Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 181e3f34-c5b2-0976-e063-6394a90a9a78
Route
TOPICAL
Published
Effective Date 2024-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-10
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-10/1 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 Decahydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-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, Triethoxycaprylylsilane, Iron Oxides(CI 77491, CI 77492, CI 77499)

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-10/1 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 Decahydrate, Hydroxytyrosol, Polygonum Aviculare Extract, Sodium Benzoate, Potassium Sorbate, Alcohol, Lecithin, Ectoin, Cyclotetra peptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-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, Triethoxycaprylylsilane, Iron Oxides(CI 77491, CI 77492, CI 77499)

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: 2026-02-15T12:03:04.885209 · Updated: 2026-03-14T23:02:55.861635