Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 19b19023-1340-6609-e063-6394a90a6eaf
Route
TOPICAL
Published
Effective Date 2024-05-09
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
Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Polyethylene Glycol 400 Ascorbyl Palmitate Alcohol Carbomer Homopolymer, Unspecified Type Phenoxyethanol Ethylhexylglycerin Triethoxycaprylylsilane Ferric Oxide Yellow Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Cetearyl Olivate Ethylhexyl Palmitate Hydroxytyrosol Palmitoyl Tripeptide-1 Isomalt Ferrosoferric Oxide Arabica Coffee Bean Stearic Acid Benzoic Acid Pentylene Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Glycerin Hexyl Laurate Polygonum Aviculare Top Ectoine Polyglyceryl-4 Isostearate Hyaluronate Sodium Green Tea Leaf Ferric Oxide Red Cyclomethicone 5 Alkyl (c12-15) Benzoate Silica Dimethyl Silylate Sodium Ferrocyanide Decahydrate Polysorbate 20 Caprylyl Glycol Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Sodium Chloride Dimethicone/polyglycerin-3 Crosspolymer Hexylene Glycol Dimethicone/peg-10/15 Crosspolymer Apple Peg/ppg-18/18 Dimethicone Dipropylene Glycol Tocopherol Citric Acid Monohydrate Palmitoyl Tetrapeptide-7 Wine Grape Sodium Benzoate Lecithin, Soybean Aluminum Hydroxide Sodium Citrate Dimethicone Water Cyclomethicone 4 Cyclomethicone 6 Sorbitan Olivate Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Potassium Sorbate Ascorbic Acid Cyclotetrapeptide-24 Aminocyclohexane Carboxylate .alpha.-tocopherol Acetate Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-09
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-tbutyl 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, Cyclotetrapeptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffea 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-tbutyl 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, Cyclotetrapeptide-24 Aminocyclohexane Carboxylate, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Camellia Sinensis Leaf Extract, Coffea 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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:07.815061 · Updated: 2026-03-14T23:03:01.087200