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Australia: Sunscreen products withdrawn over incorrect safety ratings

Earlier this year the Therapeutic Goods Administration (TGA) halted the sale of 21 sunscreen products in Australia following reports from consumer advocacy group CHOICE that Sun Protection Factor (SPF) ratings on numerous sunscreens were incorrectly labelled.

The SPF number is the ratio of the time it takes for a light‑skinned person to burn while using the sunscreen, compared to the time it takes to burn without it.

CHOICE revealed in June that the SPF ratings of 16 of the 20 sunscreens it tested were well below their labelled claims. This poses serious risks of increased sunburn and melanoma, which is the most dangerous form of skin cancer and responsible for around 75 percent of deaths related to skin cancer.

Two in three Australians are expected to need treatment for various types of skin-related cancers in their lifetimes. According to Australian Institute of Health and Welfare estimates, over 1,450 people will lose their lives from melanoma this year, proportionally one of the highest rates in the world.

CHOICE called on the TGA “to urgently carry out its own sunscreen compliance testing and for the ACCC [Australian Competition and Consumer Commission] to investigate if any SPF claims are misleading.”

Ashley De Silva, who heads CHOICE, noted that the TGA relies on reports provided by the manufacturers themselves on the safety, quality and efficacy of their sunscreen products. These reports, he said, “may not be providing the accurate information consumers need when choosing sunscreens for themselves and their families.”

The most striking discrepancy that CHOICE’s testing revealed was for Ultra Violette Lean Screen SPF 50+ Mattifying Zinc Skinscreen, a $52 product, that had an SPF of just 4 instead of the advertised 50+. When the manufacturer rejected those results as “scientifically impossible,” the consumer advocacy group commissioned a second test from an independent German laboratory, which recorded an SPF of 5.

The base formula for Ultra Violette Lean Screen was manufactured by Wild Child Laboratories in Western Australia, the same formula being used in numerous sunscreen products sold nationwide, prompting a wider TGA intervention.

Wild Child CEO Tom Curnow told the media that the discrepancies were an “industry-wide issue,” rather than a specific fault in its manufacturing processes, adding that Princeton Consumer Research (PCR) had certified the product’s SPF 50+ rating.

The company, however, ceased manufacturing and supplying this base, and multiple affected products were recalled, withdrawn or placed under review while re‑testing was carried out by alternative laboratories.

The TGA conducted its own inspection of Wild Child’s Perth facility, with a focus on ingredient control, supplier qualification, manufacturing validation and in‑house testing linked to the disputed base formulation. It reported only “non‑serious” Good Manufacturing Practice (GMP) deficiencies and could not identify manufacturing problems that could explain the low SPF results.

Despite this, the TGA has kept open the possibility of regulatory action over sunscreens which used the base formula and that relied on data from the PCR.

An Australian Broadcasting Corporation (ABC) investigation later revealed that many sunscreen brands—including eight of those tested by CHOICE—relied on PCR for initial certification. PCR had also come under scrutiny from the “Truth in Advertising” group in 2024, and its work is now being questioned across several jurisdictions.

Two former senior staff at PCR—Brian Ecclefield (ex‑US business development manager) and Jane Tervooren (ex‑senior sales director)—told the ABC that they resigned over concerns about the accuracy and integrity of PCR’s SPF and other clinical testing.

Ecclefield said he repeatedly saw test results that were “too good to be true,” including a case where a non‑water‑resistant SPF 30 product somehow achieved a water‑resistant SPF 41.2 in PCR testing, which he considered implausible and a red flag for manipulated or flawed methods.

Internal emails obtained by ABC show PCR staff acknowledging that an incorrect “hybrid” method—mixing European protocol with US requirements—had been used in SPF studies, potentially inflating results, and that this may have been done for multiple sponsors without informing them.

Other internal emails show a PCR project manager warning that this incorrect method “has been completed for other sponsors in the past,” suggesting a pattern rather than a one‑off error. There is no evidence affected brands were proactively notified or their data corrected.

Jane Tervooren described being asked to unblind a double‑blind cosmetic trial by revealing which subjects had the real product versus placebo. This is a serious breach of good clinical practice and opens the door to biased or rigged outcomes.

While PCR says all its testing follows industry‑standard protocols, it has not provided a detailed, public methodological defence of the specific anomalies highlighted by whistleblowers and external experts.

