It seems almost impossible to get a moisturizer these days without it offering some kind of sun protection. Indeed even our shampoo and styling mists have got in on the act - you don't want your colour to fade and nobody likes straw hair! However, in the rush to UV protect everything it is worth looking at the legal ramifications of it all as this is one area where it pays if everyone to play safe.

STAKING YOUR CLAIM

1) SPF - anything being sold with an SPF higher than 3 would have been tested by a third party laboratory in accordance with the Australian Standard - AS/ NZS: 2604. It is important to remember that this is even required if the primary purpose of your product is for mositurisation or gloss (as in a lip gloss).

2) Other Sun Protection Claims - You need to be very careful when claiming that your product protects from UV rays as these are regulated under the TGA and must be substantiated. For example it would be fine to state that your formulation contains UV protective actives and that they help protect from the harmful effects of the suns rays but you couldn't say that your formulation 'gives broad-spectrum protection from UV rays". Further advice specific to your formulation is available via our team under a consultancy agreement if required.

3) Water Resistance - This is a TGA claim and therefore any mention of water-resistance must be substantiated.

4) Broad-Spectrum - Again you would need to prove this as this claim falls under clause 7.2 of AS/NZS 2604:1998. If your products primary function is as a sunscreen you can use the worlds 'broad spectrum' as long as you meet the criteria but when the sun protection is a secondary claim, say for in an anti-ageing product you would claim that 'helps to prevent premature skin ageing' if applicable. Broad spectrum means that a formula protects from UVA and UVB wavelengths and both are important in preventing skin damage from excessive sun exposure. This can be measured via a UVA ratio - you may find this site interesting: http://www.aptf.com.au/howsunscreenwork#spectrum

5) Moisturisation with anti-ageing benefits - This is where most products fall, they may have added some sunscreen actives into a moisturizing base as part of an anti-ageing strategy. These products do not claim to have an SPF and have not been tested. Additionally they should not imply any specific level of sun protection as SPF is about much more than just putting the ingredients in. These products are regulated as cosmetics.

FORMULATING

Before you get all excited about taking your whizz bang moisturizer to the next level it is worth remembering that UV filters are themselves regulated and the level that you can put into a formulation is capped. The rules surrounding what is allowed and what isn't vary throughout the world and are under constant review so it is worth doing your research before loading up on UV actives. Here are some common limits for the Australian market.

Ethylhexyl Methoxycinnamate - Up to 10%
Benzophenone-4 - 10%
Titanium Dioxide - 25%
Zinc Oxide - No Limit.

Once your formulation falls under a TGA category (anything over a claimed SPF of 4) all of your ingredients must be on the allowed list. It is possible to get new listings for things like actives, fragrances, emulsifiers and preservatives but there will most definitely be costs and time involved in order to collate all of the required safety evidence. Therefore if you wish to go down the TGA route it is better to have this in mind at the start of formulating.
It is also worth while pointing out that loading your formulation up with UV actives may not result in a higher SPF or protection. Therefore if you are not getting your formulation tested you would be wise to advise your customers not to rely on your product for sun protection. SPF figures can be lower than expected due to the product not giving good coverage, not sticking to the skin properly, not being dispersed thoroughly or being washed away by sweat. It is an area of development that can be very tricky!

MANUFACTURING

Therapeutic vs. Cosmetic - If your product will be sold with an SPF (even as a secondary feature) it needs to be manufactured in a TGA facility. If you are just adding sun protection to a moisturizer for anti-ageing claims you can manufacture under cosmetic conditions. Typically TGA facilities charge higher rates per unit of product than non TGA because of the greater complexity and regulations in that industry. In addition you may find that the minimum run size is larger than a non-TGA can offer. Do your homework early to avoid disappointment!

LABELLING

Depending on where your product fits you will come under either TGA or ACCC guidelines for labeling, it is important to understand where your product falls so that you can label correctly. As a guide, any product where the primary claim is sun protection will fall under TGA guidelines even when the SPF is low. SPF tested moisturizers (up to SPF 15) are cosmetics as long as they comply with the definition laid out in the cosmetic standard. http://www.nicnas.gov.au/
Cosmetics having a secondary SPF function can't claim water resistance, have an SPF greater than 15 or make any therapeutic claims relating to skin cancer. In addition, these products can't
be sold in packs exceeding 300ml. Stability wise should these products not reach a shelf-life of 36 months they are required to include an expiry or use-by date on the label.

ANY OTHER BUSINESS

As stated at the beginning of this article, UV filters are popping up in a variety of formulations and so it is worth having a quick look at some other applications.
Hair Care - UV filters can help to prevent hair dye fading over time but to do this they have to be able to stick to the hair and for this reason specialized filters have been developed to boost efficacy. However, you may find that you get an acceptable result in using one of our chemical filters in a leave-on styling product. Try Benzophenone 4 or Ethylhexyl methoxycinnamate.
Product protection - UV filters pop up in all kinds of places, even in body and room sprays and this is because they can aid in boosting your products shelf life and appearance. Products packed in clear bottles can fade over time and so a little beozophenone 4 or ethylhexyl methoxycinnamate is often added to boost the shelf life of colours. If this isn't suitable for your product, changing packaging to something UV protecting may be another alternative.
Lips - Many sunscreens now come with a little UV additive as this can help with preserving the colour and protecting the lips. All of the filters could work for this application depending on what else you have in your product.

A FINAL WORD

The inclusion of UV actives into your formulation may help with product positioning, claim substantiation, boosting shelf life, efficacy and of course, sun protection. However, as the above information shows you do need to tread carefully both in terms of your formulation and the claims that you make and it pays to remember that more filter doesn't always mean more coverage.

Have fun in the sun!

Amanda Foxon-Hill

29 Nov 2010