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TGA Proposes Reformulating Sunscreens and Opens Stakeholder Consultation

The regulator will gather feedback through August 12 following updated safety reviews that highlighted low safety margins for key sunscreen chemicals

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Australia's medicines watchdog has begun a public consultation after finding some sunscreens may need reformulating to lower levels of three ingredients.

Overview

  • TGA recommended reformulating sunscreens containing homosalate, oxybenzone and benzophenone to meet higher safety standards for prolonged and frequent use.
  • The safety review found homosalate and oxybenzone had lower margins of safety at the highest estimated exposure and noted potential endocrine-disruption concerns without conclusive human data.
  • All sunscreens currently available in Australia remain safe with no warnings, bans or recalls in effect, the TGA affirmed.
  • A public and industry consultation on safe concentration thresholds for the three ingredients runs until August 12 before final controls are set.
  • Manufacturers, including Bondi Sands, Banana Boat and Cancer Council, are evaluating product reformulations in response to EU limits, domestic exposure modeling and Choice’s SPF testing findings.