By Kayla Olaya and Penry Buckley
The medicines regulator has recommended dozens of popular sunscreen manufacturers reformulate their products to add safeguards concerning two active ingredients weeks after a controversial report.
Companies that produce sunscreens containing the ingredients homosalate and oxybenzone, as well as benzophenone – a by-product produced as some sunscreens degrade – may be forced to reformulate their products after the Therapeutic Goods Administration (TGA) said sunscreens must “meet the highest standards of safety for prolonged and frequent use”.
The recommendation follows a controversial report that claimed several brands had failed to meet sun protection factor (SPF) rating claims.Credit: Getty Images
However, the TGA – the regulator responsible for the sale of sunscreen and medicines – said that the recommendations do not mean current Australian sunscreens containing those ingredients are unsafe.
“All sunscreens available in Australia are safe. The TGA is not recommending a change in the use of sunscreens, nor are there any warnings, bans or recalls of any products,” it said.
A review conducted by the regulator found that of the seven active sunscreen ingredients tested, homosalate and oxybenzone were at a lower margin of safety when using the highest-estimated sunscreen exposure for application.
“Based on the data considered in this safety review, the TGA recommends regulatory controls for homosalate and oxybenzone to restrict their permitted concentrations and use in therapeutic sunscreens,” it said in a statement.
Some of the sunscreens potentially affected
- Woolworths SPF 50+ Everyday Sunscreen – Active ingredient: Homosalate
- Banana Boat SPF 50+ Sport – Active ingredient: Homosalate
- Cancer Council SPF50+ Sport Dry Touch – Active ingredient: Homosalate
- Coles SPF 50+ Sunscreen Ultra Tube – Active ingredient: Homosalate
- Nivea Sun UV Face Sunscreen Shine Control SPF50 – Active ingredient: Homosalate
- Bondi Sands SPF 50+ Coconut Beach Sunscreen Lotion – Active ingredient: Homosalate
- La Roche-Posay Anthelios Wet Skin Sunscreen SPF 50+ – Active ingredient: Homosalate
The main adverse health concern is that the ingredients can potentially act as endocrine disruptors (chemicals that interfere with the body’s hormones), however the TGA says available scientific data is not yet “adequate to derive a conclusion as to their causality in humans”.
Cosmetic chemist Dr Michelle Wong reinforced the regulators’ message to consumers to continue using current sunscreens at home, saying that the review aims to make already safe sunscreens safer.
“These are little regulatory changes in the background that are making products that are very safe even safer. It’s not really a red flag for consumers to worry about, but it is something that manufacturers will have to worry about because they’re going to have to reformulate some of their sunscreens,” she said.
Homosalate, which can be found in the ingredient lists of most sunscreens on chemist shelves, is present in some sunscreen products from popular brands, including Banana Boat, Cancer Council, Coles, Woolworths, Nivea, Neutrogena and La Roche-Posay.
The brands have been approached for comment. Coles and Woolworths will work with its sunscreen supplier to ensure compliance with applicable regulatory changes.
The announcement follows a review of ingredients used in Australia by the regulator in February, as well as the adoption of a new model to understand how often Australians are exposed to the ingredients in the sunscreen they use, and regulatory changes overseas.
The European Union published opinions on the safety of oxybenzone and homosalate in 2020-21, which found levels in the European market were not safe.
Oxybenzone, which is currently restricted to 6 per cent in sunscreens in Australia, the US and Canada, and for face, hand and lip products in Europe, is now restricted to 2.2 for body products in the EU.
As of January 1, 2025, homosalate, which is limited to 15 per cent in Australia, the US and Canada, is restricted to 7.3 per cent in sunscreens in the EU. Benzephenone has been banned as a cosmetic ingredient in the EU, which has also implemented requirements that the product, which is also produced as other sunscreen ingredients degrade, be kept “at trace level”.
The regulator invited public and key stakeholders to a consultation on Tuesday to help determine the safe level of use of these ingredients, which closes on August 12. Nivea’s parent company, Beiersdorf Australia, said it will participate in the consultation process and provide feedback regarding the proposed amendments.
It comes after consumer advocacy group Choice released the lab results of its contentious sunscreen tests, which claimed the likes of Ultra Violette, Cancer Council, Bondi Sands and Banana Boat had failed to meet SPF rating claims of 50 or higher. These brands said independent testing showed compliance with their labelled rating, with some submitting products for additional tests.
The TGA is now investigating Choice’s findings.
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