TGA developing reforms to strengthen sunscreen regulation

The Therapeutic Goods Administration (TGA) is progressing with the development of reforms to strengthen sunscreen regulation in Australia, following last year’s sun protection factor (SPF) testing scandal.

In mid-2025, laboratory testing initiated by CHOICE found that 16 out of 20 sunscreen products were failing to meet their stated SPF claims, with several so-called SPF 50 sunscreens returning results in the 40s, 30s, 20s and even as low as 4. In light of this, the TGA conducted a public consultation from March to May 2026, resulting in the proposed reforms to strengthen consumer confidence in sunscreen performance and ensure that sunscreen sponsors and manufacturers understand their regulatory obligations.

The most significant reform would require brands to test the SPF of their finished product, rather than just the base formula; to continue testing sunscreen periodically over its shelf life; and to provide their test results to the TGA on a confidential basis. The TGA has also proposed reviewing sunscreen Good Manufacturing Practice (GMP) guidance to strengthen manufacturing outcomes, as well as strengthening international accreditation of SPF-testing labs. More than half of the sunscreens that previously failed to meet their SPF label claims were tested in an overseas lab, which had its results called into question by experts.

On the flip side, companies would be allowed to test their products using an in vitro method, which involves testing sunscreen by putting sunscreen onto a plastic plate instead of human skin. Currently, products must be tested using in vivo test methods — which involve applying sunscreen to volunteers and measuring how effective it is under simulated sunlight UV exposure — but the TGA said it has concerns about variability in SPF testing results using the in vivo method.

The Public Health Association of Australia (PHAA) has thrown its support behind the TGA’s reforms, with CEO Terry Slevin — an Adjunct Professor at both Curtin University and ANU — saying the system for testing sunscreens in Australia has been problematic for some time.

“The TGA’s proposals are welcome and need to be worked through so that the testing is consistent and of high quality,” Slevin said. “It’s also important that this testing doesn’t increase the price of sunscreens.”

Slevin said epidemiological evidence shows that sunscreens are vital sun protection products, and a key part of a suite of skin cancer prevention measures.

“[But] sunscreen alone is not enough,” he said. “You also need to seek shade, wear protective clothing and a hat, and slide on sunglasses. And don’t forget to apply the correct amount of sunscreen on exposed skin 20 minutes before you head outside, and reapply it at least every two hours.”

Associate Professor Anna Wang, from UNSW Sydney, added that more stringent testing conditions will help make sure all our sunscreens can do what they promise, which is important given how many different formulations there are to choose from.

“But consumers shouldn’t get too caught up in the specific numbers because for most scenarios SPF 30 works as well to protect us as SPF 50 — there is a difference, but it is a pretty small one,” Wang said. “What is going to make a bigger impact isn’t whether a sunscreen tests SPF 45 using one method and SPF 40 using another, but how often we reapply, and whether we put the recommended amount on.

“The TGA’s proposed changes also aim to improve consumer understanding and behaviour around sunscreen use, and I welcome that.”

Image credit: iStock.com/CandyRetriever