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Drugs and Health Products

Sunscreen Monograph - Version 2.0

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Foreword

Health Canada is pleased to announce the release of the final Sunburn Protectants Monograph. The document is now titled "Sunscreen Monograph" to reflect the common Canadian term for this category of products.

This monograph is intended to replace the existing Sunburn Protectants Monograph of October 12, 2006. This monograph describes the requirements necessary to receive market authorization [i.e. a Drug Identification Number (DIN) or a Natural Product Number (NPN)], for topical sunscreen products. The monograph identifies the permitted medicinal and nonmedicinal ingredients, concentrations, indications, directions and conditions of use for these products to be licensed without the submission to Health Canada of additional evidence. It also contains the test methods recommended to be used to comply with the requirements of this monograph. Products which do not meet the criteria outlined in this document can apply for market authorization outside of the monograph stream.

Applicants are reminded that sunscreens, like other drugs or natural health products, are subject to the Food and Drug Regulations administered by the Therapeutic Products Directorate (TPD) or the Natural Health Products Regulations administered by the Natural Health Products Directorate (NHPD). 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 cosmetic claims are acceptable as long as they meet the Guidelines for Cosmetic Advertising and Labelling Claims or are not false, misleading or counterintuitive to the use of the product.

The development of this monograph is the result of a thorough survey of existing regulations, guidance documents, policies and current practices within Health Canada and other leading regulatory agencies.

Date

July 7, 2013

Medicinal Ingredient(s)

Sunscreens are classified as natural health products (NHPs) if they contain medicinal ingredients from Table 1 only. Applicants applying for an NPN should use the appropriate forms, templates, and guidance.

Sunscreens are classified as drugs if they contain one or more of the medicinal ingredients from Table 2 or a combination of medicinal ingredients from Tables 1 and 2. Applicants applying for a DIN should use the appropriate forms, templates, and guidance.

Any combination of medicinal ingredients listed in Tables 1 and 2 are permitted, provided that the individual concentration limitations outlined in the tables are respected.

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 Nanomaterial1. This information is required to be made available to Health Canada upon request.

Table 1: NHP Medicinal Ingredients, Source Ingredients and Concentrations
Proper name2 Common name2 Source ingredient UV protection3 Concentration4

Table 1 Footnotes

Table 1 Footnote 1

Health Canada 2011a

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

At least one of the following references was consulted: TGA 2012; CTFA 2008; USP 34; Merck Index 2006

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

At least one of the following references was consulted: 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: TGA 2012; Wang et al. 2010; US FDA 1999

Return to Table 1 footnote4 referrer

Titanium dioxide (TiO2) Titanium dioxide Titanium dioxide UVA
UVB
≤ 25%
Zinc oxide (ZnO) Zinc oxide Zinc oxide UVB
UVA
≤ 25%
4-Aminobenzoic acid
  • p-Aminobenzoic acid
  • PABA
p-Aminobenzoic acid UVA ≤ 15%
Table 2: Drug Medicinal Ingredients, Synonyms and Concentrations
Medicinal ingredient preferred name5 Synonym(s)2 UV protection6 Concentration7

Table 2 Footnotes

Table 2 Footnote 5

At least one of the following references was consulted: TGA 2012; US FDA 2010; CTFA 2008; USP 34; Merck Index 2006

Return to Table 2 footnote5 referrer

Table 2 Footnote 6

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

Return to Table 2 footnote6 referrer

Table 2 Footnote 7

At least one of the following references was consulted: TGA 2012; US FDA 2010; Wang et al. 2010; US FDA 1999

Return to Table 2 footnote7 referrer

Avobenzone Butyl methoxydibenzoylmethane UVA I ≤ 3%
Ensulizole 2-Phenylbenzimidazole-5-sulfonic acid UVB ≤ 4%
Homosalate Homomenthyl salicylate UVB ≤ 15%
Meradimate
  • Menthyl 2-aminobenzoate
  • Menthyl anthranilate
UVA II ≤ 5%
Octinoxate
  • 2-Ethylhexyl methoxycinnamate
  • Octyl methoxycinnamate
UVB ≤ 7.5%
Octisalate
  • 2-Ethylhexyl salicylate
  • Octyl salicylate
UVB ≤ 5%
Octocrylene 2-Ethylhexyl-2-cyano-3,3 diphenylacrylate UVA II
UVB
≤ 10%
Oxybenzone
  • Benzophenone-3
  • 2-Hydroxy-4-methoxybenzophenone
UVA II
UVB
≤ 6%
Sulisobenzone Benzophenone-4 UVA II
UVB
≤ 10%
Drometrizole trisiloxane Meroxyl XL UVA
UVB
≤ 15%
Enzacamene 4-Methylbenzylidene camphor UVB ≤ 4%
Padimate O Octyl dimethyl PABA UVB ≤ 8%
Ecamsule
  • Mexoryl SX
  • Terephthalylidene dicamphor sulfonic acid
  • 3,3'-(1,4 Phenylenedimethylidene)bis[ 7,7-dimethyl-2- oxobicyclo[2.2.1]heptane-1- methanesulfonic acid
UVA
UVB
≤ 10%
Cinoxate 2-Ethoxyethyl-pmethoxycinnamate UVB ≤ 3%
Diethanolamine methoxycinnamate DEA-methoxycinnamate UVB ≤ 10%
Dioxybenzone
  • Benzophenone-8
  • (2-Hydroxy-4-methoxyphenyl) (2-hydroxyphenyl)methanone
UVA II
UVB
≤ 3%
Triethanolamine salicylate Trolamine salicylate UVB ≤ 12%

