Australia proposes tougher sunscreen testing and limits on SPF claims

By Amara Osei

Ultra Violette’s Lean Screen SPF 50+ returned an SPF of 4 in Choice tests last year, and Australia’s Therapeutic Goods Administration (TGA) now proposes finished-product SPF testing at listing and periodically during ARTG registration.

Last year’s investigation by Australian consumer watchdog Choice found that several sunscreens returned SPF levels below those stated on their labels. Several brands pulled products from shelves, and the TGA launched an investigation.

The TGA identified that several other brands also used the base formula in Ultra Violette’s Lean Screen SPF 50+. The product returned the lowest SPF in Choice’s tests, just four, and was voluntarily recalled. Dozens of sunscreen products from a number of brands have since been recalled.

The TGA said the reforms will “ensure their quality, safety and efficacy to protect consumers from the sun’s harmful ultraviolet (UV) radiation, to reduce the incidence and impact of skin cancer”. The wider package seeks to improve the reliability of SPF claims and boost consumer trust.

Testing and laboratory controls

Under the proposal, sponsors may use in vitro and in vivo testing where appropriate. They would also have to provide their testing data to the TGA when a product is listed. The regulator would keep that information confidential.

SPF testing would be required on the finished product at listing and then periodically while the product remains in the Australian Register of Therapeutic Goods, or ARTG. Sponsors would therefore need to maintain performance evidence throughout ARTG registration.

The TGA also proposes stronger accreditation for testing laboratories. It would reference International Organization for Standardization (ISO) standards directly in legislation, placing the technical benchmarks within the regulatory framework.

Ingredient, claims and manufacturing controls

The TGA plans to develop quality requirements for specific sunscreen ingredients. The agency intends these requirements to ensure that products containing those ingredients are of high quality and perform as expected, adding an ingredient-level control to the reform package.

New limits on SPF claims for cosmetic sunscreens are also proposed. The objective is a clear distinction for consumers between sunscreens used primarily for UV protection and secondary, cosmetic sunscreens. Sponsors will need to assess how their existing product positioning and claims fit that division.

A review of sunscreen good manufacturing practice, or GMP, guidance would clarify expectations and responsibilities, strengthen manufacturing outcomes and support continued confidence in the quality and performance of sunscreen products in Australia.

What does this change for sunscreen sponsors?

For sponsors, the proposal creates an evidence chain extending from listing through ARTG registration. It also reaches laboratory selection, ingredient specifications, manufacturing controls and label review, although every measure remains at proposal stage.

• At listing: Sponsors would have to provide testing data when they list a sunscreen and could use in vitro or in vivo methods where appropriate. The TGA would hold the submitted information confidentially.
• After launch: Finished-product SPF testing at listing and periodically during ARTG registration would require a planned testing schedule rather than reliance on a single pre-launch result.
• For laboratory procurement: Stronger laboratory accreditation and direct ISO references in legislation would shape the choice of testing partners. Sponsors would need to check laboratories against the final accreditation requirements.
• For formulation and supply chains: Ingredient-specific quality requirements would add a specification layer. The GMP review could also change manufacturing controls and documentation for sponsors and their manufacturing partners.
• For claims and labels: New SPF-claim limits for cosmetic sunscreens would affect positioning and label review. The format for displaying SPF ratings remains unsettled pending further consultation.

Consultation and next steps

The proposals followed a three-month consultation earlier this year with industry, testing laboratories, health professionals, consumer groups, academia and other stakeholders. The process drew nearly 120 responses.

The TGA has not put forward a timeline for implementation. It says each reform “will take time to develop and will be implemented in a proportionate and targeted manner”. That leaves the order of the evidence, ingredient, claims and GMP changes open.

The regulator will also conduct a further review and consultation on SPF labelling. The earlier consultation produced mixed views on a proposal to change how SPF ratings appear on labels, so the display format remains unsettled.

Because the TGA has set no implementation timetable, the next checkpoint is its further SPF-labelling consultation; formulators and compliance teams still have no fixed date against which to schedule the proposed evidence work.