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2022-11-25
Foreword
This monograph is intended to replace the existing Primary Sunscreen Monograph of December 7, 2018. This monograph describes the requirements necessary to receive market authorization [i.e. a Drug Identification Number (DIN) or a Natural Product Number (NPN)], for primary sunscreen products. The monograph identifies the permitted medicinal and non-medicinal ingredients, concentrations, indications, directions and conditions of use for these products to be market authorized without the submission to Health Canada of additional evidence. It also may contain the test methods recommended to be used to comply with the requirements of this monograph. Products which do not meet all of the criteria outlined in this document can apply for market authorization outside of the monograph stream.
Primary sunscreen products are products that are intended to be applied to the skin to prevent sunburn and related conditions of sun exposure. Secondary sunscreen products are products that are intended to be applied to the face or skin as makeup or skincare products and which carry limited sunscreen claims. If no explicit primary cosmetic function is evident from the inner and outer package labels and/or the brand name, then the sunscreen will be deemed to be a primary sunscreen and applicants should reference the Primary Sunscreen Monograph.
Applicants are reminded that primary sunscreen products, like other non-prescription drugs or natural health products, are subject to the Food and Drug Regulations or the Natural Health Products Regulations administered by the Natural and Non-prescription Health Products Directorate (NNHPD). This includes requirements related to labelling, manufacturing and product specifications. Additional information on labels, outside of those specified in the monograph, such as additional directions for use and/or non-therapeutic claims are acceptable as long as they meet the Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims, the Guidelines for Consumer Advertising of Health products for Nonprescription drugs, Natural Health Products, Vaccines and Medical Devices, and are not false, misleading or counterintuitive to the use of the product.
The development of this monograph is the result of a thorough review of existing regulations, guidance documents, policies and current practices within Health Canada and other leading regulatory agencies.
Note:
The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. Text in parentheses is additional optional information which can be included on the Product Licence Application form and label at the applicant's discretion.
Primary sunscreen products are classified as natural health products (NHPs) if they contain only ingredients from Table 1. Applicants applying for an NPN can access the appropriate forms and guidance at: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription.html.
Primary sunscreen products are classified as non-prescription drugs if they contain at least one ingredient from Table 2. Applicants applying for a DIN can access the appropriate forms and guidance at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html.
Any combination of medicinal ingredients listed in Tables 1 and 2 are permitted, provided that the individual concentration limits outlined in the tables are respected.
Proper name(s)1 | Common name(s)1 | Source information1,2 | UV Protection3 | Quantity4 | ||
---|---|---|---|---|---|---|
Source ingredient(s) | ||||||
Titanium dioxide |
|
Titanium dioxide |
UVA UVB |
≤25% |
||
Zinc oxide |
|
Zinc oxide |
UVA UVB |
≤25% |
||
Table 1 Footnotes
|
Proper name(s) | Common name(s) | Source information | UV Protection | Quantity |
---|---|---|---|---|
Source ingredient(s) | ||||
|
Avobenzone |
Avobenzone |
UVA I |
≤3% |
2,2'-[6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis(5-[(2-ethylhexyl)oxy]phenol) |
Bemotrizinol |
Bemotrizinol |
UVA UVB |
≤6%1 |
|
|
Oxybenzone |
UVA II UVB |
≤6% |
|
|
Sulisobenzone |
UVA II UVB |
≤10% |
|
|
Dioxybenzone |
UVA II UVB |
≤3% |
2,2'-Methylenebis-(6-(2H-benzotriazol-2yl)-4-( 1,1,3,3-tetramethylbutyl)-phenol) |
Bisoctrizole |
Bisoctrizole |
UVA UVB |
≤5%1 |
|
Cinoxate |
Cinoxate |
UVB |
≤3% |
|
|
Diethanolamine methoxycinnamate |
UVB |
≤10% |
2-(2H-Benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-{1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl}propyl)phenol |
Drometrizole trisiloxane |
Drometrizole trisiloxane |
UVA UVB |
≤15% |
|
Ecamsule |
Ecamsule |
UVA UVB |
≤10% |
|
Ensulizole |
Ensulizole |
UVB |
≤4% |
|
Enzacamene |
Enzacamene |
UVB |
≤4% |
|
|
Homosalate |
UVB |
≤15% |
|
|
Meradimate |
UVA II |
≤5% |
|
|
Octinoxate |
UVB |
≤7.5% |
|
Octisalate |
Octisalate |
UVB |
≤5% |
|
|
Octocrylene |
UVA II UVB |
≤10% |
|
Padimate O |
Padimate O |
UVB |
≤8% |
|
|
Trolamine salicylate |
UVB |
≤12% |
Table 2 Footnotes
|
Topical
Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.