Route of administration

Topical

Dosage form(s)

The only acceptable dosage forms are balm, butter, cream, emulsion, gel, lotion, mousse, oil, ointment, powder, paste, spray [including non-pressurized sprays, continuous (bag-on-valve) sprays, and aerosol {non-chlorofluorocarbons (CFC)}-based sprays], stick, and suspension.

Use(s) or Purpose(s)8

Statement(s) to the effect of9:

For all products:

  • Helps prevent sunburn; and
  • Sun Protection Factor "X" or SPF "X"10,11

For products with a critical wavelength of ≥ 370 nm12, the following statement may be made:

Broad Spectrum SPF "X".

For products with a critical wavelength of ≥ 370 nm and SPF ≥ 15, the following statement may be made:

If used as directed with other sun protection measures [see Directions for Use], decreases the risk of skin cancer and early skin aging caused by the sun.

For products that are water resistant13, the following statements may be made:

  • Water/Sweat Resistant [40 minutes]; or
  • Water/Sweat Resistant [80 minutes].

Dose(s)

Subpopulation(s)

Subpopulation does not need to be specified.

Direction(s) for Use14

Statement(s) to the effect of

For all products:
  • Apply liberally/generously (and evenly) 15 minutes before sun exposure;
  • Reapply at least every 2 hours; and
  • For use on children less than 6 months of age, consult a health care practitioner.
For products with a critical wavelength of ≥ 370 nm and SPF ≥ 15:

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m.-2 p.m.; and
  • wear long-sleeved shirts, pants, hats, and sunglasses.
For products that are non-water resistant:

Use a water resistant sunscreen if swimming or sweating.

For products that are water resistant:
  • Reapply after 40 [or 80] minutes of swimming or sweating; and
  • Reapply immediately after towel drying.
For products that are applied to the lips:

Reapply after eating or drinking.

For spray products15
  • Spray liberally/generously and spread evenly by hand 15 minutes before sun exposure16
  • Hold container 4 to 6 inches from the skin to apply;
  • Do not spray directly onto face. Spray on hands then apply to face;
  • Do not apply in windy conditions;
  • Use in a well-ventilated area; and
  • Avoid inhaling or exposing others to spray.

Duration(s) of Use

No statement is required.

Risk information17

Cautions and Warning(s)

Statement(s) to the effect of

For all products:

  • For external use only;
  • Do not use on damaged or broken skin;
  • If rash occurs, discontinue use and consult a health care practitioner;
  • When using this product keep out of eyes. Rinse with water to remove; and
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
For products without a critical wavelength of ≥ 370 nm or with SPF value of < 15:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Contraindication(s)

No statement required.

Known Adverse Reaction(s)

No statement required.

Non-medicinal ingredients

Ingredients must be chosen from the current Natural Health Products Ingredients Database18 and must meet the limitations outlined in that database, the Food and Drugs Regulations (FDR)19, the Herbs used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use20, and/or the current Cosmetic Ingredient Hotlist21, when relevant.

Specifications

For all products:

The requirements described in the FDR or the Natural Health Products Regulations22, as applicable, must be met.

When applicable, the medicinal ingredient(s) should comply with the specifications outlined in the associated monograph from the standards listed on Schedule B to the Food and Drugs Act23.

For products containing medicinal ingredients from Table 1 only:

The finished product must comply with the minimum specifications outlined in the NHPD Quality of Natural Health Products Guide24.

For products containing one or more medicinal ingredients listed in Table 2:

Where no Schedule B monograph exists for the finished product's dosage form, specifications should be similar to those of a comparable compendial dosage form demonstrating the product's identity, potency, purity and quality.

Sunscreen products that contain medicinal ingredients not included in Table 2 may be considered New Drugs as per section C.08.001of the FDR.

