SPL v1
SPL
SPL Set ID b47a3176-066e-4b5f-b21d-9866b0c02018
Route
TOPICAL
Published
Effective Date 2017-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.64 g) Octinoxate (0.80 g) Octisalate (0.48 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-01

Description

Active ingredients: Titanium Dioxide 13.7%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

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.

Directions: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. 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.

Warnings

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

Active Ingredient

Active ingredients: Titanium Dioxide 13.7%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

Inactive Ingredient

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, PEG-8 Dimethicone, Glycerin, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Caprylyl Methicone, Trimethylsiloxysilicate, Pentylene Glycol, Iron Oxides (CI 77492), Rosa Canina Fruit Oil, Tremella Fuciformis (Mushroom) Extract, Hydrolyzed Pearl, Honey Extract, Actinidia Polygama Fruit Extract, Dimethicone, Magnesium Sulfate, Diphenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Stearic Acid, Synthetic Fluorphlogopite, Alumina, Dimethicone Crosspolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Adenosine, Hydrogenated Castor Oil Isostearate, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Polyglutamic Acid, Ethyl Hexanediol, Ceramide 3, Polysorbate 20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Carbomer, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

Description (DESCRIPTION)

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.

Directions: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. 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.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 13.7%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, PEG-8 Dimethicone, Glycerin, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Caprylyl Methicone, Trimethylsiloxysilicate, Pentylene Glycol, Iron Oxides (CI 77492), Rosa Canina Fruit Oil, Tremella Fuciformis (Mushroom) Extract, Hydrolyzed Pearl, Honey Extract, Actinidia Polygama Fruit Extract, Dimethicone, Magnesium Sulfate, Diphenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Stearic Acid, Synthetic Fluorphlogopite, Alumina, Dimethicone Crosspolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Adenosine, Hydrogenated Castor Oil Isostearate, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Polyglutamic Acid, Ethyl Hexanediol, Ceramide 3, Polysorbate 20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Carbomer, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

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


Advanced Ingredient Data


Raw Label Data

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