Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1acd3f09-87f2-75e4-e063-6394a90a0cd9
Route
TOPICAL
Published
Effective Date 2024-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (6.5 g) Zinc Oxide (8.6 g)
Inactive Ingredients
Tocopherol Peg/ppg-18/18 Dimethicone Polyglyceryl-4 Isostearate Hexylene Glycol Dimethicone Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Hydroxytyrosol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Palmitoyl Tetrapeptide-7 Ascorbic Acid Lecithin, Soybean Arabica Coffee Bean Sodium Ferrocyanide Decahydrate Polygonum Aviculare Top Sodium Benzoate Alcohol Carbomer Homopolymer, Unspecified Type Cyclomethicone 4 Glycerin Stearic Acid Dipropylene Glycol Cyclotetrapeptide-24 Aminocyclohexane Carboxylate Polysorbate 20 Caprylyl Glycol Hyaluronate Sodium Hexyl Laurate Aluminum Hydroxide Palmitoyl Tripeptide-1 Wine Grape Cetearyl Olivate Alkyl (c12-15) Benzoate Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Dimethicone/peg-10/15 Crosspolymer Apple Polysilicone-15 Polyethylene Glycol 400 Butylene Glycol Cyclomethicone 5 Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Sorbitan Olivate Ascorbyl Palmitate Phenoxyethanol Ethylhexylglycerin Sodium Citrate Dimethicone/polyglycerin-3 Crosspolymer Green Tea Leaf Water Sodium Chloride .alpha.-tocopherol Acetate Benzoic Acid Silica Dimethyl Silylate Pentylene Glycol Citric Acid Monohydrate Ethylhexyl Palmitate Cyclomethicone 6 Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Potassium Sorbate Ectoine Isomalt

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-17
Description

Active Ingredients: Zinc Oxide 8.6%, Titanium Dioxide 6.5%

Medication Information

Warnings and Precautions

Warning: For external use only.

Indications and Usage

Uses: Broad spectrum (Sun Protection Factor 50 /SPF 50).

Dosage and Administration

Directions: Adults and Children over 6 months of age: Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. 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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses

Description

Active Ingredients: Zinc Oxide 8.6%, Titanium Dioxide 6.5%

Section 50565-1

Keep out of reach of Children -if swallowed get medical help or contact Poison Control Center right away.

Section 50566-9

Discontinue use if rash or irritation develops or lasts. If irritation persists, consult a doctor.

Section 50567-7

When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Inactive ingredients: Water (Aqua), Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polysilicone-31, Glycerin, Aluminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Dipropylene Glycol, Sodium Citrate, Tocopherol, Dimethicone/Polyglycerin-3 Crosspolymer, Dimethicone / Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-1011 Dimethicone, Hexyl Laurate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Cetearyl Olivate, Sorbitan Olivate, Benzoic Acid, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Pentylene Glycol, Sodium Hyaluronate, Cyclohexasiloxane, PEG-8, Ascorbyl Palmitate, Ascorbic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Ferrocyanide Deca hydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetra peptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffee Arabica (Coffee) Seed Extract, Citric Acid, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol

Section 51945-4

Section 55105-1

Purpose: Sun Protectant

Section 55106-9

Active Ingredients: Zinc Oxide 8.6%, Titanium Dioxide 6.5%

Section 60561-8

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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses

Structured Label Content

Indications and Usage (34067-9)

Uses: Broad spectrum (Sun Protection Factor 50 /SPF 50).

Dosage and Administration (34068-7)

Directions: Adults and Children over 6 months of age: Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. 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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses

Warnings and Precautions (34071-1)

Warning: For external use only.

Section 50565-1 (50565-1)

Keep out of reach of Children -if swallowed get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

Discontinue use if rash or irritation develops or lasts. If irritation persists, consult a doctor.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

Inactive ingredients: Water (Aqua), Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclotetrasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polysilicone-31, Glycerin, Aluminum Hydroxide, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Dipropylene Glycol, Sodium Citrate, Tocopherol, Dimethicone/Polyglycerin-3 Crosspolymer, Dimethicone / Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate, PEG/PPG-18/18 Dimethicone, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-1011 Dimethicone, Hexyl Laurate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Cetearyl Olivate, Sorbitan Olivate, Benzoic Acid, Ethylhexyl Palmitate, Silica Dimethyl Silylate, Butylene Glycol, Pentylene Glycol, Sodium Hyaluronate, Cyclohexasiloxane, PEG-8, Ascorbyl Palmitate, Ascorbic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Ferrocyanide Deca hydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetra peptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffee Arabica (Coffee) Seed Extract, Citric Acid, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sun Protectant

Section 55106-9 (55106-9)

Active Ingredients: Zinc Oxide 8.6%, Titanium Dioxide 6.5%

Section 60561-8 (60561-8)

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 take other sun protection measures including limiting time in the sun, especially from 10 a.m. - 2 p.m., and wearing long-sleeve shirts, pants, hats and sunglasses

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:09.579300 · Updated: 2026-03-14T23:03:04.544899