Testing for benzene in aerosol sunscreen products being supplied in Australia

Sunscreens contain substances that either absorb or reflect the sun's ultraviolet (UV) rays to prevent them from penetrating the skin and damaging skin cells. Only approved ingredients can be included in sunscreens, and each of these ingredients has been assessed for safety.

The TGA regulates sunscreen products to ensure they meet the high standards for quality, safety and effectiveness in the guidance Understanding the regulation of therapeutic sunscreens (previously the Australian regulatory guidelines for sunscreens). This includes actively monitoring products on the market through both laboratory testing and compliance reviews.

Background

In response to reports of contamination of aerosol sunscreens with benzene, the TGA Laboratories have tested a range of these products currently supplied in Australia. Benzene is classified as a human carcinogen, a substance that could potentially cause cancer depending on the level and extent of exposure. It is not an ingredient in sunscreens but is suspected to be a contaminant from raw materials used in product manufacture.

The purpose of this testing was to determine if benzene was present in these sunscreens and to quantify the amounts present. The outcome of the testing is available in the table below.

The levels of benzene must be below 2 parts per million (ppm) in sunscreen products that are regulated as listed medicines in Australia. We use a very conservative approach to set limits for benzene and similar chemicals. They are calculated to ensure that an individuals' excess cancer risk would not exceed 1 in 100,000 if that individual used the maximum recommended amount of the product every day of the year for 70 years.

Testing results and actions

Aerosol sunscreen products were obtained from Sponsors by the TGA. The samples for this initial round of testing were targeted to cover different sponsors and manufacturers. In some cases, the aerosol sunscreen products were purchased online.

The testing was performed using a validated headspace gas chromatography tandem mass spectrometry method (HS-GC-MS/MS).

Testing has been finalised on 18 products with three products found to contain unacceptable levels of benzene above the 2 ppm limit (two different lots of one product were tested). The products were Banana Boat products from the sponsor Edgewell Personal Care Australia Pty Ltd.

In consultation with the TGA, Edgewell has taken a precautionary approach and commenced a recall of all batches of these three products from the Australian market.

Consumers are advised to discard the products and visit the Banana Boat website to request a refund. If consumers have any questions, we advise them to contact the Edgewell Personal Care Consumer Service team (Free Call) on 1800 761 186. Further information about the recall of these products is available on the TGA website.

Further data will be provided when testing results from other products are available.