Listed aerosol sunscreen products

In 2022, we initiated targeted post market compliance reviews of aerosol sunscreens to check their efficacy. We found that some sunscreens had clear label directions for safe and effective use, while others were required to change their directions. One product was recalled for directions promoting application on the face, posing a risk of inhalation. 

To obtain the sun protection factor (SPF) claimed on the label, the TGA recommends that consumers apply the product according to the directions for use and follow the recommendations by the Cancer Council and Australasian College of Dermatologists.

What led to this review

Sunscreens regulated as therapeutic goods in Australia are included in the Australian Register of Therapeutic Goods (ARTG) as low risk listed medicines. These medicines may be subject to a post-market compliance review at any time while they remain in the ARTG. This allows us to determine if these products are compliant with relevant regulatory requirements.  

Reports from Queensland University of Technology (QUT) and Griffith University examined the propellant content, flow rate, as well as climactic factors of some aerosol sunscreens that may impact their application in Australia.

The reports highlighted the aspects unique to aerosol sunscreens, such as how the dosage form could impact their effectiveness. As a result, the TGA targeted a selection of listed aerosol sunscreens to check their efficacy. 

What we did

We identified 19 sunscreens listed in the ARTG that used an aerosol dosage form. Sponsors, of these sunscreens, were asked to provide evidence to demonstrate their products’ ability to safely and effectively deliver the SPF claimed on their product labels. 

What we found

The sponsors of all 19 listed aerosol sunscreens responded to our request for information. 

Following our review of these products, 13 aerosol sunscreens remain listed in the ARTG. These sunscreens were found to have appropriate evidence to support the SPF claimed on the label.

Additionally:

• 7 carried clear and adequate directions for use on their label and no action was required by the sponsor.
• 6 required amendments of the directions for use on the label to support consumers to obtain safe and effective sun protection.

Six sunscreens were cancelled from the ARTG at the request of the sponsor:

• 3 were cancelled after receiving the TGA’s initial request for information.
• 3 were cancelled after the TGA sent the sponsor a letter detailing the compliance deficiencies identified for their sunscreen. One of these sunscreens was also recalled as it promoted direct application on the face, which represented an inhalation risk.

The compliance review results for each sunscreen are published on the Listed medicine compliance reports.

Information for consumers

If you choose to use aerosol sunscreens as part of your overall sun protection routine, we recommend you follow these directions for safe and effective use.

Are you using aerosol sunscreen properly?

Aerosol sunscreens are popular as they offer a quick and easy way to apply sunscreen. However, it is important to use them the right way to avoid sunburn and other problems. 

Here’s how to use them safely:

1. Hold the container 10 to 15 cm away from the body and apply liberally and evenly until the product looks and feels wet on the skin. 
2. Do not spray directly onto the face. Spray onto hands and then apply to the face. 
3. Do not apply the product in windy conditions. 
4. Use in a well-ventilated area and avoid inhalation.

These instructions will be required on all aerosol sunscreen labels in Australia soon.

Following these steps will help you get the full sun protection the product offers, and reduce the risk of inhaling the spray or getting it in your eyes.

Stay Sun Smart

Remember, sunscreen shouldn’t be your only defence against the sun’s harmful UV rays. The Cancer Council recommends a few steps to help protect yourself:

• slipping on sun protective clothing

• slopping on SPF30 or broad-spectrum water-resistant sunscreen

• slapping on a broad brim hat

• seeking shade when possible

• sliding on sunglasses

For more tips on using sunscreens and staying sun smart visit the Cancer Council website. 

Information for sponsors

Sunscreen labels must have clear and adequate directions to ensure safe and effective sun protection. The Australian/New Zealand Standard Sunscreen products – Evaluation and classification AS/NZS 2604:2021 Amd 1:2022 (the 2021 Sunscreen Standard) introduces requirements for clear label instructions for aerosol and spray pump sunscreens. The TGA will adopt this standard into therapeutic goods legislation in July 2024. For more information, visit the Updates to the Sunscreen Standard and Clarification and updates to the regulation of sunscreens.

If you are a sponsor of listed sunscreens, you should: 

• Review your sunscreens directions for use to ensure that these facilitate the application of the product so that consumers can obtain the claimed SPF. Please note that all listed medicines labels, including sunscreens, must display directions for use according to the meaning provided in section 3 of the Therapeutic Goods Act 1989. Please also note that it is a requirement of the sunscreen standard currently adopted by the TGA at the time of publication (AS/NZS 2604:2012), that sunscreen containers carry clear and adequate directions for use. 
• Ensure that you hold suitable evidence to support the dosage form of your sunscreen and its ability to deliver the claimed SPF. 
• Be aware that the TGA will adopt the 2021 Sunscreen Standard in July 2024. This standard specifies testing and labelling requirements for sunscreens, including aerosols, and could impact sunscreens under your sponsorship. 
• Ensure that the advertising of your sunscreen meets the requirements of the Therapeutic Goods Advertising Code, ensuring that it does not contradict relevant public health campaigns. 
• Be aware that repeatedly failing to comply with legislative requirements could result in higher-level enforcement actions, including financial penalties.

Related links

Updates to the Sunscreen Standard 

Safe use of sunscreens

Cancellations and suspensions

Cancellations

Product recalls

Recall actions database

Overview of the regulation of listed medicines and registered complementary medicines

Listed medicine compliance reports

Everything you ever wanted to know about sunscreens (but were afraid to ask)

Bondi Sands Everyday Protection Face SPF 50+ Sunscreen Mist – updated Directions for Use