For Immediate Release: Australian Sunscreen Council Investigation Reveals 21 'Grandfathered' Sunscreen Ingredients Lack TGA Safety Assessments

29/09/2025 – Following an extensive investigation based on Freedom of Information (FOI) requests, the Australian Sunscreen Council (ASC) has today revealed significant public health concerns regarding the regulatory oversight of sunscreen ingredients in Australia. The investigation confirms that 21 active sunscreen ingredients currently permitted for use have never undergone a modern safety and efficacy assessment by the Therapeutic Goods Administration (TGA).

Internal TGA documents describe these ingredients as having been "grandfathered" onto the permissible list prior to the introduction of modern regulatory standards. This has allowed them to remain on the market without the TGA holding a compliant safety assessment on file to validate their safety for public use.

Furthermore, the TGA's own internal reviews, released via the FOI process, identified only Zinc Oxide as an active ingredient without safety concerns—a conclusion that directly aligns with the analysis of the United States Food and Drug Administration (FDA). The ASC questions the decision to withhold this critical conclusion from the Australian public, which has consequently been using products with active ingredients that the regulator itself does not consider to be without risk.

The FOI documents also confirm the involvement of Accord, the industry body for chemical manufacturers and suppliers, in TGA meetings. Faced with the reality that the ingredients their members are using are considered unsafe, they appear to be pressuring the TGA to change the fundamental safety requirements. Instead of proving an ingredient is safe before it can be used on the public, they are lobbying for a model that allows use on the public without safety data, shifting the burden of proof to others to fund studies to prove it is unsafe.

The regulatory inaction is exemplified by ingredients like 4-Methylbenzylidene Camphor (4-MBC). The only TGA file note from 2005 indicates a plan to "follow the EU's lead." The TGA has not reassessed its safety in 20 years, during which time the EU, Japan, and the US have banned it. Crucially, because Australians use far more sunscreen than consumers in the EU, what is considered to have an unacceptable safety margin overseas is far worse for the Australian public. The TGA's own advice for reapplication every two hours means Australians may apply at least four times the amount of sunscreen as the average European, dramatically increasing their exposure to these unassessed chemicals.

Another alarming example is Trolamine Salicylate. The TGA has implemented an internal ban on its use due to safety concerns, yet has publicly kept it on the permissible ingredients list. This appears to be a deliberate effort to bolster the public claim that there are no safety concerns with sunscreens, while their internal actions prove the opposite is true.

"The integrity of Australia’s regulatory framework for sunscreens is predicated on robust, evidence-based safety assessments," said an Australian Sunscreen Council spokesperson. "Our findings indicate that for these 21 ingredients, this fundamental requirement has not been met. This is not a matter of debate; it is a matter of public safety and regulatory transparency."

The ASC's Position:

The Australian Sunscreen Council calls for immediate and decisive action from the TGA, including:

1. Immediate Suspension: The TGA must immediately suspend the listing of all 21 of these ingredients on the permissible ingredients determination until they can go through the correct safety assessment process every other ingredient must follow according to the Therapeutic Goods Act.

2. Public Health Announcement: The TGA must formally inform the public that Zinc Oxide is the only broad-spectrum UV filter that both it and the US FDA consider safe and effective without other concerns.

3. Full Investigation: An independent investigation must be launched into why this regulatory failure was allowed to happen, why it was kept hidden from the public for over 20 years, and why legislated requirements were ignored.

4. Correction of Public Advice: The TGA must remove all current sunscreen safety advice from its website and issue public corrections to be transparent with the Australian people and begin the process of rebuilding trust.

The 21 "grandfathered" active ingredients that have not been assessed for safety and efficacy by the TGA are:

• 4-Methylbenzylidene Camphor (4-MBC)

• Benzylidene Camphor Sulfonic Acid

• Butyl Methoxydibenzoylmethane (BMDM)

• Camphor Benzalkonium Methosulfate

• Cinoxate

• Dioxybenzone

• Ecamsule

• Ethylhexyl Triazone

• Homosalate

• Isoamyl Methoxycinnamate

• Menthyl Anthranilate

• Octyl Methoxycinnamate

• Octyl Salicylate

• Octocrylene

• Oxybenzone

• Padimate O

• PEG-25 PABA

• Phenylbenzimidazole Sulfonic Acid

• Sulisobenzone

• Sulisobenzone Sodium

• Trolamine Salicylate

Media Enquiries:

All general media enquiries should be directed to: media@australiansunscreencouncil.org

For specific questions regarding Australian regulation and safety, enquiries will be referred to:

Dr. Yousuf MohammedDeputy Director CMM, AIBN Building, The University of QueenslandChair - American Association of Pharmaceutical Sciences, Topical Transdermal community (TTC)Associate Professor, School of Pharmacy and Pharmaceutical Sciences, The University of Queensland

For enquiries relating to the potential adverse effects of petrochemical sunscreen use and their impact on the population, enquiries will be referred to:

Dr. Denis Dudley, MD Board-Certified OB-GYN, Reproductive Endocrinologist & Mineral Sunscreen Pioneer. With 103 publications and 757 citations, Dr. Dudley is a leading expert with over 30 years of experience in the field.

TGA FOI Disclosure Log: Accord Industry Body TGA Correspondence FOI 25-0169

TGA FOI Disclosure Log: Draft Sunscreen Ingredient Safety Review (Before the statement that both Oxybenzone and Homosalate presented an immediate risk to the public was deleted.) FOI 25-0104

TGA FOI Disclosure Log: Response to request for all Safety Assessments on File for UV filters FOI 25-0009

TGA FOI Disclosure Log: Query from Cancer Council Australia top TGA around safety of 4-MBC given EU and US have banned it. TGA confirm they have asked their Tox team to review, but have no date of when that will take place. FOI 25-0017

TGA FOI Disclosure Log: Internal TGA Correspondence Banning Trolamine Salicylate FOI 25-0010 - 1.PDF