http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out03_e…

Drometrizole Trisiloxane 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 15% (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

Drometrizole Trisiloxane is a heterocyclic compound. In cosmetics and personal care products, Drometrizole Trisiloxane functions as an ultraviolet light absorber. UV absorbers, like sunscreen agents, have the ability to convert UV radiation into less damaging infrared radiation (heat).


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/