Summary Safety Review - Sunscreen products - Assessing the potential risk of skin reactions
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2018-11-26
Product
Sunscreen products (chemical action sunscreens)
Potential Safety Issue
Skin reactions
Overview
Use in Canada
- Sunscreen products are authorized for sale in Canada to help prevent sunburns.
- There are currently over 1,600 authorized sunscreen products in Canada. All sunscreen products contain one or more active ingredients that offer protection from UV rays. Sunscreen products may contain chemical UV filters, physical UV filters, or both.
- Chemical UV filters (e.g., avobenzone, homosalate, octocrylene, octisalate, octinoxate, or oxybenzone) work by absorbing UV radiation and converting it into a small amount of heat. These chemical UV filters are usually classified by Health Canada as drug ingredients, and have an 8-digit Drug Identification Number (DIN) on the label of products that contain them.
- Physical UV filters (e.g., zinc oxide and titanium dioxide) are mineral compounds that are believed to work by scattering and reflecting UV rays. These physical UV filters are usually classified by Health Canada as natural ingredients, and products containing only this type of UV filter have an 8-digit Natural Product Number (NPN) on the label.
- Combination sunscreens that contain both chemical and physical UV filters have an 8-digit Drug Identification Number (DIN) on the label.
Safety Review Findings
- From January 2016 to August 2017, Health Canada received 346 unique Canadian reportsa of skin reactions with the use of sunscreen products containing chemical UV filters.
- Of the 346 reports, there were 97 cases which described skin reactions including blisters. Of these 97 cases, 20 were found to be potentially linked to the use of the sunscreen product, while the remaining 77 could not be assessed due to missing information. These 20 cases were not confirmed by healthcare professionals and were missing important medical and diagnostic information. As a result, the possibility of sunburn due to sun exposure could not be ruled out as the cause of the reported skin reaction.
- The remaining 249 of 346 Canadian reports generally described mild to moderate local skin reactions (e.g., itchy skin rashes which may reflect allergic contact dermatitis).
- A search in the World Health Organization's Adverse Drug Reaction Database found 35 international reports of side effects involving the skin with the use of sunscreen products. However, none of these reports could be assessed by Health Canada due to missing information.
- The safety review also considered published scientific studies about skin reactions with the use of sunscreen products. Publications confirm that medicinal and/or non-medicinal ingredients in sunscreen products (i.e., UV filters, fragrances, and preservatives) are known to potentially cause mild to moderate skin reactions in individuals who are sensitive or allergic to these ingredients.
- Cases of skin reactions with the use of sunscreen products continue to be reported in Canada and internationally. However, considering the very large number of Canadians using sunscreen products (millions of units sold annually), there are relatively few reports and, therefore, these skin reactions are considered rare.
- The benefits of the regular use of sunscreen to prevent sunburn and reduce one's risk of skin cancer continue to heavily outweigh any risk of local skin reactions.
Conclusions and actions
- Health Canada's review found that rare, mild to moderate skin reactions may occur in certain individuals who have an allergy or sensitivity to one or more ingredients in a sunscreen product. The review also found that this risk is already considered within Health Canada's sunscreen product information (also known as the monograph).
- An Information Update, in addition to educational materials and content, will be published to increase consumers' awareness and understanding of this risk. The Information Update will help educate Canadians and healthcare professionals about general sun safety, the proper use of sunscreen, and the rare possibility of skin reactions. The educational material will also improve consumer awareness and knowledge of safe sunscreen use, such as testing sunscreen products on a small area of skin before first use (in babies and children, or on sensitive skin).
- Health Canada encourages consumers and healthcare professionals to report any side effects or reactions related to the use of sunscreen or other health products.
- Health Canada will continue to monitor safety information involving sunscreen products, as it does for all health products on the Canadian market, in order to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of these products both in Canada and internationally.
- Information Update: Summary Safety Review: Health Canada concludes that there are no new safety concerns with sunscreen products
- 2018 report on compliance monitoring: Sunscreen testing
- Information about sun safety and sunscreens
For additional information, contact the Marketed Health Products Directorate.
Footnotes
- Canadian reports can be accessed through the Canada Vigilance Online Database.