SPL v9
SPL
SPL Set ID b098aba3-dad6-4421-a943-e88ce5e2f8d6
Route
TOPICAL
Published
Effective Date 2024-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (9 g) Zinc Oxide (6.3 g)
Inactive Ingredients
Water Butylene Glycol Phenyl Trimethicone Butylene Glycol Dicaprylate/dicaprate Butyloctyl Salicylate Magnesium Sulfate, Unspecified Form Polyglyceryl-4 Isostearate Aluminum Hydroxide Hexyl Laurate Stearic Acid Calcium Stearate Caprylyl Glycol Triethoxycaprylylsilane Ethylhexylglycerin Sorbitan Isostearate Phenoxyethanol 1,2-hexanediol Magnesium Disodium Edta Lime Oil Grape Seed Oil Punica Granatum Seed Oil Avocado Oil Niacinamide White Pine Oil Grapefruit Oil Cholesterol Glycerin Eucalyptus Oil Green Tea Leaf Soybean Oil Pentafluoropropane Turmeric Steareth-20 Silk, Base Hydrolyzed (1000 Mw) Hyaluronic Acid Oatmeal Citric Acid Monohydrate Sodium Benzoate Potassium Sorbate Aloe Vera Leaf N-hydroxysuccinimide Hydrolysed Marine Collagen (enzymatic; 2000 Mw) Caprylhydroxamic Acid Tocopherol Thiamine Hydrochloride Riboflavin Retinol Pantothenic Acid Palmitoyl Oligopeptide Niacin Folic Acid Chrysin Carnitine Hydrochloride, (+)- Biotin Ascorbic Acid Palmitoyl Tetrapeptide-7 Chlorhexidine Brown Iron Oxide Cholesteryl Oleyl Carbonate Cholesteryl Nonanoate Cholesteryl Isostearate Cholesteryl Chloride

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-23
Description

Titanium dioxide 9.0% Zinc oxide 6.3%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 9.0% Zinc oxide 6.3%

Uses

• Helps prevent sunburn.

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 51945-4

Warnings

For external use only

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hour.

• 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-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months of age: Ask a doctor.

Do Not Use

on damaged or broken skin

Questions?

Call 800.620.3950

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Titanium dioxide 9.0%

Zinc oxide 6.3%

Inactive Ingredients

Water, Snail Secretion Filtrate, Phenyl Trimethicone, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-4 Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Hexyl Laurate, Calcium Stearate, Caprylyl Glycol, Triethoxycaprylylsilane, Ethylhexylglycerin, Citrus Medica Limonum (Lemon) Peel Oil, Tocopheryl Acetate, Sorbitan Isostearate, Phenoxyethanol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Disodium EDTA, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantifolia (Lime) Oil, Cholesterol, Persea Gratissima (Avocado) Oil, Cholesteryl Oleyl Carbonate, Pinus Sylvestris Leaf Oil, Niacinamide, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Lactobacillus/Pumpkin Ferment Extract, Polymethylsilsesquioxane, Anthemis Nobilis Flower Water, Lactobacillus/Dipteryx Odorata Seed Ferment Filtrate, Avena Sativa (Oat) Kernel Extract, Panax Ginseng Root Extract*, Eucalyptus Globulus Leaf Oil, Saccharomyces/Rice Ferment Filtrate, Lactobacillus/Kelp Ferment Filtrate, Cholesteryl Nonanoate, Cholesteryl Isostearate, Cholesteryl Chloride, Curcuma Longa (Turmeric) Root Extract, Lactobacillus/Honeysuckle Flower/Licorice Root/Morus Alba Root/Pueraria Lobata Root/Schizandra Chinensis Fruit/Scutellaria Baicalensis Root/Sophora Japonica Flower Extract Ferment Filtrate, Magnolia Kobus Bark Extract, Glycine Soja (Soybean) Sprout Extract, Perfluorohexane, Glycerin, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hydrolyzed Silk, Perfluorodecalin, Silk Extract, Olea Europaea (Olive) Leaf Extract, Pentafluoropropane, Steareth-20, Citric Acid, Cocos Nucifera (Coconut) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Hydrolyzed Collagen, Lactobacillus/Rice Ferment Filtrate, Lactobacillus/Centella Asiatica/Gleditsia Sinensis Thorn/Houttuynia Cordata Extract/Phellodendron Amurense Bark/Polygonum Cuspidatum Root/Prunella Vulgaris/Torilis Japonica Extract Ferment Filtrate, Lactobacillus Ferment, Bacillus/Cordyceps Sinensis/Ganoderma Lucidum/Inonotus Obliquus/Lentinus Edodes/Phellinus Linteus/Schizophyllum Commune/Tricholoma Matsutake Extract Ferment Filtrate, Phaseolus Angularis Seed Extract, Saccharomyces/Camellia Sinensis Extract Ferment Filtrate, Sodium Benzoate, Potassium Sorbate, Chrysanthemum Indicum Flower Extract, Diamond Powder, Caprylhydroxamic Acid, Artemisia Princeps Leaf Extract, Cinnamomum Cassia Bark Extract, Diospyros Kaki Leaf Extract, Morus Alba Fruit Extract, Aloe Barbadensis Leaf Extract, N-Hydroxysuccinimide, Pantothenic Acid, Biotin, Thiamine HCl, Retinyl Palmitate, Tocopherol, Niacin, Carnitine HCl, Ascorbic Acid, Riboflavin, Folic Acid, Palmitoyl Oligopeptide, Chrysin, Hydrolyzed Hyaluronic Acid, Palmitoyl Tetrapeptide-7, Chlorhexidine digluconate, Iron Oxides (CI 77492, CI 77491, CI 77499).

