SPL v1
SPL
SPL Set ID 8fd9dbff-c826-451e-a46f-6446e09aae1d
Route
TOPICAL
Published
Effective Date 2018-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.49 g) Octinoxate (1.05 g) Zinc Cation (0.80 g)
Inactive Ingredients
Water Cyclomethicone 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-09-01

Description

Active ingredients: Titanium Dioxide 9.98%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

Helps prevent sunburn

Directions:

Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.

Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Warnings

Warnings:

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin

- 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

Inactive ingredients:

Water,Cyclopentasiloxane, Glycerin,Phenyl Trimethicone,Butylene Glycol Dicaprylate/Dicaprate

Butylene Glycol,PEG-10 Dimethicone,Caprylyl Methicone,Pentylene Glycol,Niacinamide,Methylene Bis-Benzotriazolyl Tetramethylbutylphenol,Ethylhexyl Palmitate

Trimethylsiloxysilicate,Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate,Boron Nitride,Diphenyl Dimethicone,

Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer,Phytosteryl Isostearyl Dimer Dilinoleate,Biosaccharide Gum-1,Decyl Glucoside

Aluminum Hydroxide,Phenoxyethanol,Methyl Methacrylate Crosspolymer,Disteardimonium Hectorite,Triethoxycaprylylsilane,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Tocopheryl Acetate,Silica Dimethyl Silylate,Ethylhexylglycerin,Allantoin,HDI/Trimethylol Hexyllactone Crosspolymer,Dimethicone/Vinyl Dimethicone Crosspolymer,Adenosine

Disodium EDTA,Propylene Glycol,Xanthan Gum,Pseudoalteromonas Ferment Extract,Aloe Barbadensis Leaf Juice Powder,Silica,Hydrolyzed Extensin,Althaea Rosea Flower Extract

Aloe Barbadensis Leaf Extract,Simmondsia Chinensis (Jojoba) Seed Oil,Argania Spinosa Kernel Oil,Iron Oxides (CI 77492),Iron Oxides (CI 77491),Iron Oxides (CI 77499)

Fragrance,Leontopodium Alpinum Extract,Citric Acid,Sodium Benzoate ,Potassium Sorbate

Active Ingredients 

Active ingredients: Titanium Dioxide 9.98%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

Package Label.principal Display Panel


Structured Label Content

Purpose

Purpose: Sunscreen

Warnings

Warnings:

FOR EXTERNAL USE ONLY

- Do not use on damaged or broken skin

- 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Description (DESCRIPTION)

Uses:

Helps prevent sunburn

Directions:

Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.

Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water,Cyclopentasiloxane, Glycerin,Phenyl Trimethicone,Butylene Glycol Dicaprylate/Dicaprate

Butylene Glycol,PEG-10 Dimethicone,Caprylyl Methicone,Pentylene Glycol,Niacinamide,Methylene Bis-Benzotriazolyl Tetramethylbutylphenol,Ethylhexyl Palmitate

Trimethylsiloxysilicate,Cetyl PEG/PPG-10/1 Dimethicone, Magnesium Sulfate,Boron Nitride,Diphenyl Dimethicone,

Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer,Phytosteryl Isostearyl Dimer Dilinoleate,Biosaccharide Gum-1,Decyl Glucoside

Aluminum Hydroxide,Phenoxyethanol,Methyl Methacrylate Crosspolymer,Disteardimonium Hectorite,Triethoxycaprylylsilane,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Tocopheryl Acetate,Silica Dimethyl Silylate,Ethylhexylglycerin,Allantoin,HDI/Trimethylol Hexyllactone Crosspolymer,Dimethicone/Vinyl Dimethicone Crosspolymer,Adenosine

Disodium EDTA,Propylene Glycol,Xanthan Gum,Pseudoalteromonas Ferment Extract,Aloe Barbadensis Leaf Juice Powder,Silica,Hydrolyzed Extensin,Althaea Rosea Flower Extract

Aloe Barbadensis Leaf Extract,Simmondsia Chinensis (Jojoba) Seed Oil,Argania Spinosa Kernel Oil,Iron Oxides (CI 77492),Iron Oxides (CI 77491),Iron Oxides (CI 77499)

Fragrance,Leontopodium Alpinum Extract,Citric Acid,Sodium Benzoate ,Potassium Sorbate

Active Ingredients 

Active ingredients: Titanium Dioxide 9.98%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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