TGA's compliance review of sunscreens

In May 2017, we published the laboratory testing results of 31 commonly used sunscreens. These included lotions, creams and aerosol sprays sourced from Australian pharmacies and supermarkets. All of the products tested contained the levels of active ingredients specified on their labels.

We have since completed a desktop review of 94 listed sunscreen products, which provides us with a snapshot of the quality, safety and efficacy of sunscreens on the Australian market. During this process, TGA staff reviewed product labels, manufacturing and formulation data, and sun protection factor (SPF)-testing data provided by the sponsor. This helped us to determine whether these sunscreens met relevant regulatory requirements under the Therapeutic Goods Act 1989, including the Australian and New Zealand Sunscreen Standard (2012).

Key findings

• We found no compliance deficiencies that concern us in relation to quality, safety and efficacy in every-day use.
• We identified no sensitivity issues based on the amounts of the ingredients they contain compared to regulatory requirements, but emphasise that:
  • Some individuals may be sensitive to ingredients found in sunscreens.
  • Side effects, such as allergic reactions are possible. This is true for any cosmetic, medicines, skin treatment and some foods.
  • Consumers are encouraged to perform a test on a small patch of skin prior to use.
• SPF - testing data supported SPF claims on aerosol sunscreens, but TGA lab testing confirms that application remains an issue:
  • Sunscreen is only effective if applied correctly and thoroughly.
  • The quantity of product delivered and the amount lost into the atmosphere during aerosol application varies between brands.

Key messages

• Consumers can have confidence in the sunscreen products currently available on the Australian market when used as directed on the label.
• Apply sunscreen liberally (at least 1 teaspoon/5 ml) to each area (arm, leg, back, etc.) for full coverage and effectiveness.
• Re-apply sunscreen regularly (every two hours), following instructions on the label - especially after swimming or towelling.
• Water activities or activities that may cause perspiration require more frequent application.
• Sunscreen products do not block 100% of UV radiation. You will become sunburnt if your skin is exposed to the sun for extended periods.
• Sunscreens are regulated as medicines. Consumers should report side effects directly to the TGA.

Further information about the safe and effective use of sunscreens can be found on our compliance review web page.