More Australian Sunscreens Fail SPF Testing

The Therapeutic Goods Association continues to investigate concerns arising from recent Choice SPF testing of a range of sunscreens on the Australian market.

One of those sunscreens, Lean Screen, was voluntarily recalled due to a range of SPF testing results that were well below the claimed SPF of 50+, including test results showing an SPF as low as 4. Ultra Violette also voluntarily cancelled the listing of Lean Screen from the Australian Register of Therapeutic Goods.

According to TGA, Lean Screen was manufactured using the same base formulation as a number of other sunscreens. The manufacturer of that base formulation, Wild Child Laboratories Pty Ltd, received preliminary SPF testing results for that base formulation.

The preliminary testing indicates that this base formulation is unlikely to have an SPF greater than 21. Preliminary testing of specific goods manufactured using the base formulation indicate that the SPF value of the goods may, for at least some of the goods, be as low as SPF 4.

The TGA did not identify any manufacturing issue that would give rise to this result. The manufacturer has ceased manufacture and supply of the base formulation, according to TGA.

Testing Lab Concerns

The TGA is aware that each company that is responsible for an affected sunscreen will hold its own test results to substantiate the SPF claim for that sunscreen. However, as a part of the investigations into SPF sunscreen testing, TGA discovered “that some testing laboratories may be more reliable than others.” Advice for sponsors and manufacturers on SPF testing, and selecting an appropriate lab, can be found at Advice for sunscreen sponsors and manufacturers: Acceptance of additional SPF testing information.

In particular, TGA has significant concerns about the reliability of SPF testing undertaken by Princeton Consumer Research Corp (PCR Corp), a testing laboratory based in the United Kingdom. TGA is aware that many companies responsible for sunscreens manufactured using this base formulation relied on testing by PCR Corp to support their SPF claims, and that they obtained that testing before they were informed of TGA’s concerns.

The TGA outlined its concerns with PCR Corp testing to all companies responsible for sunscreens manufactured using this base formulation. The TGA has also written to PCR Corp regarding its concerns and has not received a response.

TGA noted that each company adds different types and amounts of excipients (like fragrances and color tints) to their base formulation. It is possible that the addition of excipients could increase or decrease the SPF of a sunscreen. TGA is, nonetheless, concerned that the test results relating to Lean Screen and the base formulation suggest that sunscreens made with the base formulation may not provide the claimed SPF.