SPL v2
SPL
SPL Set ID e0b232cf-b526-4732-a358-6d9e826ec7b4
Route
TOPICAL
Published
Effective Date 2014-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.25 g) Octisalate
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

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

Description

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 5.0%, ETHYLHEXYL SALICYLATE 5.0%

Purpose

Purpose: UVA/UVB Protection


Medication Information

Purpose

Purpose: UVA/UVB Protection

Description

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 5.0%, ETHYLHEXYL SALICYLATE 5.0%

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 5.0%, ETHYLHEXYL SALICYLATE 5.0%

Inactive Ingredient

Inactive Ingredients:

Water, Butylene Glycol, Cyclopentasiloxane, Isoamyl p-Methoxycinnamate, Titanium Dioxide, Polysorbate 60, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Stearic Acid, Hexyl Laurate, Sorbitan Stearate, VP/Eicosene Copolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Isohexadecane, Caprylyl glycol, Ethylhexylglycerin, Panthenol, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (Olive) Fruit Oil, Polysorbate 80, Xanthan Gum, Glycine Soja (Soybean) Sterois, Magnesium Aluminium Silicate, Tropolone, Leuconostoc/Radish Root Ferment Filtrate, Disodium EDTA, Polyglutamic Acid, Centellia Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Offcinalis (Rosemary) Leaf Extract, 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 on 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 5.0%, ETHYLHEXYL SALICYLATE 5.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water, Butylene Glycol, Cyclopentasiloxane, Isoamyl p-Methoxycinnamate, Titanium Dioxide, Polysorbate 60, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Stearic Acid, Hexyl Laurate, Sorbitan Stearate, VP/Eicosene Copolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Alumina, Potassium Cetyl Phosphate, Dimethicone Crosspolymer, Isohexadecane, Caprylyl glycol, Ethylhexylglycerin, Panthenol, Persea Gratissima (Avocado) Oil, Phytosterols, Olea Europaea (Olive) Fruit Oil, Polysorbate 80, Xanthan Gum, Glycine Soja (Soybean) Sterois, Magnesium Aluminium Silicate, Tropolone, Leuconostoc/Radish Root Ferment Filtrate, Disodium EDTA, Polyglutamic Acid, Centellia Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Offcinalis (Rosemary) Leaf Extract, 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 on 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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