Health Canada Proposes Significant Changes to the Sunscreen Monograph

Health Canada has proposed changes to the current sunscreen monograph. The intention here is to align all changes with the requirements set forth in the United States Food and Drug Administration Sunscreen Drug Products for Over-the-Counter Human Use: Final Rule (2011).

Below we have compiled a summary, which includes, but is not limited to the following proposed changes to the draft sunscreen monograph:

UVA/UVB Claims – All broad spectrum sunscreens are to contain both UVA and UVB absorbers with a critical wavelength protection of at least 370nm.

Label Claim of UVA:UVB Ratio – Product may provide a UVA:UVB ratio labeling claim of not less than 1:3. The monograph will outline a specific test method.

NHP Medicinal Ingredients – In addition to the already approved use of Titanium dioxide and Zinc oxide in sunscreens, para-aminobenzoic acid ≤ 15% is proposed to be added to this list.

Drug Medicinal Ingredients – Concentrations of Avobenzone, Ensulizole, Octinoxate, Octisalate, Octocrylene, and Sulisobenzone have all been adjusted for the draft monograph. While most of these ingredients have decreased in concentration, Sulisobenzone is the only one that has increased its concentration allowance.

Nano Ingredients – Nano Titanium dioxide and Zinc oxide will now be considered allowable ingredients providing that the license holder continually monitors for new safety data as it becomes available.

SPF Over 50 – SPF values greater than 50 will be declared as ‘SPF 50+’

Skin Cancer Alert Statement – Sunscreens without broad spectrum protection or sunscreens with SPF value of <15 must use the following statement verbatim: “Skin Cancer/ Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Optional Claims – The following claims are acceptable as long as scientific product-specific data is available to support the claims:

1. Hypoallergenic

2. For sensitive skin

3. Non-comedogenic (won’t block pores)

4. Paediatrician tested/recommended, dermatologist tested/recommended; Water resistant/ Sweat resistant.

Logos from the CDA – This logo can be used provided that the application for a DIN or NPN is accompanied by a letter from the CDA accepting this representation.

FPR consultants strive to stay abreast Health Canada updates and regulation changes. For a more a comprehensive guide to the draft sunscreen monograph, contact a FPR consultant to assist you with your drug, cosmetic, medical device, and natural health product inquiries.