Sunburn Protectants

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Date: October 12, 2006

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Sunburn protectants are classified as natural health products (NHPs) if they contain ingredients from Table 1. Applicants applying for a natural product number (NPN) can access the appropriate forms and guidance.

Sunburn protectants are classified as drugs if they contain at least one ingredient from Table 2. Applicants applying for a drug identification number (DIN) can access the appropriate forms and templates.

Table 1: NHP medicinal ingredients

Proper name(s)	Common name(s)	Source material(s)	Quantity
Titanium dioxide (Gottschalk and McEwan 2006; USP 29; O'Neil et al. 2001) Titanium oxide (USP 29)	Titanium dioxide (Gottschalk and McEwan 2006; USP 29; O'Neil et al. 2001)	Titanium dioxide* (Gottschalk and McEwan 2006; USP 29; O'Neil et al. 2001) CAS No. 013463-67-7+	≤ 25% (FDA 1999)
Zinc oxide (Gottschalk and McEwan 2006; USP 29; O'Neil et al. 2001)	Zinc oxide (Gottschalk and McEwan 2006; USP 29; O'Neil et al. 2001)	Zinc oxide* (Gottschalk and McEwan 2006; USP 29; O'Neil et al. 2001) CAS No. 001314-13-2+	≤ 25% (FDA 1999)

* Ingredient must be pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Compendium of Monographs) or requires citation of an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.
⁺The CAS number may be provided as additional information.

Table 2: Drug medicinal ingredients

Medicinal ingredient preferred name	Synonyms and other recognized names	Quantity
Avobenzone1	Butyl methoxy dibenzoylmethane	≤ 5%
Cinoxate	2-Ethoxyethyl p-methoxycinnamate	≤ 3%
Diethanolamine-methoxycinnamate		≤ 10 %
Dioxybenzone1	Benzophenone-8	≤ 3%
Drometrizole trisiloxane1		≤ 15%
Ensulizole	2-Phenylbenzimidazole-5-sulfonic acid	≤ 8%
Enzacamene	4-Methylbenzylidene camphor	≤ 6%
Homosalate	Homomenthyl salicylate	≤ 15%
Meradimate1	Menthyl 2-aminobenzoate,menthyl anthranilate	≤ 5%
Octinoxate	2-Ethylhexyl methoxycinnamate, octyl methoxycinnamate	≤ 8.5%
Octisalate	Octyl salicylate2-ethylhexyl salicylate	≤ 6%
Octocrylene	2-Ethylhexyl-2-cyano-3,3 diphenylacrylate	≤ 12%
Oxybenzone1	Benzophenone-3	≤ 6%
Padimate-O	Octyl dimethyl PABA	≤ 8%
Sulisobenzone1	Benzophenone-4	≤ 6%
Terephthalylidene dicamphor sulfonic acid1	3,3'-(1,4-phenylenedimethylidene) bis[7,7-dimethyl-2-oxobicylclo[2.2.1] hept-1-yl methanesulfonic acid	≤ 10%
Triethanolamine salicylate	Trolamine salicylate	≤ 12%

¹ Recognized UVA absorber

Route(s) of administration:

Topical

Dosage form(s):

Those that are suited to the allowable route of administration and are established, scientifically recognized dosage forms.
Aerosols containing chlorofluorocarbons (CFCs) are unacceptable dosage forms.

Use(s) or Purpose(s):

Required use or purpose:

• Sun Protection Factor "X", or SPF "X" (FDA 1999).

Additional use(s) or purpose(s):

Statement(s) to the effect of:

• Sunburn protectant, sunscreen (FDA 1999)
• Helps prevent, or protects, from sunburn (FDA 1999)
• Filters or screens certain of the sun's harmful ultraviolet or UV rays to help prevent sunburn (Shaath 2005; Berardi et al. 2002)
• Gives sunburn protection (FDA 1999)
• UVA/UVB sunburn protection, UVA/UVB protection (Shaath 2005; Berardi et al. 2002; FDA 1993)**
• Broad spectrum UVA/UVB protection, broad spectrum protection against UVA/UVB rays (Shaath 2005; Berardi et al. 2002; FDA 1993)**
• Absorbs throughout the UVA/UVB spectrum to provide sunburn protection (Shaath 2005; Berardi et al. 2002; FDA 1993)**
• Protects against UVA/UVB rays (Shaath 2005; Berardi et al. 2002; FDA 1993). **

Sun alert statement

For products with SPF 15 or higher, the following statement can be used verbatim:

• "The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects. " (Adapted from the Canadian Cancer Society's "Sunsense" Guidelines and The Canadian Dermatology Association's Sun Safety).

Notes regarding Use(s) or Purpose(s):

• It is mandatory to include the SPF on product applications and labels.
• SPFs of up to "60" will be accepted.
• The term "minimal" to qualify the protection will be acceptable for SPF 2 to 12; the term "moderate" for SPF 12 to 30; and the term "high" for SPF 30 to 60 (FDA 1999).
• Use(s) or purpose(s) marked by two asterisks (**) are only permitted if the product contains a Table 1 sunburn protectant ingredient and/or at least one of the UVA absorbers identified in Table 2.
• The sun alert statement may not be broken down, displayed on separate locations on the labelling material and no substitution of words or phrases are permitted. This statement may not include a reference to the name of the product.
• Claims related to "photostability" will be reviewed outside this monograph, as supporting data will need be submitted and reviewed.

