Summertime has finally arrived and with it comes hot temperatures and intense ultraviolet rays. Exposure to ultraviolet light is known to be associated with early skin aging and skin cancer. While the best protection from the sun is to avoid exposure altogether there are times when this is not possible. Using an appropriately regulated sunscreen can offer protection from the sun’s harmful rays.
If you are looking to market sunscreen in Canada or the United States, there are a few things to consider.
Canadian Sunscreen Requirements
In Canada, sunscreens can be classified as either Natural Health Products (NHPs) or non-prescription drugs, depending on the ingredients they contain. Commonly used natural ingredients include titanium dioxide, zinc oxide, and p-aminobenzoic acid. Marketing a product containing these ingredients would require a Natural Product Number (NPN) unless the product also contains ingredients that are not naturally derived, such as avobenzone, oxybenzone, octinoxate, or other recognized drug ingredients as outlined in the Natural and Non-Prescription Health Products Directorate’s (NNHPD’s) sunscreen monograph. For products that contain drug ingredients, a Drug Identification Number (DIN) would be required.
It is important to note that all Canadian sunscreen products must include a statement to the effect of “helps prevent sunburn” and display the appropriate Sun Protection Factor (SPF) value on the label. Companies are also permitted to market their sunscreen products with a ‘Broad Spectrum SPF’ value provided that test results demonstrate a critical wavelength of? 370 nm for the product.
There are however a few labeling statements that are not permitted by Health Canada. Statements that suggest the product completely blocks the penetration of the sun’s rays (e.g. sunblock) are not acceptable. Those that suggest the product helps to prevent cancer or photo-aging are also not permitted and the product cannot claim to filter out other UV rays apart from UVA/UVB. These are not the only non-permitted statements but rather are those which are most commonly misused.
In summary, if you are looking to market a sunscreen in Canada, you need to determine whether it will be classified as a drug or an NHP, prepare the appropriate application, and label your product according to the criteria as set out in the NNHPD sunscreen monograph and the appropriate set of governing regulations.
key requirements you should be aware of before bringing your sunscreen product to the Canadian market:
Product Classification and Registration:
- In Canada, sunscreens are classified as natural health products (NHPs) or non-prescription drugs, depending on their active ingredients and intended use. Check the classification of your product to determine the applicable regulatory pathway.
- If your sunscreen is classified as an NHP, you need to apply for product registration with the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada.
- If your sunscreen is classified as a non-prescription drug, you must follow the regulatory requirements outlined by Health Canada’s Health Products and Food Branch (HPFB).
Labeling and Packaging Requirements:
- Sunscreen product labels must be bilingual (English and French) and meet specific format and content requirements outlined in the Food and Drugs Act and Regulations.
- Labels should include the product’s drug identification number (DIN) or natural product number (NPN) if applicable.
- Ensure accurate SPF (Sun Protection Factor) labeling and UV protection claims.
- Sunscreens must also include usage instructions, precautions, and any required warnings.
Sun Protection Factor (SPF) Testing:
- SPF testing is essential to determine the effectiveness of your sunscreen product. Testing should be conducted by Health Canada’s guidelines.
- Ensure that your product provides the level of sun protection claimed on the label.
Safety and Efficacy Data:
- Provide data on the safety and efficacy of your sunscreen product, including information on the active ingredients, formulation, and potential side effects.
- Ensure that your product is safe for use on the skin and does not cause adverse reactions.
- Conduct stability testing to assess the product’s shelf life and ensure that it maintains its effectiveness and safety over time.
- Data from stability studies should be submitted to Health Canada as part of the regulatory requirements.
- Comply with GMP standards to ensure the quality, safety, and consistency of your sunscreen product.
- Facilities involved in the production of sunscreen should adhere to GMP guidelines.
Notification and Reporting:
- Report any adverse reactions or safety issues associated with your sunscreen product to Health Canada promptly.
- Maintain records of complaints and adverse events and provide these to Health Canada as needed.
Packaging and Dosage Forms:
- Ensure that your sunscreen product’s packaging and dosage forms meet Health Canada’s requirements and guidelines.
