SPL v1
SPL
SPL Set ID 560fa371-e1a4-4b32-8abd-58439c27aee4
Route
TOPICAL
Published
Effective Date 2016-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.74 g) Octinoxate (0.80 g) Octisalate (0.48 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-08-10

Description

Active Ingredient: Titanium Dioxide 14.5%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

INSTRUCTIONS: A Cushion compact foundation keeps your face looking perfectly just like the start of the day and prevents further darkening of skin. The lightweight, low-viscosity formula helps the foundation adhere to skin instantly while providing excellent coverage just like a liquid foundation.

Directions: Take a small amount with the Ruby Cell Puff and spread evenly over face Please make sure to close the lid after use.

Caution

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

Active Ingredient

Active Ingredient: Titanium Dioxide 14.5%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

Inactive Ingredient

Inactive Ingredients: Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Butylene Glycol, PEG-8 Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Diphenylsiloxy Phenyl Trimethicone, Dipropylene Glycol, Niacinamide, Pentylene Glycol, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Neopentyl Glycol Diheptanoate, PEG-8, Magnesium Sulfate, Synthetic Fluorphlogopite, Dimethicone, SorbitanIsostearate, Phenoxyethanol, DimethiconeCrosspolymer, DisteardimoniumHectorite, Stearic Acid, Alumina, Aluminum Hydroxide, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Fragrance(Parfum), Iron Oxides (CI 77499), Hydrogenated Castor Oil Isostearate, Ethylhexylglycerin, Adenosine, Disodium EDTA, Methyl Methacrylate Crosspolymer, Hydrolyzed Hyaluronic Acid, AnastaticaHierochuntica Extract, Alcohol, AchilleaMillefolium Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, GentianaLutea Root Extract, Lactobacillus Ferment, Potassium Sorbate

Package Label.principal Display Panel


Structured Label Content

Caution (CAUTION)

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

Purpose (PURPOSE)

Purpose: Sunscreen

Description (DESCRIPTION)

INSTRUCTIONS: A Cushion compact foundation keeps your face looking perfectly just like the start of the day and prevents further darkening of skin. The lightweight, low-viscosity formula helps the foundation adhere to skin instantly while providing excellent coverage just like a liquid foundation.

Directions: Take a small amount with the Ruby Cell Puff and spread evenly over face Please make sure to close the lid after use.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient: Titanium Dioxide 14.5%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Butylene Glycol, PEG-8 Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Diphenylsiloxy Phenyl Trimethicone, Dipropylene Glycol, Niacinamide, Pentylene Glycol, Iron Oxides (CI 77492), C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Neopentyl Glycol Diheptanoate, PEG-8, Magnesium Sulfate, Synthetic Fluorphlogopite, Dimethicone, SorbitanIsostearate, Phenoxyethanol, DimethiconeCrosspolymer, DisteardimoniumHectorite, Stearic Acid, Alumina, Aluminum Hydroxide, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Fragrance(Parfum), Iron Oxides (CI 77499), Hydrogenated Castor Oil Isostearate, Ethylhexylglycerin, Adenosine, Disodium EDTA, Methyl Methacrylate Crosspolymer, Hydrolyzed Hyaluronic Acid, AnastaticaHierochuntica Extract, Alcohol, AchilleaMillefolium Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, GentianaLutea Root Extract, Lactobacillus Ferment, Potassium Sorbate

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


Advanced Ingredient Data


Raw Label Data

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