Polysilicone

What Is It?

Polysilicone-15 is an organic compound that absorbs ultraviolet (UV) light.

Why Is It Used?

In Europe, Polysilicone-15 is an approved UV filter, which means the 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 Polysilicone-15 has not yet been reviewed for sunscreen use by the FDA and it cannot be used in sunscreen drug products.

For cosmetics in the United States, Polysilicone-15 can be used as a UV light absorber. In this case, the ingredient serves to protect the product from deterioration by absorbing, reflecting, or scattering UV light.

Scientific Facts

Polysilicone-15 is a broad spectrum UV absorber and a photostabilizer. UV radiation is an important cause of 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 Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) conducted a safety evaluation of benzylidene malonate polysiloxane (Polysilicone-15). Based on their review, they 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 Commission’s SCCNFP concluded that dermal absorption of benzylidene malonate polysiloxane (Polysilicone-15) was very low (2%), there was no evidence of sensitization, irritation or photoallergenicity. The ingredient was not mutagenic and no clinical abnormalities were seen after acute, subchronic or chronic testing.

Link to the European Commission’s SCCNFP opinion concerning Polysilicone-15: http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out56_e…

Polysilicone-1 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% (see Annex VII).

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm

Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) considered the available data on Polysilicone-15 and concluded that there is negligible concern to public health based on its reported use pattern.

http://www.nicnas.gov.au/publications/car/new/sanhp/sanhpsummr/sanhp3.asp

More Scientific Information

Polysilicone-15 is a siloxane polymer composed of alternating silicon and oxygen monomers. In cosmetics and personal care products, Polysilicone-15 functions as a UV 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/