Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30

Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30
SPL v7
SPL
SPL Set ID f527a8c5-b05e-5f3c-e053-2995a90aa1a3
Route
TOPICAL
Published
Effective Date 2025-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (28.8 mg) Zinc Cation (68 mg)
Inactive Ingredients
Isoamyl Laurate Medium-chain Triglycerides Butyloctyl Salicylate Glycerin Alkyl (c12-15) Benzoate Arachidyl Alcohol Polyglyceryl-10 Laurate Cetearyl Olivate Sorbitan Olivate Argan Oil Fructose Flax Seed Ribes Nigrum Seed Oil Rubus Chamaemorus Seed Oil Withania Somnifera Root Water Sambucus Nigra Seed Oil Glycyrrhizinate Dipotassium Lingonberry Seed Oil Hippophae Rhamnoides Fruit Betula Pubescens Bark Basil Oil .alpha.-tocopherol Acetate Lavender Oil Pelargonium Graveolens Flower Oil Bergamot Oil Orange Oil, Cold Pressed Lemon Oil, Cold Pressed Hydroxyacetophenone Biosaccharide Gum-4 Stearic Acid Levomenol Arachidyl Glucoside Docosanol Cetyl Alcohol Stearyl Alcohol Carboxymethylcellulose Sodium, Unspecified Xanthan Gum 1,2-hexanediol Citric Acid Monohydrate Aluminum Oxide Microcrystalline Cellulose Potassium Sorbate Limonene, (+)- Linalool, (+/-)- Citral

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Titanium Dioxide ............ 2.88% Zinc Oxide........................ 6.80%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide ............ 2.88% Zinc Oxide........................ 6.80%

Uses

Helps prevent sunburn.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 40 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Children under 6 months of age: Ask a doctor.
  • 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.
  • Store in a cool dry place.
  • Do not use if safety seal is broken.
  • May stain some fabric.
  • Protect the product in this container from excessive heat and direct sun.
Do Not Use

on broken skin.

Package Labeling:

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children.

If swallowed, call a poison control centre or get medical help right away.

Non Medicinal/other ingredients:

Water, Isoamyl Laurate, Caprylic/ Capric Triglyceride, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Arachidyl Alcohol, Polyglyceryl-10 Laurate, Cetearyl Olivate, Lactobacillus Ferment, Sorbitan Olivate, Argania Spinosa (Argan) Kernel Oil, Fructose, Linum Usitatissimum (Flaxseed) Seed Oil*, Ribes Nigrum (Black Currant) Seed Oil*, Rubus Chamaemorus (Cloudberry) Seed Oil*, Withania Somnifera (Ashwagandha) Root Extract, Sambucus Nigra (Elderberry) Seed Oil*, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea (Lingonberry) Seed Oil*, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Betula Alba (Birch Sap Juice) Bark Extract, Ocimum Basilicum (Basil) Oil, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Hydroxyacetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Polyhydroxystearic Acid, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, Xanthan Gum, 1,2-Hexanediol, Citric Acid, Alumina, Microcrystalline Cellulose, Styrene/Acrylates Copolymer, Potassium Sorbate, Limonene, Linalool, Citral. *Organic Ingredients/ Ingrédients organiques.

Stop Use and Consult A Doctor if

rash occurs.

Actives/medicinal ingredients:% W/w P/p:

Titanium Dioxide ............ 2.88%

Zinc Oxide........................ 6.80%


Structured Label Content

Uses (USES)

Helps prevent sunburn.

Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

For external use only.

Directions (DIRECTIONS)
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 40 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Children under 6 months of age: Ask a doctor.
  • 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.
  • Store in a cool dry place.
  • Do not use if safety seal is broken.
  • May stain some fabric.
  • Protect the product in this container from excessive heat and direct sun.
Do Not Use (Do not use)

on broken skin.

Package Labeling:

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call a poison control centre or get medical help right away.

Non Medicinal/other ingredients: (NON-MEDICINAL/OTHER INGREDIENTS:)

Water, Isoamyl Laurate, Caprylic/ Capric Triglyceride, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Arachidyl Alcohol, Polyglyceryl-10 Laurate, Cetearyl Olivate, Lactobacillus Ferment, Sorbitan Olivate, Argania Spinosa (Argan) Kernel Oil, Fructose, Linum Usitatissimum (Flaxseed) Seed Oil*, Ribes Nigrum (Black Currant) Seed Oil*, Rubus Chamaemorus (Cloudberry) Seed Oil*, Withania Somnifera (Ashwagandha) Root Extract, Sambucus Nigra (Elderberry) Seed Oil*, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea (Lingonberry) Seed Oil*, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Betula Alba (Birch Sap Juice) Bark Extract, Ocimum Basilicum (Basil) Oil, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Hydroxyacetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Polyhydroxystearic Acid, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, Xanthan Gum, 1,2-Hexanediol, Citric Acid, Alumina, Microcrystalline Cellulose, Styrene/Acrylates Copolymer, Potassium Sorbate, Limonene, Linalool, Citral. *Organic Ingredients/ Ingrédients organiques.

Stop Use and Consult A Doctor if (Stop use and consult a doctor if)

rash occurs.

Actives/medicinal ingredients:% W/w P/p: (ACTIVES/MEDICINAL INGREDIENTS:% W/W- P/P:)

Titanium Dioxide ............ 2.88%

Zinc Oxide........................ 6.80%


Advanced Ingredient Data


Raw Label Data

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