Here is a simplified breakdown of what has changed and what it means for your product labels:

Sunscreen Monograph Updates:

• Nano Ingredients Recognized: The monographs now explicitly include data on nano titanium dioxide and nano zinc oxide, covering acceptable quantities, dosage forms, and specifications.
• New Filters Added: Bemotrizinol and Bisoctrizole have been added to the Secondary Sunscreen monograph.
• Testing Standards: New in vitro methods for SPF and broad-spectrum testing (e.g., ISO 23675, ISO 23698) are now referenced.
• PA Ratings (UVA Protection): For NHPs and Non-prescription Drugs (NPDs), PA ratings are now permitted as “additional information” on the label. For NPDs, data must be provided to support any additional information regarding the PA rating prior to its use on labels. The PA rating is acceptable as additional information on the label for NHPs containing Zinc Oxide or a combination of Zinc Oxide and Titanium Dioxide. It does not apply to Titanium Dioxide alone (due to lower efficacy against long-wave UVA).

Acne Therapy Monograph Updates:

• More flexibility for marketing claims (expanded terminology): You are no longer restricted to just “acne pimples.” The monograph now allows interchangeable terms such as “zits,” “blemishes,” “spots,” “blackheads,” “whiteheads,” and “comedones.”
• New Performance Claims: Added support for claims regarding mechanism of action, such as “Penetrates pores to eliminate most acne pimples” or “For the management of acne breakouts.”
• Quantity Labeling: You now have the option to express quantity as % w/w or % w/v, depending on your specific formulation.

General Updates for Both Categories:

• Product Facts Table: A standardized Product Facts Table has been added for NHPs in these categories to improve consumer readability.
• Dosage Forms: An updated list of acceptable dosage forms is now included.

The NNHPD has indicated that under this Monograph Update Project, no modifications are anticipated that would necessitate mandatory product license amendments or label revisions. Essentially, these updates are intended to offer more flexibility and modernization rather than forcing a compliance overhaul of existing products. However, if you are launching new products, you should align with these new standards immediately.

Need help navigating these changes? Do you have questions about how these monograph updates affect your specific formulations or labeling strategies? Feel free to reach out to us.

The post Key Changes to Health Canada’s Acne & Sunscreen Monographs appeared first on Focal Point.

Newly Published Monographs (July 25, 2025):

1. Green tea extract
2. Hydrocortisone- topical
3. Serrapeptase
4. L-Carnitine
5. Ginkgo biloba
6. Aromatherapy

In addition, revisions have been made to the following monographs:

1. Dandelion
2. Workout Supplements
3. L-Arginine
4. Antioxidants
5. Cognitive function products

Companies should review the updated monographs to ensure their products comply with the latest requirements. If you have questions or need help assessing the impact on your product line, feel free to reach out to us.

The post Health Canada Monograph Updates appeared first on Focal Point.