SPL v1
SPL
SPL Set ID f3639613-e8be-4ac2-a751-5d767668d115
Route
TOPICAL
Published
Effective Date 2018-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.08 g) Titanium Dioxide (0.84 g) Octisalate (0.46 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-02-01

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.47%, Ethylhexyl Salicylate 3.00%

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 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

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: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.47%, Ethylhexyl Salicylate 3.00%

Inactive Ingredient

Inactive ingredients:

Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Squalane, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Dicaprylyl Carbonate, Dimethicone, Niacinamide, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Triceteareth-4 Phosphate, Glycol Stearate, Phenoxyethanol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, PEG-2 Stearate, Polysorbate 60, Potassium Cetyl Phosphate, Iron Oxides (CI 77492), PEG-10 Dimethicone, Carbomer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminum Hydroxide, Tromethamine, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Fragrance(Parfum), Ethylhexylglycerin, Polysorbate 80, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Sorbitan Oleate, Madecassoside, Asiaticoside, Asiatic Acid, Madecassic Acid, Centella Asiatica Leaf Extract

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 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

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 5.47%, Ethylhexyl Salicylate 3.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Squalane, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Dicaprylyl Carbonate, Dimethicone, Niacinamide, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Triceteareth-4 Phosphate, Glycol Stearate, Phenoxyethanol, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, PEG-2 Stearate, Polysorbate 60, Potassium Cetyl Phosphate, Iron Oxides (CI 77492), PEG-10 Dimethicone, Carbomer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminum Hydroxide, Tromethamine, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Fragrance(Parfum), Ethylhexylglycerin, Polysorbate 80, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Sorbitan Oleate, Madecassoside, Asiaticoside, Asiatic Acid, Madecassic Acid, Centella Asiatica Leaf Extract

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


Advanced Ingredient Data


Raw Label Data

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