Primary Sunscreen Monograph

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Date

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.

Medicinal Ingredient(s)

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.

Table 1: NHP medicinal ingredients
Proper name(s)1 Common name(s)1 Source information1,2 UV Protection3 Quantity4
Source ingredient(s)

Titanium dioxide

  • C.I. No. 77891
  • Titanium dioxide
  • Titanic anhydride

Titanium dioxide

UVA

UVB

≤25%

Zinc oxide

  • C.I. No. 77947
  • Zinc oxide

Zinc oxide

UVA

UVB

≤25%

Table 1 Footnotes

Table 1 Footnote 1

At least one of the following references was consulted per proper name, common name and source information: O'Neil et al. 2018; TGA 2016; Nikitakis and Lange 2016; USP 41.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

Ingredient must be pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Quality of Natural Health Products Guide).

Return to Table 1 footnote2 referrer

Table 2 Footnote 3

At least one of the following references was consulted for UV protection: Wang et al. 2010; Antoniou et al. 2008; Ferguson and Dover 2006.

Return to Table 1 footnote3 referrer

Table 1 Footnote 4

At least one of the following references was consulted for the dosage: TGA 2016; Wang et al. 2010; US FDA 1999.

Return to Table 1 footnote4 referrer

Table 2: Non-prescription drug medicinal ingredients
Proper name(s) Common name(s) Source information UV Protection Quantity
Source ingredient(s)
  • 1-(p-tert-Butylphenyl)-3-(p-methoxyphenyl)-1,3-propanedione
  • 1-[4-(1,1-Dimethylethyl)phenyl]-3-(4-methoxyphenyl)-1,3-propanedione
  • 4-tert-Butyl-4'-methoxydibenzoylmethane

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

  • (2-Hydroxy-4-methoxyphenyl)phenylmethanone
  • 2-Hydroxy-4-methoxybenzophenone
  • Benzophenone-3
  • Oxybenzone

Oxybenzone

UVA II

UVB

≤6%

  • 2-Benzoyl-5-methoxy-1-phenol-4-sulfonic acid
  • 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid
  • 3-Benzoyl-4-hydroxy-6-methoxybenzenesulfonic acid
  • 5-Benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid
  • Benzophenone-4
  • Sulisobenzone

Sulisobenzone

UVA II

UVB

≤10%

  • (2-Hydroxy-4-methoxyphenyl)(2-hydroxyphenyl)methanone
  • 2,2'-Dihydroxy-4-methoxybenzophenone
  • Benzophenone-8
  • Dioxybenzone

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

  • 2-Ethoxyethyl p-methoxycinnamate
  • 3-(4-Methoxyphenyl)-2-propenoic acid 2-ethoxyethyl ester

Cinoxate

Cinoxate

UVB

≤3%

  • 3-(4-Methoxyphenyl)-2-propenoic acid, compd. with 2,2'-iminobis(ethanol) (1:1)
  • p-Methoxycinnamic acid, compound with 2,2'-iminodiethanol (1:1)
  • DEA-methoxycinnamate
  • Diethanolamine methoxycinnamate

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%

  • (+-)-(3E,3'E)-(p-Phenylenedimethylidyne)bis[2-oxo-10-bornanesulfonic acid]
  • 3,3'-(1,4 Phenylenedimethylidene)bis(7,7-dimethyl-2-oxobicyclo[2.2.1]heptane-1- methanesulfonic acid)
  • Terephthalylidene-3,3'-dicamphor-10,10'-disulfonic acid
  • Terephthalylidene dicamphor sulfonic acid

Ecamsule

Ecamsule

UVA

UVB

≤10%

  • 2-Phenyl-1H-benzimidazole-5-sulphonic acid
  • 2-Phenylbenzimidazole-5-sulfonic acid

Ensulizole

Ensulizole

UVB

≤4%

  • (±)-3-(p-Methylbenzylidene)camphor
  • 1,7,7-Trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one

Enzacamene

Enzacamene

UVB

≤4%

  • 2-Hydroxybenzoic acid 3,3,5-trimethylcyclohexyl ester
  • 3,3,5-Trimethylcyclohexyl salicylate
  • Salicylic acid 3,3,5-trimethylcyclohexyl ester
  • Homomenthyl salicylate
  • Homosalate

Homosalate

UVB

≤15%

  • 5-Methyl-2-(1-methylethyl)cyclohexanol 2-aminobenzoate
  • Anthranilic acid, p-menth-3-yl ester
  • Menthyl anthranilate
  • Meradimate

Meradimate

UVA II

≤5%

  • 2-Ethylhexyl p-methoxycinnamate
  • 3-(4-Methoxyphenyl)-2-propenoic acid, 2-ethylhexyl ester
  • Octinoxate
  • Octyl methoxycinnamate

Octinoxate

UVB

≤7.5%

  • 2-Ethylhexyl salicylate
  • 2-Hydroxybenzoic acid 2-ethylhexyl ester

Octisalate

Octisalate

UVB

≤5%

  • 2-Cyano-3,3-diphenyl-2-propenoic acid, 2-ethylhexyl ester
  • 2-Ethylhexyl-2-cyano-3,3-diphenylacrylate
  • Octocrilene
  • Octocrylene

Octocrylene

UVA II

UVB

≤10%

  • 2-Ethylhexyl p-(dimethylamino)benzoate
  • 4-(Dimethylamino)benzoic acid, 2-ethylhexyl ester

Padimate O

Padimate O

UVB

≤8%

  • 2-Hydroxybenzoic acid, compd. with 2,2',2''-nitrilotris(ethanol) (1:1)
  • Salicylic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
  • Triethanolamine salicylate
  • Trolamine salicylate

Trolamine salicylate

UVB

≤12%

Table 2 Footnotes

Table 2 Footnote 1

Only permitted when combined with (an) ingredient(s) listed in Table 1 or 2.

Return to Table 2 footnote1 referrer

Route of Administration

Topical

Dosage Form(s)

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.

Use(s) or Purpose(s)

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).

Dose(s)

Subpopulation(s)

Infants 6 to 12 months, Children 1 to 11 years, Adolescents 12 to 17 years, Adults 18 years and older.

Quantity

See Tables 1 and 2.

Direction(s) for use

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:

Duration(s) of Use

No statement is required.

Risk Information

Caution(s) and warning(s)

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:

Contraindication(s)

For all products:

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

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.

Storage conditions

No statement required.

Specifications

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)

Drug Facts Table

*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.

References

Appendix 1: Unacceptable Use(s) or Purpose(s)

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: