Health Canada issued updated versions of both its Primary Sunscreen Monograph and Secondary Sunscreen Monograph on December 19, 2025, replacing the versions that had been in place since December 2018. For companies seeking market authorisation for sunscreen products in Canada, these are the documents that set out what is and is not permissible, from permitted medicinal ingredients and concentrations to labelling requirements and acceptable claims.
Understanding the current sunscreen monograph in Canada is a prerequisite for any compliant product submission. A further revision to the Secondary Monograph followed on February 27, 2026, introducing an additional language change with meaningful formulation implications.
Together, the two rounds of updates represent the most significant refresh of Health Canada’s sunscreen regulatory framework in nearly seven years. Keep reading to learn more and prepare for the updates.
What the Monographs Cover and Why They Matter
Sunscreens sold in Canada are regulated as either non-prescription drugs or natural health products (NHPs), depending on their active ingredients. Products containing mineral UV filters only – titanium dioxide and zinc oxide – are classified as NHPs and require a Natural Product Number (NPN).
Products containing chemical UV filters, such as avobenzone or octinoxate, are regulated as non-prescription drugs and require a Drug Identification Number (DIN). Both pathways are governed by the Natural and Non-prescription Health Products Directorate (NNHPD).
The monographs exist to streamline this authorisation process. A product that meets all the criteria set out in the applicable monograph can receive market authorisation without submitting additional evidence of safety or efficacy. Products that fall outside the monograph parameters must apply through a separate, more resource-intensive review stream.
Primary Monograph: Replacing the 2018 Version
The updated Primary Sunscreen Monograph applies to products where sun protection is the principal function – standalone sunscreens, sport formulas, and similar products. The December 2025 version replaces the December 7, 2018 edition and incorporates updated reference standards, including alignment with ISO test methods published in 2024 and the U.S. FDA’s current over-the-counter sunscreen monograph (M020, 2021).
Permitted medicinal ingredients, concentrations, and conditions of use have been reviewed against current scientific literature and international regulatory precedent. The document continues to distinguish between Table 1 NHP ingredients and Table 2 drug ingredients, with classification and submission pathway determined by which table a product’s active ingredients fall under.
Nano forms of titanium dioxide and zinc oxide remain permitted under specific conditions, with combined-use limits maintaining the same percentage caps. Labelling requirements are also addressed in detail. The mandatory warning statement for all primary sunscreen products remains unchanged, and the monograph reaffirms that SPF 50+ is the only acceptable “plus” indicator – all other SPF values must appear without a plus sign.
Secondary Monograph: A More Substantive Revision
The Secondary Sunscreen Monograph covers products where sun protection is a secondary function – foundations, tinted moisturisers, lip products, and similar cosmetic-adjacent formats. This category sees a more consequential set of changes.
The December 2025 update added Bemotrizinol (also marketed as PARSOL Shield) to the list of permitted medicinal ingredients in the Secondary Monograph, at a maximum concentration of 6%. Previously, Bemotrizinol was only approved for use under the Primary Sunscreen Monograph. The addition opens the ingredient to a wider class of formulations in the Canadian market, particularly multifunctional skincare and cosmetic products carrying limited SPF claims.
The February 27, 2026 revision went a step further. It removed a footnote previously attached to Table 2 that had constrained certain formulation parameters. That change has direct implications for formulation flexibility, giving manufacturers broader latitude in how they design secondary sunscreen products within the monograph stream.
Both updates together signal that the Secondary Monograph is evolving to better reflect modern product formats and international ingredient approvals. The Bemotrizinol decision also tracks with parallel regulatory activity in the United States, where the FDA is evaluating the ingredient for potential inclusion in its own OTC sunscreen monograph.
What This Means for Your Business
For companies with existing product licences, the monograph updates do not automatically trigger relabelling or resubmission requirements. Licences issued under the previous monographs remain valid. However, companies planning new submissions, or reformulations that bring a product back into the licensing process, should be working against the December 2025 editions, not the 2018 documents.
For companies formulating with Bemotrizinol, the secondary monograph pathway is now available where it was not before. That may reduce the regulatory burden for cosmetic-adjacent products that incorporate this filter, since qualifying products can now proceed via monograph rather than through a full evidence-based review.
The formulation flexibility introduced by the February 2026 Table 2 footnote removal is likely to be most relevant to brands developing multifunctional products with sun protection as a secondary function. Product teams working on new SKUs in this space should review the current secondary monograph closely to understand what the updated parameters permit.
Companies entering the Canadian market for the first time should also note that mineral-based sunscreens follow Canada’s NHP licensing process, while chemical-filter formulations follow the drug submission pathway. Confirming the correct classification before submission avoids delays that are difficult to recover from once the review clock has started.
Key Takeaways
- Health Canada released updated Primary and Secondary Sunscreen Monographs on December 19, 2025, replacing the 2018 editions.
- The Primary Monograph incorporates updated ISO test methods and revised alignment with the FDA’s 2021 OTC monograph.
- The Secondary Monograph now includes Bemotrizinol (PARSOL Shield) as a permitted ingredient at up to 6%, previously only approved under the Primary Monograph.
- A February 27, 2026 revision to the Secondary Monograph removed a Table 2 footnote, expanding formulation flexibility for secondary sunscreen products.
- Existing licences remain valid; the updated monographs apply to new submissions and reformulations entering the authorisation process.
Frequently Asked Questions
Do the December 2025 monograph updates affect my existing Health Canada product licence?
Existing product licences issued under the previous 2018 monographs are not automatically invalidated by these updates. Health Canada does not require licence holders to refile solely because a monograph has been revised.
However, any material change to a licensed product, including reformulation, may trigger a submission requirement, and that submission would need to meet the current monograph criteria. Companies should document their compliance position against the 2025 editions as part of routine licence maintenance.
My product contains Bemotrizinol. Does the Secondary Monograph update change my regulatory pathway?
It may, depending on your product format. Bemotrizinol was already a permitted ingredient under the Primary Sunscreen Monograph. The December 2025 Secondary Monograph update permits its use at up to 6% in products where sun protection is a secondary function, such as foundations, tinted moisturisers, or other cosmetic-adjacent formats with limited SPF claims.
If your product previously fell outside the secondary monograph stream because of this ingredient, the updated document is worth reviewing to determine whether your formulation now qualifies for the streamlined authorisation pathway.
What does the February 2026 footnote removal from Table 2 of the Secondary Monograph actually change?
The removed footnote previously placed restrictions on certain formulation parameters linked to Table 2 ingredients in secondary sunscreen products. Removing it gives formulators more flexibility in how they structure product compositions under the secondary monograph, without having to seek authorisation outside the monograph stream.
For brands working in multifunctional or cosmetic-hybrid categories, this is a practical formulation change rather than a classification change. The updated Secondary Sunscreen Monograph text, dated December 19, 2025 and revised February 27, 2026, is the authoritative reference for what is now permitted.
Next Steps for Sunscreen Compliance in Canada
Companies affected by the sunscreen regulatory updates in Canada should review both the updated Primary and Secondary Monographs against their current product portfolio and pipeline.
Whether you are preparing a first-time submission, managing existing licences, or assessing a new formulation against the monograph criteria, working from the correct version of each document is the starting point for a compliant process.
To discuss how these changes apply to your specific products, contact Quality Smart Solutions or learn more about our NHP licensing services for Canada.
