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January 11, 2013

Canada Begins Public Consultation on Revised Draft Guidance Document Sunscreen Monograph

Lynn L. Bergeson

On November 21, 2012, Health Canada began a public consultation on a Draft: Guidance Document — Sunscreen Monograph, which is intended to replace the existing 2006 Sunburn Protectants Monograph. The draft Monograph identifies the permitted ingredients, including nano zinc oxide and nano titanium dioxide; doses; directions and indications for use for these products, which will be required to appear on the product labels; and the recommended supporting test methods. The draft Monograph notes that license holders are expected to continue monitoring and collecting new safety data as they emerge. Applicants are required to keep information for recordkeeping purposes when nano zinc oxide and/or nano titanium dioxide are used in sunscreen products, and this information is required to be made available upon request. Comments are due February 19, 2013.