Health Canada recently announced the release of the final Sunburn Protectants Monograph, dated July 7, 2013 Version 2.0. The document is titled “Sunscreen Monograph” to reflect the common term used by Canadian’s to describe this category of products. This monograph replaces the existing Sunburn Protectants Monograph of October 12, 2006. It identifies permitted medicinal/non-medicinal ingredients, concentrations, indications, directions and conditions of use for these products to be licensed without the submission to Health Canada of additional evidence. It also contains the test methods recommended to be used to comply with the requirements of this monograph. The final monograph is the result of a thorough survey of existing regulations, guidance documents, policies and current practices within Health Canada and other leading regulatory agencies.
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