The TGA is aware of a CHOICE report where a number of sunscreens were found to not meet their claimed Sun Protection Factor (SPF) ratings. SPF indicates how effective the sunscreen is against sunburn from the sun's Ultraviolet (UV) radiation.
In Australia, sunscreens are regulated as either cosmetics or therapeutic goods depending on a number of factors, such as their ingredients, health claims and claimed SPF. Sunscreens with a primary purpose of UV protection are considered to be therapeutic goods and are regulated by us to ensure their safety, quality and efficacy.
It is a requirement under therapeutic legislation that statements on sunscreen labels are truthful and not misleading. It is also a legislative requirement that a sponsor of a therapeutic sunscreen product holds evidence that supports the SPF claim they make at the time they include the medicine in the Australian Register of Therapeutic Goods (ARTG).
We will be investigating the CHOICE findings and will take regulatory action as required. While the TGA has powers under the Therapeutic Goods Act 1989 to release certain information to the public, and does so in appropriate cases, the TGA does not generally publicly comment on investigations or compliance action in individual matters until they are concluded, as doing so may compromise the investigation.
Given Australia's high incidence of skin cancer, the TGA reiterates that using sunscreen is an important measure to prevent harmful effects of ultraviolet radiation, in addition to seeking shade, wearing a wide-brimmed hat, wearing protective clothing and using sunglasses.
We note that several of the products in the CHOICE report provided results in the range of SPF 30. Consumers are advised that SPFs in the range of 30 to 59 provide 'High protection', while a SPF of 60 or higher (SPF 50+) provides 'Very high' protection. Therefore, products with an SPF of 30 are effective to use.
In relation to testing requirements, all sunscreens in Australia must comply with the testing and labelling requirements in the Australia/New Zealand standard for sunscreens, which incorporates internationally recognised ISO standards.
Currently, the internationally accepted ISO method of sunscreen SPF testing [(ISO 24444:2019, Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF)] uses human subjects. It is a known issue that there is variability in SPF testing results across laboratories because testing on humans can be highly subjective and the response to a test can differ dramatically from one individual to another. While progress is being made internationally toward in-vitro sunscreen testing (e.g. not on human subjects), which will improve consistency of results, these methods are not yet in place.
The TGA does not conduct human or animal testing, so where necessary, the TGA can outsource SPF testing to 3rd party laboratories The TGA can conduct other testing of sunscreen products in-house, such as laboratory broad spectrum performance testing as per the Australian Standard (AS/NZS 2604), and content of the active ingredient testing.
