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Sunscreens: information for consumers

18 December 2019

Applying sunscreen is just one way to protect yourself from the sun and reduce your risk of skin cancer. Sunscreen products can come in a range of forms, with the most popular being lotions and aerosol sprays. It is important you understand how to choose the right product for your skin and how to apply it correctly so that it is effective.

Sunscreens regulated by the TGA

The TGA regulates therapeutic sunscreens. These include:

  • primary sunscreens - sunscreens used for protection from UV radiation that have a rated sun protection factor (SPF) of 4 or more
  • secondary sunscreens - insect repellents with sunscreen with an SPF of 4 or more and moisturisers with sunscreen with an SPF greater than 15.

They are distinguishable from cosmetic sunscreens because they have an AUST L number on the label, meaning they are 'listed' on the Australian Register of Therapeutic Goods (ARTG).

All sunscreens regulated by us are entered in the ARTG.

Which sunscreen to use and how to apply correctly

The SPF indicates how effective the sunscreen is against sunburn. The term 'broad spectrum' means that the sunscreen protects your skin from both UVB and UVA radiation. UVA is the radiation that is believed to be the main cause of long-term damage. Sunscreens that are not broad spectrum only protect against UVB radiation.

You should choose a product appropriate to your skin sensitivity and exposure to the sun. For example, if you have fair skin and burn easily, a broad spectrum sunscreen with an SPF of 30 or 50+ may be most appropriate for you.

If you are sweating heavily or swimming, a water-resistant sunscreen should be used. Only products with an SPF of 30 or more can claim a 4-hour water-resistant period.

Regardless of the type of sunscreen you choose, you should apply liberally every two hours - at least a teaspoon for each limb, front and back of the body and half a teaspoon for the face, neck and ears. You should apply one cupped adult hand (30 to 40 ml) of sunscreen for an adult body.

All sunscreens regulated by us provide appropriate protection as long as they are applied regularly and the instructions on their labels are followed. The Cancer Council website has more useful information on how to be SunSmart.

Remember - clothing, hats, sunglasses, keeping to the shade as much as possible and avoiding excessive exposure of the skin to the sun's radiation need to be combined with the liberal application of any sunscreen. You also need to reapply sunscreen often in order to maintain your protection.

How the TGA regulates sunscreens

The TGA assesses the safety of ingredients used in sunscreen products, and not the product itself, before a product is released onto the market.

All therapeutic sunscreens must meet mandatory requirements for:

  • labelling
  • advertising
  • testing
  • ingredients.

Sunscreens must be manufactured by a TGA approved manufacturing facility, and can only include TGA approved ingredients - each of which has been assessed for safety.

Sunscreens must also meet the requirements set out in the Australian/New Zealand Standard AS/NZS 2604:2012 Sunscreen products - Evaluation and classification.

This standard was developed by Standards Australia, not by the TGA, and can be accessed via the Standards Australia website.

Testing SPF, broad spectrum and water resistance claims

As these tests require specialised instruments, facilities, human volunteers and scientific/statistical expertise, the TGA does not undertake these tests. Instead they are run by other laboratories.

For example, SPF testing is highly specialised and requires human subjects, so it is often performed by independent accredited laboratories. However, as part of our post-market compliance program, we may also undertake random reviews of some sunscreens once they are on the market and will undertake a desktop assessment of the SPF testing data.

Monitoring sunscreens once they are on the market

People who use sunscreens are encouraged to report any side effects or problems they experience with any therapeutic goods, including sunscreens. We use these reports to monitor any possible issues with products on the market.

If complaints arise about a particular sunscreen, we may test these in our laboratories. TGA laboratories are approved to check the level of active ingredients and microbiological quality using samples from retail outlets.

Over 300 sunscreen products have been tested in the TGA Laboratories since 2005. This has included sprays, gels, lotions, foams and roll-ons for babies, children and adults.

In 2017, the level of active ingredients was tested in 31 sunscreens including lotions, creams and aerosol sprays. All products were found to contain the correct levels of organic UV-blocking ingredients. The content of inorganic UV blockers, such as zinc oxide and titanium dioxide, was not measured. Since 2009, testing by the TGA has shown a significant improvement in compliance of sunscreen samples with respect to labelling and formulation requirements.

Sunscreens may also be randomly reviewed as part of our post-market compliance program for listed medicines to make sure they comply with relevant regulatory requirements that support the safety, quality and efficacy of the products.

FAQs

Understanding a sunscreen label

The main label on sunscreen containers or cartons contain the following information:

  • the product name
  • the sun protection factor (SPF)
  • the water resistance of the product (if relevant and in hours and/or minutes)
  • the statement 'broad spectrum', if relevant.

