As labelling requirements for sunscreen products are tightened in the US and other countries, companies are finding ways to enhance the UV filter effects of their sunscreen ingredients. John Woodruff reports
In December 2012 the final rule on sunscreens in the US went into effect, requiring that sunscreen products introduced in the US on or after 17 December 2012 comply with its testing and labelling requirements. One of the significant changes is that the SPF must be above 15 in order to make the claim that “sunscreen reduces the risk of skin cancer and early skin ageing when used as directed”. The Food and Drug Administration (FDA) also proposes to limit the maximum SPF on sunscreen labels to 50+ as it believes that there is insufficient data to show products with SPF values higher than 50 provide greater protection for users than products with an SPF of 50.
Other changes introduced by the regulation include the banning of common phrases such as ‘sunblock’, ‘waterproof’, ‘prevents skin cancer’, etc and specific testing must be completed for each sunscreen product before other claims about the product’s UVA and UVB protection can be made. These and other requirements are published in Final Monograph 21 CFR, part 352: Sunscreen Drug Products for Over-the-Counter Human Use.
Canada has its own rules and in November 2012 Health Canada announced the release of the revised Guidance Document Sunscreen Monograph, which states that all broad spectrum sunscreen products are required to contain both a recognised UVA and a UVB absorber, to be minimum SPF15 and to have a critical wavelength protection of at least 370nm. In addition, the UVA:UVB ratio must not be less than 1:3. The monograph lists all the UV absorbers permitted for use in Canada and allows nano-sized titanium dioxide and zinc oxide to a maximum of 25% by weight, based on the total weight of the composition.[1]
Australia has also been updating its regulations. In November 2012 it introduced a change that allows the labelling of sunscreen products with a rating of up to SPF50+, which replaces the previous maximum of SPF30. According to the Department of Health and Ageing’s Therapeutic Goods Administration (TGA), SPF50+ sunscreens provide better protection from sunburn and long term skin damage. It says an SPF50+ sunscreen allows much less UVA radiation, which is largely responsible for melanomas and skin cancer, to pass through a layer of sunscreen.[2]
Sunscreens fall into two different categories in Australia. Therapeutic sunscreens are intended primarily for protection of the skin from the sun’s UV radiation and are regulated by the TGA. Cosmetic sunscreens such as moisturisers with SPF15 or less, sunbathing products with less than SPF15 and make-up products of any SPF are regulated by NICNAS (also part of the Department of Health and Ageing) and the Australian Competition and Consumer Commission (ACCC).