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Health Canada updates sunscreen monograph for the industry

By Michelle Yeomans , 23-Jan-2013
Last updated the 23-Jan-2013 at 17:40 GMT

The federal department responsible for assessing the safety of drugs and consumer products in Canada has revised its’ ‘Sunburn Protectants Monograph in a bid to provide up to date information for the industry on how to comply with governing statutes and regulations in the country.

The newly titled "Guidance Document Sunscreen Monograph" is intended to replace the existing monograph of 2006 and identifies ingredients, doses, directions and indications for use of sunscreens, which will be required to appear on the product labels as well as the recommended supporting test methods.

The requirements set forth align with the FDA’s Sunscreen Drug Products for Over-the-Counter Human Use: Final Rule (2011). As such, sunscreens meeting the Administration’s requirements are also meeting the ones outlined in this monograph.”

According to the federal body, the development of the monograph is the result of a survey of existing regulations, guidance documents, policies and current practices within Health Canada and other leading regulatory agencies.

Revised

Sunscreens may include products for use only as sunscreens and those which provide sun protection in addition to a cosmetic attribute that are intended to provide protection against sunburn and Ultraviolet (UV) rays. They are classified as drugs and must meet the requirements set out in Canada's Food and Drugs Act before they may be imported, advertised, or sold in the country.

The revised monograph outlines various areas for manufacturers looking to bring their product to the Canadian market to adhere to, such as the requirements necessary to receive marketing authorization like a Drug Identification Number (DIN) or a Natural Product Number (NPN).

It further identifies that sunscreens are either classified as natural health products if containing the ingredients Titanium dioxide (TiO2), Zinc oxide (ZnO) and Para-aminobenzoic acid, or classified as drugs if containing ingredients like Avobenzone, Ensulizole or Dioxybenzone for example.

The document also addresses what is acceptable and unacceptable in terms of labeling, including the proviso for sunscreens providing broad spectrum protection with a SPF value ≥ 15 having the ability to use the following statement: “The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects.”

On the other hand, the document rules as unacceptable are claims that are misleading or counter intuitive to the safety and efficacy of sunscreen use, including wording to the effect of “sunblock”, “sun shield”, or any other term implying that the product either prevents UV ray penetration and/or provides total or complete protection for example.

To get a full rundown of the revised document, please see here .

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