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Sunscreens: information for consumers

29 January 2014

We regulate:

  • 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 and an SPF greater than 15.

These products are referred to as therapeutic sunscreens and are distinguishable from cosmetic sunscreens because they have an AUST L number on the label.

All sunscreens regulated by us are entered in the Australian Register of Therapeutic Goods (ARTG) and you can search for them on the TGA website.

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SPF ratings

What does SPF mean?

The SPF (sun protection factor) of a sunscreen is a measure of how well it protects the skin from sunburn.

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.

Sunscreen is applied liberally in the SPF test. The product will only deliver the level of protection claimed on the label if it is applied liberally.

What does broad spectrum mean?

Sunscreens that are labelled as being 'broad spectrum' provide protection from UVA radiation from the sun, as well as UVB.

Tell me more about UVA and UVB?

The portion of the sun's UV spectrum with wavelengths in the range 290 to 320 nanometres is known as 'UVB' and is mainly responsible for sunburn.

The portion of the sun's UV spectrum with wavelengths in the range 320 to 400 nanometres is known as 'UVA'. This penetrates deeper into the skin than UVB radiation and is considered to be mainly responsible for the longer term damage resulting in melanomas and other skin cancers.

What does the plus (+) sign mean?

The plus sign means that the SPF is higher than the number shown.

  • In the 2012 Australian standard for sunscreens, the plus sign for SPF50+ means that the SPF is significantly higher than 50. To qualify for a 50+ rating the test result must be 60 or higher.
  • In the 1998 standard the plus sign for SPF30+ means that the SPF is simply higher than 30. To qualify for a 30+ rating the test result must be 31 or higher.
What does 'very high protection' mean?

The criteria for categorising protection have changed, so that for new products, only SPF 50+ can be classified as very high protection.

Protection Category 1998 Standard 2012 Standard
Low SPF 4 - 7 SPF 4, 6, 8, 10
Moderate (or medium) SPF 8 - 14 SPF 15, 20, 25
High SPF 15 - 29 SPF 30, 40, 50
Very high SPF 30 or 30+ SPF 50+
What does 'water resistant' mean? Does this change on new sunscreens?

Many sunscreens are designed to be used while swimming, surfing or participating in other water sports.

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.

Water resistant products still need to be reapplied regularly due to being worn or rubbed off, e.g. during towelling dry.

The criterion for the 'water resistant' claim is essentially unchanged for SPF 50+ products. The maximum water resistant claim period of 4 hours is only allowed for products which have SPFs of 30 or more after immersion in water.

Guidance on using sunscreens

How should I apply sunscreen?

Apply sunscreen 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.

How do I know which sunscreen to use and when?

The SPF informs consumers of the effectiveness of the sunscreen against sunburn and helps them select a product appropriate to their skin sensitivity and exposure to the sun.

If you are sweating heavily or swimming, water resistant sunscreen should be used.

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 has lots of information on how to be SunSmart.

What about cosmetics and moisturisers containing sunscreens?

Sunscreens can be either 'primary sunscreens' (intended primarily for protection of the skin from the sun's UV radiation) or 'secondary sunscreens' (intended primarily for a purpose other than sunscreening but also containing sunscreening agents).

In Australia, sunscreens fall into two categories for regulatory purposes, namely, 'therapeutic sunscreens' and 'cosmetic sunscreens', and are regulated by different government agencies as follows:

Therapeutic sunscreens Cosmetic sunscreens
Regulated by the TGA Regulated by National Industrial Chemicals Notification and Assessment Scheme (ingredients) and the Australian Competition and Consumer Commission (labelling)

Includes:

  • All 'Primary sunscreens'
  • 'Secondary sunscreens' that are not 'cosmetics' as described in Cosmetic Standard 2007 - mainly moisturisers containing sunscreen with an SPF greater than 15
  • all sunscreens (SPF 4 or more) that contain an insect repellent
  • sunscreens with ingredients that are from humans, or particular organs from:
    • cows
    • sheep
    • goats
    • mule deer.

Includes secondary sunscreens that are 'cosmetics' as described in the Cosmetic Standard 2007, namely:

  • Moisturisers with sunscreen if SPF is 15 or less (pack size no more than 300 mL)
  • Sunbathing products with SPF between 4 and 15 (pack size no more than 300 mL)
  • Lip balms/lip sticks with sunscreen (any SPF)
  • Make-up products with sunscreen (any SPF)

Check the ACCC and NICNAS websites for more information on cosmetic sunscreens.

Sunscreen regulation

What regulatory requirements apply to sunscreens?

All therapeutic sunscreens must meet mandatory requirements for:

  • labelling
  • advertising
  • testing
  • ingredient requirements.

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.

Further details can be found on our webpage How the TGA regulates sunscreens, and in the Australian regulatory guidelines for sunscreens.

What is the Australian standard for sunscreens?

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.

Nanoparticles in sunscreens

What is nanotechnology?

Nanotechnology is a set of technologies that enables the manipulation, study or exploitation of very small structures and systems1.

