SPL v2
SPL
SPL Set ID 329918f2-5d77-494b-975d-597bbaab43e3
Route
TOPICAL
Published
Effective Date 2014-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4.5 g) Octisalate (3 g) Titanium Dioxide (1.8 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-04-01

Description

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%, ETHYLHEXYL SALICYLATE 5.0%, TITANIUM DIOXIDE 3.0%

Purpose

Purpose: UVA/UVB Protection


Medication Information

Purpose

Purpose: UVA/UVB Protection

Description

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%, ETHYLHEXYL SALICYLATE 5.0%, TITANIUM DIOXIDE 3.0%

Warnings

Warnings:

1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :

1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.

2. Do not apply the product to wounds or skin with dermatitis such as eczema.

3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.

4. It contains AHA. If it is your first time to use this product, take a small amount and gently apply to the skin to check if it cause andy trouble to your skin.

Active Ingredient

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%, ETHYLHEXYL SALICYLATE 5.0%, TITANIUM DIOXIDE 3.0%

Inactive Ingredient

Inactive Ingredients:

Water, Cyclopentasiloxane, Isohexadecane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Glycerin, Polysorbate 60, C12-15 Alkyl Benzoate, Dimethicone, Glyceryl Stearate, Dimethicone Crosspolymer, Sorbitan Stearate, Stearic Acid, VP/Eicosene Copolymer, PEG-100 Stearate, Cetearyl Alcohol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 80, PEG-10 Dimethicone, Hexyl Laurate, Panthenol, Caprylyl glycol, Fragrance, Ethylhexylglycerin, Tropolone, Tocopheryl Acetate, Alumina, Magnesium Aluminum Silicate, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Arnica Montana Flower Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Artemisia Absinthium Extract, Xanthan Gum, Disodium EDTA, Sodium Hyaluronate, Ethyl Ascorbyl Ether, Human Oligopeptide-1, Oligopeptide-3

Indications & Usage

Indication and usage:

1) Tighten the lid after using it.

2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

3) Use it on the day you will be in the sun, 30 minutes before you go outside, apply an ounce of sunscreen.

Dosage & Administration

Dosage and administration:

To apply sunscreen, squeeze a dollop of sun cream onto your hand and rub it all the skin that will be exposed to UV.

Keep Out of Reach of Children

Keep out of reach of babies and children.

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: UVA/UVB Protection

Warnings (WARNINGS)

Warnings:

1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :

1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.

2. Do not apply the product to wounds or skin with dermatitis such as eczema.

3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.

4. It contains AHA. If it is your first time to use this product, take a small amount and gently apply to the skin to check if it cause andy trouble to your skin.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 7.5%, ETHYLHEXYL SALICYLATE 5.0%, TITANIUM DIOXIDE 3.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water, Cyclopentasiloxane, Isohexadecane, Butylene Glycol, Isoamyl p-Methoxycinnamate, Glycerin, Polysorbate 60, C12-15 Alkyl Benzoate, Dimethicone, Glyceryl Stearate, Dimethicone Crosspolymer, Sorbitan Stearate, Stearic Acid, VP/Eicosene Copolymer, PEG-100 Stearate, Cetearyl Alcohol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 80, PEG-10 Dimethicone, Hexyl Laurate, Panthenol, Caprylyl glycol, Fragrance, Ethylhexylglycerin, Tropolone, Tocopheryl Acetate, Alumina, Magnesium Aluminum Silicate, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Arnica Montana Flower Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Artemisia Absinthium Extract, Xanthan Gum, Disodium EDTA, Sodium Hyaluronate, Ethyl Ascorbyl Ether, Human Oligopeptide-1, Oligopeptide-3

Indications & Usage (INDICATIONS & USAGE)

Indication and usage:

1) Tighten the lid after using it.

2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

3) Use it on the day you will be in the sun, 30 minutes before you go outside, apply an ounce of sunscreen.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage and administration:

To apply sunscreen, squeeze a dollop of sun cream onto your hand and rub it all the skin that will be exposed to UV.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of babies and children.

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


Advanced Ingredient Data


Raw Label Data

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