Be sun smart. Wear sunscreen.

This TGA behind-the-news article was published on 3 December 2018. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

With summer officially on our doorstep, the Therapeutic Goods Administration (TGA) is reminding Australians that sunscreens on the Australian market are safe and effective. Before you head out in the sun this summer, here is a quick summary of how the TGA regulates sunscreens and how you can use sunscreen effectively.

The TGA regulates sunscreens in Australia

The TGA regulates therapeutic goods in Australia. Most sunscreens as well as some insect repellents and moisturisers are considered to be therapeutic goods because they are intended to provide a certain level of sun protection.

Before a sunscreen can be legally supplied as a therapeutic good in Australia, it must be listed on the Australian Register of Therapeutic Goods (ARTG). You can tell that a sunscreen is listed on the ARTG because it will have an AUST L number on its label. You can also search the ARTG to find out if a particular sunscreen is listed.

Before a company can list a sunscreen on the ARTG and supply it in Australia, they must certify to the TGA that their product:

• includes only pre-approved ingredients that the TGA has assessed for safety
• meets the Australian standard for sunscreens
• meets standards for manufacturing quality
• meets testing requirements for sun protection performance
• meets other requirements related to labelling and advertising.

Our reviews find sunscreens to be safe and effective

The TGA conducts targeted and random reviews of sunscreens on the Australian market. The results of our reviews should give Australians confidence in the safety and quality of sunscreens sold in Australia.

We published the results of our latest review on 30 July 2018. This review examined the labels, documentation and evidence associated with 94 sunscreens. There were minor forms of non-compliance in about two thirds of the sunscreens. For example, some sunscreens did not fully comply with our labelling requirements. However, these forms of non-compliance were unlikely to cause harm to sunscreen users or significantly impact the effectiveness of the sunscreens in everyday use.

In 2017, we conducted laboratory testing of 31 commonly used sunscreens. All of the products tested contained the correct levels of active ingredients as specified on the label.

Nanoparticles in sunscreen do not pose a health threat

Some sunscreens contain nanoparticles to prevent sunscreen forming a visible layer on the skin. A nanoparticle is a tiny particle ranging from 1 to 100 nanometres in size (a nanometre is one billionth of a metre).

The nanoparticles in sunscreens do not pose a threat to your health. In 2017, we published our latest review of the scientific evidence related to titanium oxide and zinc oxide nanoparticles in sunscreens. The evidence suggests that these nanoparticles are highly unlikely to cause harm because they remain on the surface of the skin, which is made-up of dead skin cells.

New research supports the conclusion of our review. In a 2018 study by the University of South Australia, researchers asked five volunteers to apply sunscreen over five consecutive days. The researchers found that nanoparticles remained on the surface of volunteers’ skin and did not cause any damage to their skin cells.

Apply sunscreen liberally

Research shows that sunscreens are effective when applied frequently and liberally. This means at least a teaspoon for each limb, front and back of the body and half a teaspoon for the face, neck and ears every two hours. You should apply one cupped adult hand (30 to 40 ml) of sunscreen for an adult body.

When using an aerosol can, remember that some of the sunscreen may not land on your skin. It is recommended that you use approximately one third of an aerosol can on an adult body for adequate protection.

Apply sunscreen at least 20 minutes before going out into the sun and reapply your sunscreen more frequently if you have been swimming or sweating.

Be sun smart by using physical barriers as well

It is important to remember that sunscreen should not be your only protection from the sun. Other ways of being sun smart include limiting your exposure to direct sun, seeking out shade, and wearing a hat, sunglasses and appropriate clothing.

The Cancer Council and Australasian College of Dermatologists recommend minimising the use of sunscreen on babies less than 6 months of age (pdf,396kb) by using only on small portions of the body that can’t be covered by clothing and shade. A baby’s skin is sensitive, so spot tests are always recommended to check for any issues, including allergic reactions to ingredients such as fragrances and preservatives.

More information

• Sunscreens: information for consumers
• 2018 review of listed sunscreen products
• 2017 laboratory testing of sunscreen products
• Cancer Council: Sun Safety information
• Cancer Council Australia: Sunscreen and babies position statement