A nanoparticle is a particle within the nanoscale range of 1 to 100 nanometres in size; a nanometre is one millionth of a millimetre.

1OECD description of nanotechnology

What nanoparticles are used in sunscreens?

Nano-sized titanium dioxide particles have been used in sunscreens since at least 1990 and nano-sized zinc oxide particles have been used in sunscreens since 1999.

These two substances are particularly valuable in sunscreens because they give broad protection from damaging sunlight.

Are there risks associated with sunscreens containing nanoparticles?

The potential for nanoparticles in sunscreens to cause adverse effects depends on their ability to penetrate the outer layer of the skin to reach the viable (living) cells within the deeper skin layers.

To date, the evidence shows that the particles remain on the surface of the skin, which is composed of non-viable (dead) cells.

I read a news report in January 2014 that said nanoparticles in sunscreen are absorbed into the bloodstream and eliminated by the immune system. Why do you say that they only remain on the skin?

The news reports that you refer to misreported the outcomes of a study undertaken in Melbourne. This study exposed cell cultures of human macrophages, a type of cell in the human immune system, to zinc oxide nanoparticles to see how they would respond. The macrophages absorbed the particles and broke them down.

The study did not look at whether the particles are absorbed through the skin and into the bloodstream. The current available evidence indicates that this does not happen and the particles remain on the skin.

How do I know if my sunscreen contains nanoparticles?

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.

Titanium dioxide and zinc oxide are the only active ingredients allowed in sunscreens in Australia that can be nanoparticles.

Where do I find out more information?

We have conducted a review of the safety of zinc oxide and titanium dioxide nanoparticles used in sunscreens. The outcomes of the Literature review on the safety of titanium dioxide and zinc oxide nanoparticles in sunscreens is available on the TGA website.

About SPF 50+ sunscreens

What will SPF 50+ do to improve sun protection?

How well a sunscreen works is determined by testing for two properties:

  1. the 'sun protection factor' (SPF) - which measures the degree of protection against UVB radiation
  2. the 'broad spectrum performance' - which is a measure of the degree of protection from UVA radiation.

SPF 50+ sunscreens have an increased SPF factor and are required to meet more stringent broad spectrum requirements.

While SPF 50+ sunscreens provide better broad spectrum performance, this does not mean you have a 'suit of armour'; people still need to be SunSmart.

You need to apply SPF 50+ sunscreen just as liberally as SPF 30+. In addition, as with other sunscreens, SPF 50+ may rub off through towelling, swimming, and perspiration. The rule for applying SPF 50+ remains the same: apply liberally and re-apply liberally every 2 hours.

Will the SPF 50+ sunscreens mean that I can now stay in the sun as long as I like and be protected? Or do I still need to be SunSmart?

Sunscreen in isolation is not sufficient protection from the sun.

The introduction of higher SPF sunscreens does not affect the importance of being SunSmart. 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 sunscreen, whatever the SPF. You also need to reapply sunscreen often in order to maintain your protection.

What will be on the label with SPF 50+?

From 10 November 2012, the main labels 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'
    • both 30+ and 50+ are labelled as broad spectrum sunscreens. However, any new sunscreens listed from 10 November 2012 labelled as SPF 30 (rather than 30+), 40, 50, 50+ must comply with the new definition of broad spectrum.

Labels may also contain the protection category 'low', 'medium' or 'moderate', 'high', or 'very high'.

If you would like to purchase a sunscreen product containing a sun protection factor of 50 or higher, simply look for the number 50 next to SPF.

Labels will also contain 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.
Is SPF 50+ available in any other countries? Are these the same products that will be available in Australia?

Sunscreens with SPF of 50 or more are available in some other developed countries, including New Zealand, the US and many European countries. Some of these products may be imported and sold in Australia, but will need to comply with the 2012 Sunscreen Standard and other parts of Australian regulation. For example, the labelling may need to be different to meet Australian requirements.

About SPF 30+ sunscreens

Should I stop using SPF 30+?

No. Under the 1998 Standard, a 30+ rated sunscreen must have yielded an SPF test result of 31 or higher, which will still provide you with high protection from UV radiation.

Should I throw out my existing sunscreens?

No. The new standard does not mean other sunscreens don't work. They remain a valid and useful sun protection - as long as they have not passed their use by date or deteriorated due to other reasons.

Will I be able to continue buying SPF 30+ and other SPF rated sunscreen products?

Yes. All sunscreen products that complied with the previous standard and were listed on the ARTG before 10 November 2012, whatever the SPF, will still be allowed to be manufactured and sold in Australia until the supplier chooses to cease supply. Products which meet either of the standards will still afford you effective sun protection, and as outlined above, the SPF and protection category ratings will help guide you in choosing the right sunscreen product for your purpose and need.

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Content last updated: Wednesday, 29 January 2014

Content last reviewed: Wednesday, 29 January 2014

Web page last updated: Wednesday, 29 January 2014

URL: http://www.tga.gov.au/consumers/sunscreens-2012.htm