SPL v7
SPL
SPL Set ID 7da16dd7-c26c-4c4e-905f-3bbb878022cc
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

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-09
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

Butylene Glycol, Phenyl Trimethicone, Dimethicone, Snail Secretion Filtrate, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Polyglyceryl-4 Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Hexyl Laurate, Stearic Acid, Calcium Stearate, Caprylyl Glycol, Triethoxycaprylylsilane, Ethylhexylglycerin, Phenoxyethanol, Citrus Medica Limonum (Lemon) Peel Oil, Tocopheryl Acetate, Sorbitan Isostearate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Water, Disodium EDTA, Citrus aurantium dulcis (orange) peel essential oil, Citrus Aurantifolia (Lime) Essential Oil, Vitis Vinifera (Grape) Seed Oil, Punica Granatum Seed Oil, Pinus Sylvestris Leaf Essential Oil, Persea Gratissima (Avocado) Oil, Niacinamide, Citrus Grandis (Grapefruit) Peel Oil, Anthemis Nobilis Flower Water, Lactobacillus/Honeysuckle Flower/Licorice Root/Morus Alba Root/Pueraria Lobata Root/Schizandra Chinensis Fruit/Scutellaria Baicalensis Root/Sophora Japonica Flower Extract Ferment Filtrate, Perfluorohexane, Olea Europaea (Olive) Leaf Extract, Glycerin, Eucalyptus Essential Oil, Cholesterol, Camellia Sinensis Leaf Extract, Chrysanthemum Indicum flower Extract, Pueraria Lobata Root Extract, Perfluorodecalin, Morus Alba Fruit Extract, Magnolia Kobus Bark Extract, Glycine Soja (Soybean) Sprout Extract, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf Extract, Pentafluoropropane, Curcuma Longa (Turmeric) Root Extract, Steareth-20, Hydrolyzed Hyaluronic Acid, Colloidal Oatmeal, Hydrolyzed Silk, Citric Acid, Sodium Benzoate, Potassium sorbate, Aloe Barbadensis Leaf Extract, N-Hydroxysuccinimide, Hydrolyzed Collagen, Caprylhydroxamic Acid, Tocopherol, Thiamine HCl, Riboflavin, Retinyl Palmitate, Pantothenic Acid, Palmitoyl Oligopeptide, Niacin, Folic Acid, Chrysin, Carnitine HCl, Biotin, Ascorbic 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)

Butylene Glycol, Phenyl Trimethicone, Dimethicone, Snail Secretion Filtrate, Butylene Glycol Dicaprylate/Dicaprate, Orbignya Oleifera Seed Oil, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Magnesium Sulfate, Polyglyceryl-4 Isostearate, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Hexyl Laurate, Stearic Acid, Calcium Stearate, Caprylyl Glycol, Triethoxycaprylylsilane, Ethylhexylglycerin, Phenoxyethanol, Citrus Medica Limonum (Lemon) Peel Oil, Tocopheryl Acetate, Sorbitan Isostearate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, 1,2-Hexanediol, Water, Disodium EDTA, Citrus aurantium dulcis (orange) peel essential oil, Citrus Aurantifolia (Lime) Essential Oil, Vitis Vinifera (Grape) Seed Oil, Punica Granatum Seed Oil, Pinus Sylvestris Leaf Essential Oil, Persea Gratissima (Avocado) Oil, Niacinamide, Citrus Grandis (Grapefruit) Peel Oil, Anthemis Nobilis Flower Water, Lactobacillus/Honeysuckle Flower/Licorice Root/Morus Alba Root/Pueraria Lobata Root/Schizandra Chinensis Fruit/Scutellaria Baicalensis Root/Sophora Japonica Flower Extract Ferment Filtrate, Perfluorohexane, Olea Europaea (Olive) Leaf Extract, Glycerin, Eucalyptus Essential Oil, Cholesterol, Camellia Sinensis Leaf Extract, Chrysanthemum Indicum flower Extract, Pueraria Lobata Root Extract, Perfluorodecalin, Morus Alba Fruit Extract, Magnolia Kobus Bark Extract, Glycine Soja (Soybean) Sprout Extract, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf Extract, Pentafluoropropane, Curcuma Longa (Turmeric) Root Extract, Steareth-20, Hydrolyzed Hyaluronic Acid, Colloidal Oatmeal, Hydrolyzed Silk, Citric Acid, Sodium Benzoate, Potassium sorbate, Aloe Barbadensis Leaf Extract, N-Hydroxysuccinimide, Hydrolyzed Collagen, Caprylhydroxamic Acid, Tocopherol, Thiamine HCl, Riboflavin, Retinyl Palmitate, Pantothenic Acid, Palmitoyl Oligopeptide, Niacin, Folic Acid, Chrysin, Carnitine HCl, Biotin, Ascorbic 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: 2026-02-15T12:07:49.840730 · Updated: 2026-03-14T23:11:42.520832