During February’s monthly updates of the Natural Health Products Ingredients Database (NHPID), NNHPD made minor updates to both the Primary and Secondary Sunscreen Monographs.
The purpose of the update is to provide clarity on the regulatory requirements for sunscreen products in Canada, to ensure compliance and successful market entry.
Here is a complete summary of the changes:
Primary Sunscreen Monograph
- Revision of the ‘Sun Protection Measures’ Directions for use statement to:
- include the timeframe option of 10 a.m. – 2 p.m. back; and
- add an additional timeframe option of 10 a.m. – 3 p.m.; and
- also an asterisk on the timeframe of ‘11 a.m. – 3 p.m.’ accompanied by a note to industry indicating that in Canada, the sun’s UV rays are strongest between 11 a.m. and 3 p.m.
- Revision of the Product Facts Table for Non-Prescription Drugs (NPDs)
Secondary Sunscreen Monograph
- Revision of the Product Facts Table for Natural Health Products (NHPs) to fix errors in the listed claims
Common updates across both Monographs:
- Removal of the footnote in Table 2 associated with Bemotrizinol and Bisoctrizole.
- The footnote previously indicated that these ingredients were only permitted when combined with (an) ingredient(s) listed in Tables 1 or 2.
- Removal of the specific ‘Self-Care Framework non-Category I Uses or Purposes’ section title and replaced it with a note regarding labelling requirements.
- See monographs for the complete note.
- Inclusion of version history information.
- Outlines all dates when updates to the monograph have been made and provides a summary of the main updates.
Given the updates detailed above, there are likely no mandatory product license amendments or label changes required with these updates. If you are unsure how these updates relate to your products or you are looking to update your product labels, feel free to contact us.
