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How sunscreens are tested and regulated

The Therapeutic Goods Administration’s role regulating sunscreens

How sunscreens are tested and regulated

Sunscreens are therapeutic goods, designed to protect against UV radiation and reduce skin cancer risk.

That’s why it’s important the Therapeutic Goods Administration (TGA) has a strong and robust approach to regulating sunscreens.

The TGA ensures sunscreens in Australia are safe, effective and high quality so you can feel confident using sunscreens as one of five forms of sun protection.


The TGA encourages Australians to continue to use sunscreen. 


Sunscreens and SPF testing

Sunscreens sold in Australia are regulated by the Therapeutic Goods Administration (TGA). Product sponsors (the TGA’s term for sunscreen makers) and manufacturers must undertake testing at laboratories to prove sunscreen products offer the Sun Protection Factor (SPF) labelled.

The TGA is currently investigating inconsistencies in SPF testing results for a range of sunscreens on the Australian market, following the release of a report from consumer organisation CHOICE.

The regulator describes these inconsistencies as a “known issue”. That’s because it’s not uncommon for different labs to return different SPF results after testing the same sunscreen formula. However, it’s important to remember that SPF (Sun Protection Factor) number is a ‘guide’ (rather than a ‘measure’) of how well sunscreen protects the skin from sunburn.

When applied correctly, an SPF 30 sunscreen filters approximately 97% of UVB rays, while an SPF 50 sunscreen filters approximately 98%. The difference in protection between an SPF of 30 and 50 is small, and this difference becomes even smaller as the SPF value increases. Even an SPF 20 sunscreen still filters approximately 95% of UVB rays and therefore provides a much better level of sun protection than no sunscreen at all."

Therapeutic Goods Administration, 2025

Currently, the accepted methods in Australia for testing the SPF of sunscreens use human subjects. But testing on humans can be highly subjective and the response to a test can differ significantly from one individual to another.

Because of these limitations, the TGA review is exploring alternative testing methods that may be more reliable. But in the meantime, the TGA continues to encourage Australians to use sunscreens.

Given Australia’s high incidence of skin cancer, the TGA emphasises 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."

Therapeutic Goods Administration, 2025

You can stay up to date about the TGA’s role and regulation online.


Sunscreen product recalls

The recent recalls of sunscreen products that use the same base formula demonstrates strong and robust sunscreen regulation, is vital for maintaining consumer trust and confidence in sunscreens.

While variability in SPF test results is not uncommon, it is important swift action is taken where inconsistencies indicate a product may not provide safe levels of sun protection.

There are more than 900 sunscreens approved for sale in Australia by the TGA. You can check your sunscreen remains available on the TGA’s website.


So, what does this all mean right now?

Cancer Council continues to encourage regular sunscreen use because skin cancer remains the real danger. Australia has the highest rate of skin cancer in the world with 2 in 3 Australians diagnosed in their lifetime.

There is clear evidence demonstrating sunscreen's effectiveness in preventing skin cancer, but sunscreen should be the last line of defence. There are five vital steps of sun protection and Cancer Council encourages everyone in Australia to: Slip on clothing, Slop on sunscreen, Slap on a hat, Seek shade, and Slide on sunglasses whenever the UV Index is three or above.

What matters most is choosing a sunscreen you will use regularly and applying it correctly. Apply sunscreen 20 minutes before sun exposure, use a generous amount (at least 1 teaspoon for each limb, the front and back of the body and the face, including neck and ears), and reapply every two hours or immediately after swimming, sweating, or towel drying.


Information about Cancer Council sunscreens

Cancer Council understands you may have questions specifically about Cancer Council sunscreens. You can find more information here.

Get advice on how to protect your skin.