- Different dosage forms, such as creams, lotions, sprays, and sticks, may have specific regulatory considerations.
Health Canada Notifications and Submissions:
- Prepare and submit all required documentation, including product labeling, safety and efficacy data, stability testing results, and any other relevant information, to Health Canada.
- Comply with Health Canada’s notification and submission procedures and timelines.
Compliance with International Standards:
- Familiarize yourself with international sunscreen standards, such as those from the International Organization for Standardization (ISO), and align your product with these standards for broader market acceptance.
Market Surveillance and Compliance Reporting:
- Implement a system for market surveillance to monitor the safety and compliance of your sunscreen product after it is on the market.
- Report any updates or changes to the product, labeling, or formulation to Health Canada as required.
It is essential to work closely with regulatory experts or consultants familiar with Canadian sunscreen regulations to navigate the complex requirements effectively. Failing to meet these regulatory obligations can result in delays in product approval or market withdrawal, potentially harming your business’s reputation. Compliance with Canadian sunscreen regulations ensures that your product is safe and effective for consumers in the Canadian market.
U.S. Sunscreen Requirements
Sunscreens in the United States are regulated as drugs through 2 pathways:
- The Over-the-Counter (OTC) monograph process outlined in 21 CFR part 330 and accordance with the Sunscreen Innovation Act (SIA), or
- The new drug approval process is outlined in 21 CFR part 314.
The United States Food and Drug Administration (FDA) has categorized sunscreen products by type and published several final rules. If you are looking to market a sunscreen product in the U.S., it is advisable to consult the FDA’s published final rules to verify if your product meets the indicated conditions. If the conditions as set out by the FDA are met and the product also complies with the FDA’s general regulations for OTC drugs then the FDA considers the sunscreen to be Generally Recognized as Safe and Effective (GRASE) and not misbranded.
Regulation through the OTC monographs was once the only option for sunscreen products, but in 2014, the FDA published the Sunscreen Innovation Act (SIA) to allow for an expedited review process for new sunscreen ingredients. The SIA functions to supplement the Time and Extent Application (TEA) regulation, as outlined in 21 CFR part 330.14(c), which together allows anyone (not only sponsors) to request that an active sunscreen ingredient be recognized as GRASE and not misbranded when used by the criteria set out in a final sunscreen order. This collaborative framework has allowed for a new process by which OTC active sunscreen ingredients or combinations of ingredients can be deemed GRASE and not misbranded when used according to the conditions set out in an administrative order.
To gain GRASE status for a new sunscreen ingredient, initial eligibility of the ingredient is determined by the FDA. If the ingredient is deemed eligible for review, data supporting the safety and efficacy of the ingredient is to be submitted by either the sponsor or the public. If the provided evidence is deemed acceptable, a final GRASE determination in the form of an administrative order is made by the FDA within 60 days of data submission.
In summary, if you are looking to market a sunscreen product in the U.S., it is advisable to first check the OTC final rules for sunscreens and if your ingredient(s) is/are not present, then look into preparing a GRASE data submission.
If you are looking to expand your business into the U.S. or Canadian sunscreen market, we can assist you in confirming which regulatory framework best suits your innovative sunscreen product. Contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert who has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, and OTC drugs.
Non-prescription Sunscreen Drug Products – Format and Content of Data Submissions. Guidance for Industry. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Nov 2006.
Regulatory Policy Information for the Sunscreen Innovation Act. U.S. Food and Drug Administration. May 22, 2018. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm434843.htm
Rulemaking History for OTC Sunscreen Drug Products. U.S. Food and Drug Administration. April 27, 2018. https://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/over-the-counterotcdrugs/statusofotcrulemakings/ucm072134.htm#time
Sunscreen Innovation Act. November 26, 2014. https://www.congress.gov/bill/113th-congress/senate-bill/2141/text
Sunscreen Monograph – Version 2.0. Health Canada. July 7, 2013. http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=sunscreen-ecransolaire&lang=eng