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact Poison Control Center right away.

Structured Label Content

Uses

• Helps prevent sunburn.

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hour.

• 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-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months of age: Ask a doctor.

Do Not Use (Do not use)

on damaged or broken skin

Questions?

Call 800.620.3950

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Titanium dioxide 9.0%

Zinc oxide 6.3%

Inactive Ingredients (Inactive ingredients)

Water, Snail Secretion Filtrate, Phenyl Trimethicone, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-4 Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Hexyl Laurate, Calcium Stearate, Caprylyl Glycol, Triethoxycaprylylsilane, Ethylhexylglycerin, Citrus Medica Limonum (Lemon) Peel Oil, Tocopheryl Acetate, Sorbitan Isostearate, Phenoxyethanol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Disodium EDTA, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantifolia (Lime) Oil, Cholesterol, Persea Gratissima (Avocado) Oil, Cholesteryl Oleyl Carbonate, Pinus Sylvestris Leaf Oil, Niacinamide, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Lactobacillus/Pumpkin Ferment Extract, Polymethylsilsesquioxane, Anthemis Nobilis Flower Water, Lactobacillus/Dipteryx Odorata Seed Ferment Filtrate, Avena Sativa (Oat) Kernel Extract, Panax Ginseng Root Extract*, Eucalyptus Globulus Leaf Oil, Saccharomyces/Rice Ferment Filtrate, Lactobacillus/Kelp Ferment Filtrate, Cholesteryl Nonanoate, Cholesteryl Isostearate, Cholesteryl Chloride, Curcuma Longa (Turmeric) Root Extract, Lactobacillus/Honeysuckle Flower/Licorice Root/Morus Alba Root/Pueraria Lobata Root/Schizandra Chinensis Fruit/Scutellaria Baicalensis Root/Sophora Japonica Flower Extract Ferment Filtrate, Magnolia Kobus Bark Extract, Glycine Soja (Soybean) Sprout Extract, Perfluorohexane, Glycerin, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hydrolyzed Silk, Perfluorodecalin, Silk Extract, Olea Europaea (Olive) Leaf Extract, Pentafluoropropane, Steareth-20, Citric Acid, Cocos Nucifera (Coconut) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Hydrolyzed Collagen, Lactobacillus/Rice Ferment Filtrate, Lactobacillus/Centella Asiatica/Gleditsia Sinensis Thorn/Houttuynia Cordata Extract/Phellodendron Amurense Bark/Polygonum Cuspidatum Root/Prunella Vulgaris/Torilis Japonica Extract Ferment Filtrate, Lactobacillus Ferment, Bacillus/Cordyceps Sinensis/Ganoderma Lucidum/Inonotus Obliquus/Lentinus Edodes/Phellinus Linteus/Schizophyllum Commune/Tricholoma Matsutake Extract Ferment Filtrate, Phaseolus Angularis Seed Extract, Saccharomyces/Camellia Sinensis Extract Ferment Filtrate, Sodium Benzoate, Potassium Sorbate, Chrysanthemum Indicum Flower Extract, Diamond Powder, Caprylhydroxamic Acid, Artemisia Princeps Leaf Extract, Cinnamomum Cassia Bark Extract, Diospyros Kaki Leaf Extract, Morus Alba Fruit Extract, Aloe Barbadensis Leaf Extract, N-Hydroxysuccinimide, Pantothenic Acid, Biotin, Thiamine HCl, Retinyl Palmitate, Tocopherol, Niacin, Carnitine HCl, Ascorbic Acid, Riboflavin, Folic Acid, Palmitoyl Oligopeptide, Chrysin, Hydrolyzed Hyaluronic Acid, Palmitoyl Tetrapeptide-7, Chlorhexidine digluconate, Iron Oxides (CI 77492, CI 77491, CI 77499).

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

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

If swallowed, get medical help or contact Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:48.381838 · Updated: 2026-03-14T23:11:37.729091