cebbb3b5-4a68-4fbb-a12e-4e46a04c82dd

SPL v2
SPL
SPL Set ID cebbb3b5-4a68-4fbb-a12e-4e46a04c82dd
Route
topical
Published
Effective Date 2017-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (8.82 g)
Inactive Ingredients
water medium-chain triglycerides polyhydroxystearic acid (2300 mw) isostearic acid cetyl alcohol stearyl alcohol polysorbate 60 glycerin grape seed oil jojoba oil sesame oil almond oil phenoxyethanol caprylyl glycol borage seed oil cannabis sativa seed oil evening primrose oil hippophae rhamnoides seed oil shea butter menthol xanthan gum citrus sinensis seed oil patchouli oil evernia prunastri bergamot oil cedrus deodara wood oil tocopherol candelilla wax aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2017-03-01
Description

Zinc Oxide 9.8%

Medication Information

Warnings and Precautions

​For external use only

Active Ingredient

Zinc Oxide 9.8%

Indications and Usage
  • Helps prevent sunscreen
Dosage and Administration
  • apply liberally and evenly 15 minutes before sun exposure
  • apply to all skin exposed to sun
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • ​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.

         ○ wear long-sleeve shirts, pants, hats, and sunglasses

  • children under 6 months of age: Ask a doctor
Description

STOÜT FACE CARE INC.

Suite 19130-2302 West 4th Ave.

Vancouver, BC V6K 4R8

1-888-315-1181

www.stoutfacecare.com

Section 44425-7
  • protect this product from excessive heat and direct sun
Section 50565-1

​Keep out of reach of children​.  If swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9

​Stop use and ask a doctor if ​rash or irritation develops and lasts.

Section 50567-7

​When using this product​ keep out of eyes.  Rinse with water to remove.

Section 50570-1

​Do not use​ on damaged or broken skin.

Section 51727-6

Purified water (eau), Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Emulsifying Wax (Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60), Glycerin, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Phenoxyethanol, Caprylyl Glycol, Borago Officinalis Seed Oil, Cannabis Sativa Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Hippophae Rhamnoides Seed Oil, Butyrospermum Parkii (Shea) Butter, Menthol, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Peel Oil, Pogostemon Cablin Oil, Evernia Prunastri (Oakmoss) Extract, Citus Aurantium Bergamie (Bergamot Fruit) Oil, Cedrus Deodara Wood Oil, Tocopherol, Euphorbia Cerifera (Candelilla) Wax, Aloe Barbadensis Leaf Powder

Section 51945-4

Sto​üt

Daily SPF for Men

SUNSCREEN

Broad spectrum SPF 15

3.04 fl oz (90mL)

Section 55105-1

Zinc Oxide 9.8%............................Sunscreen

Structured Label Content

Warnings and Precautions (34071-1)

​For external use only

Active Ingredient (55106-9)

Zinc Oxide 9.8%

Indications and Usage (34067-9)
  • Helps prevent sunscreen
Dosage and Administration (34068-7)
  • apply liberally and evenly 15 minutes before sun exposure
  • apply to all skin exposed to sun
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • ​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.

         ○ wear long-sleeve shirts, pants, hats, and sunglasses

  • children under 6 months of age: Ask a doctor
Description (34089-3)

STOÜT FACE CARE INC.

Suite 19130-2302 West 4th Ave.

Vancouver, BC V6K 4R8

1-888-315-1181

www.stoutfacecare.com

Section 44425-7 (44425-7)
  • protect this product from excessive heat and direct sun
Section 50565-1 (50565-1)

​Keep out of reach of children​.  If swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

​Stop use and ask a doctor if ​rash or irritation develops and lasts.

Section 50567-7 (50567-7)

​When using this product​ keep out of eyes.  Rinse with water to remove.

Section 50570-1 (50570-1)

​Do not use​ on damaged or broken skin.

Section 51727-6 (51727-6)

Purified water (eau), Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Emulsifying Wax (Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60), Glycerin, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Phenoxyethanol, Caprylyl Glycol, Borago Officinalis Seed Oil, Cannabis Sativa Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Hippophae Rhamnoides Seed Oil, Butyrospermum Parkii (Shea) Butter, Menthol, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Peel Oil, Pogostemon Cablin Oil, Evernia Prunastri (Oakmoss) Extract, Citus Aurantium Bergamie (Bergamot Fruit) Oil, Cedrus Deodara Wood Oil, Tocopherol, Euphorbia Cerifera (Candelilla) Wax, Aloe Barbadensis Leaf Powder

Section 51945-4 (51945-4)

Sto​üt

Daily SPF for Men

SUNSCREEN

Broad spectrum SPF 15

3.04 fl oz (90mL)

Section 55105-1 (55105-1)

Zinc Oxide 9.8%............................Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:16.607048 · Updated: 2026-03-14T22:54:39.402137