Listed aerosol sunscreen products
As part of our normal review processes we are targeting aerosol sunscreens to check their efficacy.
Aerosol sunscreens are mixed with various propellants and are more dilute than lotion and cream sunscreens. This means you have to use more of an aerosol sunscreen to achieve the same coverage as lotion and cream sunscreens.
Sunscreen should always be applied according to the instructions for use on the label and following recommendations set out by:
Further information regarding aerosol sunscreen use can be found under Findings from TGA's compliance review of sunscreens.
Recently, a report was released by Queensland University of Technology regarding the propellant content and flow rates of some aerosol sunscreen products sold in Australia. The TGA will target a selection of aerosol sunscreens to review as the correct application of sunscreen is essential for its effective use.
Sponsors of aerosol sunscreens are expected to maintain appropriate records for demonstrating compliance of their sunscreens with regulatory requirements relevant to efficacy when used as intended.
What sponsors of existing listed medicines need to do
To prepare for a review of your aerosol sunscreen, you need to:
- Re-evaluate the sunscreen's presentation, including the label and any advertising material (including websites), particularly to check that your sunscreen's directions for use support sun protection claims.
- Have evidence to support the certifications of your sunscreen's efficacy when used as intended. See the Australian Regulatory Guidelines for Sunscreens (ARGS) for further information.
If your medicine is selected for review, you will receive a Request for Information notice. Further information about targeted reviews can be found under Listed medicines compliance reviews.
What the TGA will do
We will target a selection of aerosol sunscreens in the first quarter of 2022. These may be selected randomly or on the basis of regulatory intelligence (such as adverse event reports).
We will assess the sunscreen against listing requirements, with a focus on efficacy, including the directions for use.
If no compliance deficiencies are identified there will be no further regulatory action.
If deficiencies are identified the sponsor will be given opportunity to address them. If they cannot be sufficiently addressed enforcement actions (such as the cancellation of the medicine from the Australian Register of Therapeutic Goods (ARTG) and issuing of infringement notices) can be taken.
The outcomes from this targeted review will be published after the conclusion of the reviews.