Table 3 Footnotes

Table 3 Footnote 8

US FDA 2012

Return to Table 3 footnote8 referrer

Table 3 Footnote 9

Consult Appendices 1 and 2 for unacceptable use(s) or purpose(s) and additional optional use(s) or purpose(s), respectively.

Return to Table 3 footnote9 referrer

Table 3 Footnote 10

As determined using a standardized and reproducible method, such as the one referenced in US FDA 2012 or as ISO 2010.

Return to Table 3 footnote10 referrer

Table 3 Footnote 11

The SPF value must be ≥ 2 and values greater than 50 are to be declared as SPF 50+.

Return to Table 3 footnote11 referrer

Table 3 Footnote 12

As determined using a standardized and reproducible method, such as the one referenced in US FDA 2012 or as ISO 2012 and Colipa 2011

Return to Table 3 footnote12 referrer

Table 3 Footnote 13

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).

Return to Table 3 footnote13 referrer

Table 3 Footnote 14

Diffey 2001; US FDA 1999, 2006 and 2007

Return to Table 3 footnote14 referrer

Table 3 Footnote 15

US FDA 2011a; US FDA 2011b

Return to Table 3 footnote15 referrer

Table 3 Footnote 16

Replaces the statement "Apply liberally/generously (and evenly) 15 minutes before sun exposure" indicated for all products.

Return to Table 3 footnote16 referrer

Table 3 Footnote 17

US FDA 2012

Return to Table 3 footnote17 referrer

Table 3 Footnote 18

Health Canada 2013

Return to Table 3 footnote18 referrer

Table 3 Footnote 19

Government of Canada 2013a

Return to Table 3 footnote19 referrer

Table 3 Footnote 20

Health Canada 1995

Return to Table 3 footnote20 referrer

Table 3 Footnote 21

Health Canada 2011a

Return to Table 3 footnote21 referrer

Table 3 Footnote 22

Government of Canada 2013b

Return to Table 3 footnote22 referrer

Table 3 Footnote 23

Government of Canada 2013c

Return to Table 3 footnote23 referrer

Table 3 Footnote 24

Health Canada 2012

Return to Table 3 footnote24 referrer

Table 3 Footnote 25

Sunless tanners containing skin dyes (for example, dehydroxyacetone) are permitted.

Return to Table 3 footnote25 referrer

Table 3 Footnote 26

All iterations of the acceptable indications are referenced to Shaath 2005; APhA 2002.

Return to Table 3 footnote26 referrer

Table 3 Footnote 27

As determined using a standardized and reproducible method, such as the one referenced as ISO 2012, Colipa 2011, or ISO 2011.

Return to Table 3 footnote27 referrer

Table 3 Footnote 28

Health Canada 2006

Return to Table 3 footnote28 referrer

References cited

References reviewed

  • Beasley D.G., Meyer T.A. 2010. Characterization of the UVA protection provided by avobenzone, zinc oxide, and titanium dioxide in broad-spectrum sunscreen products. American Journal of Clinical Dermatology 11(6):413-421.
  • Canadian Cancer Society 2013. Next link will take you to another Web site Sun and UV. Accessed 2013-05-15].
  • Canadian Dermatology Association 2013. Next link will take you to another Web site Sun Safety. [Accessed 2013-05-16].
  • Colipa 2006. Cosmetics Europe: the Personal Care Association. Next link will take you to another Web site International Sun Protection Factor (SPF) Test Method. [Accessed 2013-05-15].
  • Couteau C., Chammas R., Alami-El Boury S., Choquenet B., Paparis E., Coiffard L.J. 2008 Combination of UVA-filters and UVB-filters or inorganic UV filters-Influence on the sun protection factor (SPF) and the PF-UVA determined by in vitro method. Journal of Dermatological Science 50(2):159-161.
  • Diffey B.L. 2001. When should sunscreen be reapplied? Journal of the American Academy of Dermatology 45(6):882-885.
  • El-Boury S., Couteau C., Boulande L., Paparis E., Coiffard L.J.M. 2007. Effect of the combination of organic and inorganic filters on the Sun Protection Factor (SPF) determined by in vitro method. International Journal of Pharmaceutics 340:1-5.
  • European Union 2006. Commission recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto. Official Journal of the European Union L 265/39.
  • International Agency for Research on Cancer. IARC Handbooks of Cancer Prevention: Sunscreens (Volume 5). World Health Organization, Lyon 2001.
  • JCIA 1995. Japan Cosmetic Industry Association Measurement Standard for UVA Protection Efficacy. Next link will take you to another Web site Appendix 3: JCIA/Persistant Pigment Darkening Protocol. [Accessed 2013-05-16].
  • Nash JF, Tanner PR, Matts PJ. Ultraviolet A radiation: testing and labeling for sunscreen products. Dermatologic Clinics 2006; 24:63-74.
  • TGA 2010. Department of Health and Ageing, Therapeutic Goods Administration: Australian Government. Next link will take you to another Web site Proposed Revisions to Chapter 10 'Sunscreens' in the Australian Regulatory Guidelines for OTC Medicines (ARGOM). [Accessed 2013-05-16].
  • US FDA 2011b. Department of Health and Human Services: Food and Drug Administration. Labeling and Effectiveness Testing; Next link will take you to another Web site Sunscreen Drug Products for Over-the-Counter Human Use. 21 CFR Parts 201 and 310 [Docket No. FDA-1978-N-0018] (Formerly Docket No. 1978N-0038) RIN 0910-AF43. Final Rule. Federal Register / Vol. 76, No. 117 / Friday, June 17, 2011 / Rules and Regulations 35620-35665. [Accessed 2013-05-15].
  • US FDA 2007. Department of Health and Human Services: Food and Drug Administration. Next link will take you to another Web site Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph. 21 CFR Parts 347 and 352 [Docket No. 1978N-0038] (formerly Docket No. 78N- 0038) RIN 0910-AF43. Proposed Rule. [Accessed 2013-05-15].
  • US FDA 1993. Department of Health and Human Services: Food and Drug Administration. Next link will take you to another Web site Sunscreen Drug Products for Over-the-Counter Human Use; Tentative Final Monograph. 21 CFR Parts 352, 700, and 740 [Docket No. 78N-0038] RIN 0905-AA06. Notice of proposed rulemaking. [Accessed 2013-05-16].
  • World Health Organization 2013. Next link will take you to another Web site Ultraviolet radiation and the INTERSUN Programme. [Accessed 2013-05-16].