Some labels may contain the protection category 'low', 'medium' or 'moderate', 'high', or 'very high'.

You will also find information on:

  • the dose form (cream, lotion or spray)
  • the net quantity of goods
  • Australian Register of Therapeutic Goods listing numbers (for example, AUST L 12345)
  • active ingredients
  • an expiry date
  • a batch number.

The plus sign means that the SPF rating is higher than the number. For example, a sunscreen with an SPF of 50+ must have an SPF of 60 or more.

SPF50+ sunscreens offer the same level of UVB protection as an SPF30 sunscreens, but offer extra UVA protection. SPF50+ sunscreens allow 1/50th of ambient UV radiation through, but filter out 98% of UVB radiation. SPF30 sunscreens admit 1/30th of ambient UV radiation, but block out 96.7% UVB.

Testing requirements for sunscreens

Sunscreens regulated by us fall under the 'Listed medicines' framework. Listed medicines are considered lower risk, and are subject to less stringent rules than other products such as prescription medicines. As with all listed medicines, the TGA evaluates the safety of the ingredients used in sunscreen products before they are made available, but does not test the complete sunscreen product as a whole. There is a pre-determined list of ingredients that can be used, and a sunscreen containing only these ingredients can be listed for sale in Australia without further oversight by the TGA.

Therapeutic sunscreens must comply with the most current Australian and New Zealand Sunscreen Standard (the Sunscreen Standard), which includes tests to determine broad spectrum, SPF and water resistance according to international ISO standards.

Cosmetics sunscreens are not regulated by the TGA. Products that are considered to be cosmetic sunscreens include:

  • products applied to the lips that contain sunscreen and have an SPF of 4 or greater
  • tinted bases and foundations that contain sunscreen and have an SPF of 4 or greater
  • moisturising skin care products that contain sunscreen and have an SPF 15 or less, and are in a pack size no larger than 300 ml or 300 g
  • sunbathing skin care products that contain sunscreen and have an SPF between 4 and 15, and are in a pack size no larger than 300 ml or 300 g.

The manufacture and importation of cosmetic ingredients are regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).

The product safety and cosmetic labelling standards are the responsibility of the Australian Competition and Consumer Commission (ACCC).

Water resistance is measured by determining the SPF measurement after the period of water immersion claimed on the product. For example, a product with 2 hours water resistance was tested for its SPF after the product was applied to the skin and immersed in water for 2 hours.

The SPF is measured on human skin in a laboratory by determining how much time it takes for intense ultraviolet radiation (specifically UVB) to burn skin that has been liberally applied with sunscreen compared to skin that has no application of sunscreen. For example, if skin protected with sunscreen takes 300 seconds to burn during the test, but only 10 seconds to burn without sunscreen, the SPF is 300/10, which is 30.

Ingredients in sunscreens

A nanoparticle is a particle within the nanoscale range of 1 to 100 nanometres in size. A nanometre is one millionth of a millimetre. These are invisible to the human eye.

Humans are exposed to nanoscale particles in the environment in the form of smoke, dust, ash and fine clays through the air, food and water. Foods are also naturally composed of nanoscale components.

Nanoparticles are used in a variety of therapeutic products including some sunscreens.

Zinc oxide and titanium dioxide were the first ingredients to be used in Australian sunscreens in nanoparticle form; however, other ingredients may be used in nanoparticle form if this has been specifically evaluated and approved by the TGA.

In Australia, all active ingredients, including those in nanoparticle form, must be declared on sunscreen labels to help consumers make informed choices. However, it is not currently a requirement for sunscreen labels to declare the particle size of the active ingredients. This is because there is no evidence suggesting that nanoparticles in sunscreen are unsafe. Sunscreens deemed to be unsafe based on safety assessments, with or without nanoparticles, will not be approved and cannot be legally sold in Australia.

No.

Nanoparticles have been present in some sunscreens since at least 1990.

To date, evidence shows that the particles remain on the surface of the skin, which is composed of non-viable (dead) cells, and therefore pose no threat to human health.

Any application to register a new sunscreen ingredient must undergo a safety assessment, and all products are subject to post-market monitoring. This means that the TGA must be satisfied that the benefits of a product outweigh the risks before it can be sold legally in Australia, and will continue to monitor the product for as long as it is on the Australian Register of Therapeutic Goods (ARTG).

The TGA actively monitors local and international research on nanoparticles in sunscreens. A Literature review by the TGA on the safety of titanium dioxide and zinc oxide nanoparticles in sunscreens was first published in 2006, and is regularly updated. Nanoparticles are also found in some foods and cosmetics, and their safety is assessed by Food Standards Australia and New Zealand (FSANZ) and the National Industrial Chemicals Notification and Assessment Scheme (NICNAS).

Further information