Suggestions in some media that the TGA does not adequately test sunscreens are incorrect

Recent media reports have expressed concern with the safety and efficacy of various sunscreen products and the testing process carried out by TGA on sunscreens available on the market

1 February 2017

Sunscreen testing

The TGA tests sunscreens in its laboratories using random samples of sunscreens from the market (pharmacies etc). Samples from the market reflect what is being applied to people and also enables us to look at stability if we need to.

The TGA does require sponsors to undertake SPF (efficacy) testing of sunscreens but because of the highly specialised nature of the testing the TGA does not do it in house. All testing is done under an international ISO standard.

If there was a problem with the SPF testing then all samples of that product would be affected and we would see much greater numbers of sunburn.

The Cancer Council and medical colleges have emphasised the importance of applying sunscreen liberally and regularly, as these products are commonly under-applied. Topically applied sunscreen products are also likely to be removed from the skin due to sweating, washing and being wiped by towel or clothing and must be labelled with the instruction 'to apply generously to the skin 20 minutes before skin exposure, then reapply frequently, and after swimming or towelling'; or words to this effect.

Adverse events to sunscreens

The majority of the Adverse Events reported to the TGA relate to allergic type reactions. The TGA undertakes toxicological (safety) assessment of these ingredients in accordance with the safety guidelines as covered in the Australian Regulatory Guidelines for Sunscreens. These safety reviews include assessment of the potential for sunscreen ingredients to cause skin irritation, corrosion or skin sensitisation.

It is possible that a small number of people may experience an adverse reaction to particular ingredients contained in topical medicines, insect repellents, cosmetics or sunscreen products. Given this it is advisable that, when first using a new product, to apply a small amount to a patch of skin first.

Safe effective protection

The balance of evidence relating to the use of sunscreens indicates that the ingredients used in sunscreens contribute to safe and effective protection from sun damage when used in accordance with the directions on the label.

The TGA continuously monitors the safe use of sunscreens, as well as the emerging scientific literature, and works cooperatively with international regulatory agencies. If concerns relating to the quality, efficacy or safety of a therapeutic product arise, the TGA can require that the product is removed from supply on the Australian market.