PEG-25 PABA

What Is It?

PEG-25 PABA is an organic compound that absorbs ultraviolet (UV) light.

Why Is It Used?

In Europe, PEG-25 PABA 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 PEG-25 PABA 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, PEG-25 PABA 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

PEG-25 PABA, or Polyethylene Glycol (25) PABA, is a derivative of the commonly used sunscreen agent PABA, or para-aminobenzoic acid. PABA strongly absorbs UVB radiation and converts it into less damaging infrared radiation (heat). 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 Cosmetology (SCC) conducted a safety evaluation of PEG-25 PABA. 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 SCC concluded that Ethoxylated Ethyl-4-Aminobenzoate (PEG-25 PABA) was not allergenic or irritating. It was not genotoxic. The dermal absorption of this ingredient was low to moderate.

Link to the European Commission’s SCC opinion concerning PEG-25 PABA http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out05_e…

PEG-25 PABA 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

Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in PEG-25 PABA. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations.

Link to more information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane. http://www.cfsan.fda.gov/~dms/cosdiox.html

More Scientific Information

PEG-25 PABA is the polyethylene glycol derivative of PABA. In cosmetics and personal care products, PEG-25 PABA 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/