SPL v2
SPL
SPL Set ID f1d8a3de-a9cf-4d26-896e-8dff72d0eec1
Route
TOPICAL
Published
Effective Date 2014-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.77 g) Octinoxate (2.25 g) Zinc Cation (0.35 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

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

Description

Active Ingredients: Titanium Dioxide 9.24%, Ethylhexyl Methoxycinnamate 7.5%, Zinc Oxide 1.17%

Purpose

Purpose: UVA/UVB Protection


Medication Information

Purpose

Purpose: UVA/UVB Protection

Description

Active Ingredients: Titanium Dioxide 9.24%, Ethylhexyl Methoxycinnamate 7.5%, Zinc Oxide 1.17%

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: Titanium Dioxide 9.24%, Ethylhexyl Methoxycinnamate 7.5%, Zinc Oxide 1.17%

Inactive Ingredient

Inactive Ingredients:

Water, Cyclopentasiloxane, Butylene Glycol, Ethylhexyl Triazone, Di-C12-13 Alkyl Tartrate, Cetyl Ethylhexanoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, PEG-10 Dimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, 1,2-Hexanediol, Polyglyceryl-4 Isostearate, Hydrated Silica, Sodium Chloride, Magnesium Sulfate, CI 77492, Quaternium-18 Bentonite, Copernicia Cerifera (Carnauba) Wax, Ozokerite, Hydrogen Dimethicone, Aloe Arborescens Leaf Extract, Bisabolol, Beeswax, Aluminum Hydroxide, Dimethicone Crosspolymer, CI 77491, Polyglutamic Acid, Triethoxycaprylylsilane, CI 77499, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Eugenia Caryophyllus (Clove) Flower Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Eucalyptus Globulus Leaf Extract, Citrus Junos Fruit Extract, Sophora Angustifolia Root Extract, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Anthemis Nobilis Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polysorbate 80, Allantoin, Dipotassium Glycyrrhizate, Alcohol, Adenosine, Lecithin, Ubiquinone

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) Using your fingertips, dab it onto any target areas, particularly underneath the eyes. Then slowly begin blending in a circular motion.

Dosage & Administration

Dosage and administration:

Get an appropriate amount of BB cream apply them onto your face and use gentle patting motions to spread and blend it into your skin.

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: Titanium Dioxide 9.24%, Ethylhexyl Methoxycinnamate 7.5%, Zinc Oxide 1.17%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients:

Water, Cyclopentasiloxane, Butylene Glycol, Ethylhexyl Triazone, Di-C12-13 Alkyl Tartrate, Cetyl Ethylhexanoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, PEG-10 Dimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, 1,2-Hexanediol, Polyglyceryl-4 Isostearate, Hydrated Silica, Sodium Chloride, Magnesium Sulfate, CI 77492, Quaternium-18 Bentonite, Copernicia Cerifera (Carnauba) Wax, Ozokerite, Hydrogen Dimethicone, Aloe Arborescens Leaf Extract, Bisabolol, Beeswax, Aluminum Hydroxide, Dimethicone Crosspolymer, CI 77491, Polyglutamic Acid, Triethoxycaprylylsilane, CI 77499, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Eugenia Caryophyllus (Clove) Flower Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Eucalyptus Globulus Leaf Extract, Citrus Junos Fruit Extract, Sophora Angustifolia Root Extract, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Anthemis Nobilis Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Polysorbate 80, Allantoin, Dipotassium Glycyrrhizate, Alcohol, Adenosine, Lecithin, Ubiquinone

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) Using your fingertips, dab it onto any target areas, particularly underneath the eyes. Then slowly begin blending in a circular motion.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Dosage and administration:

Get an appropriate amount of BB cream apply them onto your face and use gentle patting motions to spread and blend it into your skin.

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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