Self-Care Framework Category I Uses or Purposes:
For all products, the following statement must be made:
For all products, the following statements may be made:
For products with a critical wavelength of ≥ 370 nm** and with medicinal ingredient(s) that provide UVA and UVB protection, the following statement may be made:
For products with a critical wavelength of ≥ 370 nm**, with medicinal ingredient(s) that provide UVA and UVB protection, and SPF ≥15, the following statements may be made:
For products that are water resistant***, the following statement may be made:
Self-Care Framework non-Category I Uses or Purposes:
For products with a critical wavelength of ≥ 370 nm, with medicinal ingredient(s) that provide UVA and UVB protection, and SPF ≥15, the following statement may be made:
* As determined using a standardized and reproducible method, such as the one referenced in US FDA 2012 or as ISO 2010. The SPF value must be ≥2 and values greater than 50 are to be declared as SPF 50+.
** As determined using a standardized and reproducible method, such as the one referenced in US FDA 2012 or as ISO 2012 and Colipa 2011.
*** As determined using a standardized and reproducible method, such as the one referenced in US FDA 2012 or as Colipa 2005. When the Colipa methodology is used, the labelled SPF value must be the SPF value of the final product formulation determined following immersion (Antoniou et al. 2008).
Infants 6 to 12 months, Children 1 to 11 years, Adolescents 12 to 17 years, Adults 18 years and older.
See Tables 1 and 2.
For all products excluding sprays:
For spray products:
For all products, the following direction may be included:
For products that are non-water resistant:
For products that are water resistant:
For products that are applied to the lips:
No statement is required.
For all products:
****Note: This warning statement must appear on the outer label of all primary sunscreen products, and is ineligible for Level 4 Graduated and Labelling for Low-Risk Non-prescription Drugs (Category I) flexibilities as described in the Guidance Document: Labelling Requirements for Non-prescription Drugs.
For products with a critical wavelength of < 370 nm or with SPF value of <15:
For all products:
No statement required.
Ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR), and the current Cosmetic Ingredient Hotlist, when relevant.
No statement required.
This monograph describes those requirements that are specific to this class of non-prescription drugs and to NHPs. Any change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. nanotechnology), requires supporting data and will be reviewed outside the monograph.
For products containing Table 1 NHP medicinal ingredients only:
The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide. The medicinal ingredient must comply with the requirements outlined in the NHPID.
Applicants for market authorizations of sunscreen products formulated with nano Zinc oxide and/or nano Titanium dioxide, meeting the Health Canada's working definition of nanomaterial, are expected to gather and keep information as outlined in Section 7 of the Policy Statement on Health Canada's Working Definition for Nanomaterial. This information is required to be made available to Health Canada upon request.
For products containing Table 2 non-prescription drug medicinal ingredients:
Requirements described in the Regulations to the Food and Drugs Act must be met.
DRUG FACTS TABLE (Format Optional for Self-Care Category I)
*Note: This warning statement must appear on the outer label of all primary sunscreen products, and is ineligible for Level 4 Graduated and Labelling for Low-Risk Non-prescription Drugs (Category I) flexibilities as described in the Guidance Document: Labelling Requirements for Non-prescription Drugs.
Unacceptable use(s) or purpose(s) which are misleading or counterintuitive to the safety and efficacy of sunscreen use:
Statement(s) to the effect of:
Unacceptable use(s) or purpose(s) which require assessment of supporting scientific data outside of the Monograph:
Statement(s) to the effect of: