Canada Monograph Updates 2026: Primary & Secondary Sunscreens, Acne Products, and What Companies Need to Know
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In Canada, regulatory compliance for certain product categories that sit at the intersection of cosmetics and therapeutic products, such as sunscreens and acne treatments, relies heavily on monographs issued by Health Canada.
These documents define pre-approved conditions under which products may be authorized without submitting a full safety and efficacy dossier. Recently, several monographs have been updated, notably those covering primary sunscreens, secondary sunscreens, and acne therapy products.
These updates raise important questions for companies developing, maintaining, or importing products on the Canadian market in 2026. This article provides a practical overview of the changes and outlines what companies should review to ensure continued compliance.
What are monographs and why do they matter in Canada?
Monographs are regulatory documents published by Health Canada that specify:
- which active ingredients are permitted,
- acceptable concentration limits,
- formulation conditions,
- labeling and claims requirements,
- performance and testing criteria.
When a product fully complies with an applicable monograph, it may follow a simplified authorization pathway, such as a Natural Product Number (NPN) or Drug Identification Number (DIN), depending on how the product is classified.
For companies, monographs provide regulatory clarity and predictability, but only when products strictly meet all specified conditions. Any deviation may require a different regulatory pathway or additional data.
Primary vs. secondary sunscreen monographs: understanding the distinction
Canada differentiates between primary and secondary sunscreen products, based on their intended function.
Primary Sunscreen Monograph
The Primary Sunscreen Monograph applies to products whose main intended purpose is sun protection. It establishes detailed requirements covering:
- approved UV filters,
- maximum concentrations,
- SPF testing and performance standards,
- mandatory warnings and directions for use.
Products falling under this monograph are typically regulated as natural health products or drugs, rather than cosmetics.
Secondary Sunscreen Monograph
The Secondary Sunscreen Monograph applies to products where sun protection is not the primary function, such as moisturizers or skincare products that include SPF as a secondary benefit.
This pathway imposes stricter limitations on:
- the claims that can be made,
- how SPF is presented,
- labeling and consumer communication.
Correctly determining whether a product qualifies as primary or secondary is critical. Misclassification can result in authorization delays or non-compliance findings.
Recent updates to sunscreen monographs
Recent updates to the sunscreen monographs aim to clarify regulatory expectations and reflect current scientific assessments. While the overall structure of the monographs remains familiar, companies should pay close attention to:
- ingredient eligibility and concentration limits,
- SPF testing documentation,
- updated wording for claims and directions for use.
Products already on the market may require reassessment to confirm continued alignment with the revised monograph criteria.
Updates to the acne therapy monograph
Canada also maintains a dedicated monograph for acne therapy products, covering active ingredients such as benzoyl peroxide and salicylic acid.
Recent updates reinforce:
- concentration thresholds,
- permitted indications,
- required warnings and usage instructions.
These products frequently sit at the boundary between cosmetic and therapeutic categories, making careful classification and claims review particularly important.
Practical implications for companies in 2026
The recent monograph updates do not automatically impose new obligations on all products. However, they do require companies to:
- confirm which monograph applies to each product,
- reassess formulations against updated conditions,
- review labeling and claims language,
- ensure authorization dossiers remain accurate and complete.
Products that no longer fully comply with monograph requirements may need reformulation or a reassessment of their regulatory pathway.
Monographs and multi-market strategies
Canadian monograph requirements often differ from regulatory frameworks in the United States or Europe. A product compliant under a Canadian monograph may still require formulation or claims adjustments for other markets.
Maintaining structured, market-specific regulatory data is essential to manage these differences efficiently and avoid delays in product launches.
Conclusion
The recent updates to Canadian monographs for sunscreens and acne products reflect Health Canada’s ongoing efforts to clarify expectations and align authorization pathways with current scientific standards.
For companies, 2026 should be treated as a review and consolidation year, ensuring that existing and future products remain fully aligned with applicable monographs and regulatory requirements.
Going further
If you have questions about how these monograph updates apply to your products or portfolio, our regulatory team can support you.
You can also subscribe to our cosmetics regulatory newsletter to receive early updates on regulatory developments in Canada, the U.S., and Europe.
In Canada, regulatory compliance for certain product categories that sit at the intersection of cosmetics and therapeutic products, such as sunscreens and acne treatments, relies heavily on monographs issued by Health Canada.
These documents define pre-approved conditions under which products may be authorized without submitting a full safety and efficacy dossier. Recently, several monographs have been updated, notably those covering primary sunscreens, secondary sunscreens, and acne therapy products.
These updates raise important questions for companies developing, maintaining, or importing products on the Canadian market in 2026. This article provides a practical overview of the changes and outlines what companies should review to ensure continued compliance.
What are monographs and why do they matter in Canada?
Monographs are regulatory documents published by Health Canada that specify:
- which active ingredients are permitted,
- acceptable concentration limits,
- formulation conditions,
- labeling and claims requirements,
- performance and testing criteria.
When a product fully complies with an applicable monograph, it may follow a simplified authorization pathway, such as a Natural Product Number (NPN) or Drug Identification Number (DIN), depending on how the product is classified.
For companies, monographs provide regulatory clarity and predictability, but only when products strictly meet all specified conditions. Any deviation may require a different regulatory pathway or additional data.
Primary vs. secondary sunscreen monographs: understanding the distinction
Canada differentiates between primary and secondary sunscreen products, based on their intended function.
Primary Sunscreen Monograph
The Primary Sunscreen Monograph applies to products whose main intended purpose is sun protection. It establishes detailed requirements covering:
- approved UV filters,
- maximum concentrations,
- SPF testing and performance standards,
- mandatory warnings and directions for use.
Products falling under this monograph are typically regulated as natural health products or drugs, rather than cosmetics.
Secondary Sunscreen Monograph
The Secondary Sunscreen Monograph applies to products where sun protection is not the primary function, such as moisturizers or skincare products that include SPF as a secondary benefit.
This pathway imposes stricter limitations on:
- the claims that can be made,
- how SPF is presented,
- labeling and consumer communication.
Correctly determining whether a product qualifies as primary or secondary is critical. Misclassification can result in authorization delays or non-compliance findings.
Recent updates to sunscreen monographs
Recent updates to the sunscreen monographs aim to clarify regulatory expectations and reflect current scientific assessments. While the overall structure of the monographs remains familiar, companies should pay close attention to:
- ingredient eligibility and concentration limits,
- SPF testing documentation,
- updated wording for claims and directions for use.
Products already on the market may require reassessment to confirm continued alignment with the revised monograph criteria.
Updates to the acne therapy monograph
Canada also maintains a dedicated monograph for acne therapy products, covering active ingredients such as benzoyl peroxide and salicylic acid.
Recent updates reinforce:
- concentration thresholds,
- permitted indications,
- required warnings and usage instructions.
These products frequently sit at the boundary between cosmetic and therapeutic categories, making careful classification and claims review particularly important.
Practical implications for companies in 2026
The recent monograph updates do not automatically impose new obligations on all products. However, they do require companies to:
- confirm which monograph applies to each product,
- reassess formulations against updated conditions,
- review labeling and claims language,
- ensure authorization dossiers remain accurate and complete.
Products that no longer fully comply with monograph requirements may need reformulation or a reassessment of their regulatory pathway.
Monographs and multi-market strategies
Canadian monograph requirements often differ from regulatory frameworks in the United States or Europe. A product compliant under a Canadian monograph may still require formulation or claims adjustments for other markets.
Maintaining structured, market-specific regulatory data is essential to manage these differences efficiently and avoid delays in product launches.
Conclusion
The recent updates to Canadian monographs for sunscreens and acne products reflect Health Canada’s ongoing efforts to clarify expectations and align authorization pathways with current scientific standards.
For companies, 2026 should be treated as a review and consolidation year, ensuring that existing and future products remain fully aligned with applicable monographs and regulatory requirements.
Going further
If you have questions about how these monograph updates apply to your products or portfolio, our regulatory team can support you.
You can also subscribe to our cosmetics regulatory newsletter to receive early updates on regulatory developments in Canada, the U.S., and Europe.