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

  • "Sunblock", "sun shield", or any other term implying that the product either prevents UV ray penetration and/or provides total or complete protection;
  • Provides "X" times your natural protection against sunburn;
  • For sun-sensitive or fair-skinned persons, to prevent sunburn;
  • For skin where exposure to UV light is contraindicated;
  • Increases, perpetuates, or aids in the development of a tan25;
  • Allows you to stay longer in the sun;
  • Waterproof, sweat proof;
  • Representation that use of this product will repair or reverse any skin damage;
  • Products for infants' scalps; and/or
  • A "+" ("plus") indication next to the SPF value, with the exception of SPF 50+.
Unacceptable use(s) or purpose(s) which require assessment of supporting scientific data outside of the Monograph:

Statement(s) to the effect of

  • Sustained-release;
  • Sustained action/long-lasting (i.e. longer than 2 hours or longer than 80 minutes in water);
  • Sunscreens with insect repellents;
  • Representation for the prevention of cancer (only the complete Sun Protection Measures statement may be used);
  • Representation for the prevention of photoaging and/or related damage (i.e. age spots, wrinkles, etc.); and/or
  • Representation that the use of this product alone will prevent or minimize long term damage to the skin or skin cancer;
  • UVC protection claims (or other UV rays apart from UVA/UVB);
  • Claims that the product is photostable or photostabilized; and/or
  • Claims that the product can be applied directly to wet or sweaty skin.

APPENDIX 2: Optional Label-related Information

Additional optional use(s) or purpose(s):

Statement(s) to the effect of26:

  • Sunscreen;
  • Sunburn protectant;
  • Helps protects from sunburn;
For products with a critical wavelength of ≥ 370 nm:
  • Filters/screens UVA/UVB rays; and/or
  • Absorbs throughout the UVA/UVB spectrum to provide sunburn protection.
The following claims may be used on the product label provided that there is scientific product-specific data on file to support the claim:

Statement(s) to the effect of

  • Hypoallergenic;
  • For sensitive skin;
  • Non-comedogenic (won't block pores);
  • Non-acnegenic (will not cause or contribute to acne); and/or
  • Non-irritating.
The following additional information may also be included on labelling:
  • Logos from the Canadian Dermatology Association (CDA) may be used, provided that the license holder obtains a letter from the CDA accepting this representation;
  • Other logos, such as the European Commission UVA logo, as long as all associated requirements for those logos, such as the UVA Protection Factor (UVAPF):SPF ratio ≥ 1:327, are met; and/or
  • Cosmetic claims that meet the requirements outlined in the Guidelines for Cosmetic Advertising and Labelling Claims28.

APPENDIX 3: Labelling Requirements for Secondary Sunscreen Products

Secondary sunscreen products are products that are intended to be applied to the face or skin as makeup or skincare products which carry 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 full labelling requirements apply. Acceptable cosmetic claims can be found in Health Canada's Guidelines for Cosmetic Advertising and Labelling Claims.

Labelling requirements for secondary sunscreen products will be finalized and communicated at a later date.