Health Canada Drug Identification Number (DIN) Registration for Sunscreen Products

To legally market and sell sunscreen products in Canada, manufacturers must comply with Health Canada’s sunscreen approval process. Depending on the formulation, your sunscreen may require DIN registration or Natural Health Product (NHP) approval. Ensuring compliance with Canada’s sunscreen monograph and regulatory requirements are crucial to avoid delays in obtaining market authorization.

How to Register a Sunscreen in Canada

The sunscreen product registration process in Canada varies based on the product classification:

Classification of Sunscreens

Over-the-Counter (OTC) sunscreens in Canada are categorized as either Non-prescription drugs or Natural Health Products (NHPs), based on their active ingredients:

  1. NHP Registration: Sunscreens that meet the criteria of the NHP framework require an NPN (Natural Product Number) instead of a DIN. These contain ingredients such as Titanium Dioxide TiO2 or Zinc Oxide (ZnO) without additional active ingredients.
  2. DIN Registration: Products containing active pharmaceutical ingredients (APIs) such as Titanium Dioxide (TiO2) or Zinc Oxide (ZnO) in addition to another active ingredient require a Drug Identification Number (DIN)

Primary Sunscreens Vs. Secondary Sunscreens

Understanding whether your product falls under primary sunscreen registration or secondary sunscreen registration is a critical first step:

  1. Primary sunscreens are products that are intended to be applied to the skin to prevent sunburn and related conditions of sun exposure.
  2. Secondary sunscreens are products that are intended to be applied to the face or skin as makeup / skincare and which carry limited sunscreen claims.

Compliance with Health Canada’s Monograph

Sunscreens must comply with the Canada sunscreen monographs, which outline permitted active ingredients, dosage limits, and labeling requirements. The primary sunscreen monograph applies to products with sunscreen as their main function, while the secondary sunscreen monograph applies to products where sun protection is a secondary benefit.

Application Process for Sunscreen DIN Registration

The Health Canada sunscreen registration process includes:

  1. Preparation of a Drug Submission: This includes detailed product formulation, safety data, and compliance with sunscreen label requirements Canada.
  2. Submission to Health Canada: The application must align with the Health Canada authorization of sunscreens framework.
  3. Regulatory Review and Compliance Checks: Health Canada will assess the application for adherence to safety and efficacy standards.

For importing sunscreens to Canada, additional importation and labeling compliance steps may be required.

Sunscreen Registration Timelines in Canada

The approval process varies based on product classification:

  1. DIN Registration for Sunscreens: Typically takes 6-12 months.
  2. NPN Approval for Sunscreens: Takes approximately 4-6 months.
  3. New Drug Submissions for non-monographed Sunscreens: Can take 12-24 months, depending on data requirements.

Timelines can vary based on Health Canada’s workload and the completeness of the application.

Regulatory Compliance for SPF Products in Canada

Health Canada requires sunscreens to meet stringent regulatory standards. Common compliance areas include:

  1. Sunscreen label requirements Canada: Labeling must include SPF, broad-spectrum protection claims, and bilingual text.
  2. Broad-spectrum sunscreen licensing: Products must meet UVA/UVB protection requirements.
  3. Health Canada sunscreen compliance consultants: Many manufacturers work with regulatory experts to navigate the approval process.
  4. Annual payment for the right to sell drugs : After the market authorization of a drug in Canada, an annual fee must be paid to maintain the right to sell the drug. Fees are charged for 12-month period which begins October 1 and ends September 30 of the following year by Health Canada. Failure to submit payment can result in withhold of services, approvals, or rights and privileges from Health Canada.

Start Your Sunscreen Registration Today

Understanding how to get sunscreen approved in Canada is a complex process, but our regulatory experts can guide you through every step. If you need assistance with sunscreen approval services Canada, contact us today.