SPL v1
SPL
SPL Set ID 5dc42ab2-cde5-41f5-bb56-0ce9a60fbecb
Route
TOPICAL
Published
Effective Date 2012-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.4 g) Octinoxate (2 g) Octisalate (0.8 g)
Inactive Ingredients
Water Dimethicone Cyclomethicone 5 Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-01-15

Description

Active ingredients: TITANIUM DIOXIDE 6%, ETHYLHEXYL METHOXYCINNAMATE 5%, ETHYLHEXYL SALICYLATE 2%

Indications and Usage

APPLICATION: 1. Apply the cream on your face in five dots to the forehead, nose, two cheeks and chin. 2. Blend the cream evenly throughout the whole face in a gentle patting motion. 3. Leave the cream in for 2-3 minutes until it disappears. 4. Cream will dry into a powdery matte finish and skin will appear dewy with a radiant glow.

Purpose

Purpose: Sunscreen

Dosage and Administration

APPLICATION: 1. Apply the cream on your face in five dots to the forehead, nose, two cheeks and chin. 2. Blend the cream evenly throughout the whole face in a gentle patting motion. 3. Leave the cream in for 2-3 minutes until it disappears. 4. Cream will dry into a powdery matte finish and skin will appear dewy with a radiant glow.


Medication Information

Indications and Usage

APPLICATION:

1. Apply the cream on your face in five dots to the forehead, nose, two cheeks and chin.

2. Blend the cream evenly throughout the whole face in a gentle patting motion.

3. Leave the cream in for 2-3 minutes until it disappears.

4. Cream will dry into a powdery matte finish and skin will appear dewy with a radiant glow.

Purpose

Purpose: Sunscreen

Dosage and Administration

APPLICATION:

1. Apply the cream on your face in five dots to the forehead, nose, two cheeks and chin.

2. Blend the cream evenly throughout the whole face in a gentle patting motion.

3. Leave the cream in for 2-3 minutes until it disappears.

4. Cream will dry into a powdery matte finish and skin will appear dewy with a radiant glow.

Description

Active ingredients: TITANIUM DIOXIDE 6%, ETHYLHEXYL METHOXYCINNAMATE 5%, ETHYLHEXYL SALICYLATE 2%

Warnings

PRECAUTION:

For external use only.

Do not swallow.

Keep out of reach of children.

Avoid contact with eyes.

Do not store it in extreme high or low temperatures

Active Ingredient

Active ingredients: TITANIUM DIOXIDE 6%, ETHYLHEXYL METHOXYCINNAMATE 5%, ETHYLHEXYL SALICYLATE 2%

Inactive Ingredient

Inactive ingredients:

Water, Dimethicone, Cyclopentasiloxane, Mica, Dipropylene Glycol, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Vinyl Dimethicone/ Methicone Silsesquioxane Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, PEG-10 Dimethicone, PEG-9 PolydimethylSiloxyethyl Dimethicone, 4-Methylbenzylidene Camphor, Dimethicone/PEG-10/15 Crosspolymer, Benzophenone-3, Silica, Talc, Sorbitan Olivate, Sodium Chloride, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Silica dimethyl silylate, Sodium Citrate, Methylparaben, Centella Asiatica Extract, Tocopheryl Acetate, Propylparaben, Butylene Glycol, Sodium Hyaluronate, Arbutin, Adenosine, Human Oligopeptide-1, Ultramarines, Fragrance

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label. Principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

PRECAUTION:

For external use only.

Do not swallow.

Keep out of reach of children.

Avoid contact with eyes.

Do not store it in extreme high or low temperatures

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: TITANIUM DIOXIDE 6%, ETHYLHEXYL METHOXYCINNAMATE 5%, ETHYLHEXYL SALICYLATE 2%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Water, Dimethicone, Cyclopentasiloxane, Mica, Dipropylene Glycol, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Vinyl Dimethicone/ Methicone Silsesquioxane Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, PEG-10 Dimethicone, PEG-9 PolydimethylSiloxyethyl Dimethicone, 4-Methylbenzylidene Camphor, Dimethicone/PEG-10/15 Crosspolymer, Benzophenone-3, Silica, Talc, Sorbitan Olivate, Sodium Chloride, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Silica dimethyl silylate, Sodium Citrate, Methylparaben, Centella Asiatica Extract, Tocopheryl Acetate, Propylparaben, Butylene Glycol, Sodium Hyaluronate, Arbutin, Adenosine, Human Oligopeptide-1, Ultramarines, Fragrance

Indications and Usage (INDICATIONS AND USAGE)

APPLICATION:

1. Apply the cream on your face in five dots to the forehead, nose, two cheeks and chin.

2. Blend the cream evenly throughout the whole face in a gentle patting motion.

3. Leave the cream in for 2-3 minutes until it disappears.

4. Cream will dry into a powdery matte finish and skin will appear dewy with a radiant glow.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

APPLICATION:

1. Apply the cream on your face in five dots to the forehead, nose, two cheeks and chin.

2. Blend the cream evenly throughout the whole face in a gentle patting motion.

3. Leave the cream in for 2-3 minutes until it disappears.

4. Cream will dry into a powdery matte finish and skin will appear dewy with a radiant glow.

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

KEEP OUT OF REACH OF CHILDREN

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


Advanced Ingredient Data


Raw Label Data

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