Unacceptable Use(s) or Purpose(s):

For all products:

• Sunblock (FDA 1999)
• Provides X times your natural protection against sunburn (FDA 1999).
• For sun-sensitive or fair-skinned persons, to prevent sunburn (FDA 1999).
• For skin where exposure to ultraviolet (or UV) light is contraindicated (FDA 1993)
• The liberal and regular use of this product over the years may help reduce the chance of premature aging of the skin (FDA 1999).
• Increases or aids in the development of a tan.

Dose(s):

Subpopulation: Subpopulation does not need to be specified.

Quantity: See Tables 1 and 2

Permitted combinations: Any combination of the ingredients listed in Table 1 and 2 is permitted. The upper limits for use as a single ingredient also apply when the ingredient is used in combinations (FDA 1999).

Directions for use:

Statement(s) to the effect of:

For primary sunburn protectant products (See Appendix 1 for definition):

• Apply generously prior to sun exposure (Diffey 2001; FDA 1999).
• Reapply as needed or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking (Diffey 2001; FDA 1999)

For secondary sunburn protectant products (See Appendix 1 for definition):

• Apply prior to sun exposure.

For products in "spray (aerosol and non-aerosol) form":

• Do not spray directly onto the face. Spray into hands, and apply to the face.

Duration of use:

No statement is required.

Risk information:

Statement(s) to the effect of:

Cautions and warnings:

For all products:

• Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner (FDA 1999).

For primary sunburn protectant products:

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water (not required on products intended to be applied to the lips) (FDA 1999).
• For external use only (FDA 1999).
• Keep out of reach of children (FDA 1999).
• Consult a health care practitioner prior to use on children less than six months of age (FDA 1999).

For secondary sunburn protectant products:

• Avoid contact with eyes (not required on products intended to be applied to the lips) (FDA 1999).

For all products containing the non-medicinal ingredient(s) alpha-hydroxy acids (AHA) at concentrations ranging from 3-10% and/or retinol at concentrations ranging from 0.1-1.0%:

• "This product contains [insert as appropriate: an alpha-hydroxy acid (AHA) and/or retinol] that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Please limit sun exposure while using this product and for a week afterwards. "

Contraindications:

No statement is required.

Non-medicinal ingredients:

The International Nomenclature for Cosmetic Ingredients (INCI) will be accepted.

For products containing Table 1 medicinal ingredients only:
Ingredients must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.
Other ingredients currently accepted as cosmetic ingredients will also be considered.

Specifications:

This monograph describes those requirements that are specific to this class of drugs and to natural health products (NHPs). Note that requirements described in the Regulations to the Food and Drugs Act must be met.

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 medicinal ingredients only: Products must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.

Special Notes:

1. It is understood that the claimed SPF has been adequately determined by an acceptable method of calculation as outlined in the attached reference (FDA 2005).
2. Any reference to highlight UVA protection, beyond combined UVA and UVB protection against sunburn, is considered inappropriate. A consensus as to the accepted methodology to separately measure the UVA portion of the spectrum and its clinical significance has not yet been determined. A claim for the combined UVA and UVB protection against sunburn is acceptable only for products containing a UVB absorber and a UVA absorber identified in this monograph or for titanium dioxide and zinc oxide.
3. The terms "water resistant," "very water resistant" (the term "waterproof" may be used in place of "very water resistant") are acceptable provided data is available to show that the product meets the testing requirements for these terms outlined in the latest United States Federal Register monograph for sunscreens (FDA 2005).
4. Please see the FDA's Sunscreen Drug Products for Over-the-Counter Human Use Final Monograph (FDA 2005) for SPF Testing Procedures.

References:

Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.

BP 2003: The British Pharmacopoeia Commission. London (UK): Her Majesty's Stationary Office; 2003.

Canadian Cancer Society 2006: Sun Protection: Sunsense Guidelines. [Accessed 2006-04-07]. Available at: http://www.cancer.ca/ccs/internet/standard/0,3182,3172_273070_275853_langId-en,00.html.

Canadian Dermatology Association 2006: Sun Safety. [Accessed 2006-04-07]. Available at: http://www.dermatology.ca/patients_public/info_patients/sun_safety/index.html.

Diffey BL. When should sunscreen be reapplied? Journal of the American Academy of Dermatology. 2001;45(6):882-5

FDA 2005: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Part 352. Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; 2005. [Accessed 2006-01-13]. Available at:
http://www.fda.gov/cder/otcmonographs/Sunscreen/sunscreen(352).pdf.

FDA 1999: USA Department of Health and Human Services: Food and Drug Administration. 21 CFR Parts 310, 352, 700, and 740. Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph; 1999. [Accessed 2006-01-13]. Available at:
http://www.fda.gov/cder/otcmonographs/Sunscreen/sunscreen_FR_19990521.pdf.

FDA 1993: USA Department of Health and Human Services: Food and Drug Administration. 21 FR Part 352. Sunscreen Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; Proposed Rule; 1993. [Accessed 2006-01-13]. Available at:
http://www.fda.gov/cder/otcmonographs/Sunscreen/sunscreen_TF_PR_19930512.pdf.

Gottschalck TE, McEwen GN, editors. International Cosmetic Ingredient Dictionary and Handbook. 11th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2006.

O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th edition. Whitehouse Station (NJ): Merck and Co. , Inc; 2001.

Shaath NA, editor. Sunscreens: Regulations and Commercial Development. 3^rd edition. White Plains (NY): Taylor & Francis Group; 2005.

USP 29: The United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc. ; 2006.

APPENDIX 1: Definitions

Primary sunburn protectant: products that are intended primarily to provide protection against sunburn.

Secondary sunburn protectant: products that are intended to be applied to the face or skin as makeup or skincare products (such as moisturizers) which also contain sunburn protectant components.