Australia has one of the highest rates of skin cancer in the world. Around 2,000 Australians die each year from melanoma and related conditions. Sunscreen is not just a consumer product in this context, it is a frontline public health intervention.

So when confidence in sunscreen performance is questioned, the implications extend far beyond the cosmetics aisle.

The Therapeutic Goods Administration (TGA) has now opened a national consultation on improving the regulation of sunscreens. It is a timely and necessary step, prompted by a convergence of scientific, regulatory and consumer concerns that have exposed weaknesses in the current framework.

A System Under Pressure

Australia’s regulatory model for sunscreens has long been considered robust. Therapeutic sunscreens are regulated as listed medicines, enabling timely market access while relying on post-market surveillance to ensure compliance.

But that balance is now being tested.

According to the TGA consultation paper, variability in SPF testing, limited oversight of testing laboratories, and inconsistencies in labelling and claims have emerged as key issues.

The challenge is structural. Sunscreens are largely assessed through sponsor certification rather than pre-market evaluation. While this supports innovation and access, it also creates reliance on the integrity of testing and the quality of evidence held by sponsors.

Recent developments have brought these vulnerabilities into sharper focus.

The consultation notes that independent testing and media investigations have raised concerns about whether some products meet their claimed SPF levels.

This is not a marginal issue. SPF is the central metric by which consumers judge protection. If it cannot be relied upon, the entire system is undermined.

The Confidence Gap

Stakeholders across the sector have responded strongly to the consultation.

consumer advocacy has played a critical role in catalysing reform. As noted:

These perspectives highlight a common theme: the system is no longer delivering the level of assurance that consumers expect.

What the TGA Is Proposing

The consultation outlines a series of potential reforms aimed at strengthening the regulatory framework without unnecessarily constraining innovation.

Key areas include:

• Improving the reliability and transparency of SPF testing

• Adopting new testing technologies more rapidly

• Strengthening oversight of testing laboratories

• Enhancing lifecycle quality assurance through periodic testing

• Simplifying SPF labelling

• Aligning claims between therapeutic and cosmetic sunscreens

• Updating Good Manufacturing Practice guidance

These are not incremental tweaks. They go to the core of how sunscreen performance is measured, verified and communicated.

One of the most significant areas under review is SPF testing itself.

The current gold standard, an in vivo method using human subjects has known variability issues and raises ethical concerns. The emergence of new in vitro methods presents an opportunity to improve reproducibility and reduce reliance on human testing.

However, transitioning to new methods is not straightforward. It requires changes to standards, legislation, and industry practice.

This highlights a broader regulatory challenge: how to remain responsive to scientific advances in a system that is, by design, cautious and consultative.

Beyond SPF: A More Complex Risk Landscape

The consultation also reflects a shift in how sunscreen performance is understood.

SPF primarily measures protection against UVB radiation, the cause of sunburn. But UVA radiation, which penetrates deeper into the skin, contributes to ageing and long-term damage, including cancer.

An overreliance on SPF as a single metric risks oversimplifying this complexity.

The Australian Sunscreen Council’s call to move beyond “UVB-centric SPF labelling” speaks to this issue directly. It suggests a future where sunscreen performance is communicated in a more holistic way, reflecting both UVA and UVB protection.

At the same time, ingredient safety remains under scrutiny, with ongoing reviews into substances such as homosalate and oxybenzone. While these are being addressed through separate processes, they contribute to the broader narrative of increasing regulatory attention.

A Turning Point for Regulation

What emerges from this consultation is not just a technical review, but a broader inflection point for sunscreen regulation in Australia.

The current framework has delivered accessibility and market growth. But it is now being asked to deliver something more: demonstrable, verifiable trust.

The TGA itself acknowledges that continuing to rely on case-by-case investigations is not sustainable:

This is a clear signal of intent.

What This Means for the Sector

For industry, this consultation represents both risk and opportunity.

There will be increased scrutiny of testing methods, laboratory practices, manufacturing standards and claims.

But there is also an opportunity to reset the narrative.

Sunscreen is one of the most widely used therapeutic products in Australia. Strengthening its regulatory foundations strengthens public confidence not only in these products, but in the broader regulatory system.

For professionals across regulatory affairs, quality, clinical and manufacturing, this is a moment to engage.

Because this is not just about sunscreens.

It is about how we ensure that products designed to protect health actually deliver on that promise—and how we demonstrate that they do.

The Bottom Line

Australia’s sunscreen regulatory framework is being asked to evolve.

The science has moved. Consumer expectations have shifted. And recent evidence has exposed gaps that can no longer be ignored.

The consultation is an important step, but it is only the beginning.

The real test will be whether the system that emerges is not only more robust, but more trusted.

Because in a country like Australia, trust in sunscreen is not optional.

It is essential.