The pattern that emerges is one in which manufacturers and regulators alike have relied on data whose accuracy is now in doubt, with potentially serious implications for consumer safety.

Separate to the Australian SPF dispute, Wild Child’s facility has been on a US Food and Drug Administration (FDA) Import Alert, or “red list,” since 2022, allowing American authorities to block its products at the border without physical examination because of a history of GMP violations.

FDA inspections between 2019 and 2024 reportedly identified systemic quality‑control failings, including poor investigation of product defects that could affect label accuracy and an internal case where an incorrect formulation leading to texture changes was treated as “cosmetic only” without further testing of its impact on claims.

According to ABC reporting, Wild Child products have been refused entry to the US multiple times, including as recently as March 2025, and the import alert remains in place while the FDA awaits evidence that manufacturing issues have been fully rectified. Wild Child’s chief executive has said the company has invested in a new “purpose‑built” facility and addressed the problems, but US restrictions have not yet been lifted.

These testimonies reinforced the view that the problems with SPF mislabelling extend beyond one or two products to the broader system of clinical testing on which regulators and companies rely.

Australian Federal Minister for Health Mark Butler, January 9, 2024 [Photo: Facebook/Mark Butler MP]

Questioned on Channel Seven’s “Sunrise” program in late October, Australian federal health minister Mark Butler downplayed the SPF mislabelling, insisting that the problem was caused by “just one ingredient” that had been tested by a “pretty bodgy” laboratory.

Butler claimed that regulatory authorities had addressed the issue, saying: “We’re very confident now that the products that you’ll see on the supermarket shelves are there with accurate testimony on their labels about their protection factor.” The TGA would “continue to monitor these products to make sure that the lab testing reflects the claim on the front of the bottle,” he said.

However, wrongly labelled sunscreens are not simply the result of failures by a few companies or testing facilities. The therapeutical regulatory system in which self‑policing increasingly dominates is itself flawed. TGA is responsible for ensuring the safety, quality and effectiveness of primary sunscreens sold in Australia and has enforcement powers, including ordering recalls and other measures. But it is not obliged to do preliminary testing of sunscreens, instead depending on post‑market surveillance.

Manufacturers are not required to get formal TGA pre‑approval before marketing their products. They only have to certify that their sunscreen meets all relevant local standards, by securing evidence from testing organisations to support their products’ SPF and performance claims.

Once these products go on sale, the TGA undertakes what it describes as post‑market surveillance, including reviewing adverse event reports, investigating consumer complaints, auditing manufacturers’ evidence and facilities, and targeted testing when concerns arise.

In other words, the TGA reacts after it receives complaints, rather than preventing problems before products reach consumers. This loose self‑regulatory process is not confined to Australia but is in line with procedures in the United States, the UK and the European Union.

Under these conditions, the manufacturers of sunscreens, pharmaceuticals and other health products, desperate to boost profits and driven by competitive pressures, routinely cut corners. The reliance on private laboratories such as PCR, which are themselves competing for contracts, creates further incentives to deliver favourable results for sponsors, rather than rigorous and transparent science.

Butler’s assertion in October that the sunscreen problems were under control was contradicted the following month by further TGA recalls following revelations about sunscreen manufacturing faults. In November, five of Bondi Sands’ sunscreen products were withdrawn due to the liquid formula “splitting into layers.”

When this occurs, the medicinal ingredients responsible for UV protection are no longer evenly distributed, thus compromising their official SPF ratings. Early this month, the TGA issued an urgent recall for three specific batches of the Cancer Council’s Clear Zinc Kids SPF 50+ sunscreen, also due to potential formula separation problems.

The Cancer Council product had been previously singled out in CHOICE’s earlier report for failing to reach its claimed SPF 50+ in independent testing, instead returning an SPF rating of 33. Although the reasons for the latest recalls differ from the earlier recalls that contained the Wild Child formula tested by PCR, the latest announcements have added to increasing popular concerns about the reliability of current sunscreens.

The false labelling and physical failure of sunscreens—now including Cancer Council’s own children’s product—demonstrate that these issues are not the failure of a few companies or testing facilities but inherent features of a system that promotes self‑regulation, undermining accurate scientific testing and encouraging opaque procedures that prioritise profit over human life and threaten public health.

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