3CE FITTING CUSHION FOUNDATION 001- titanium dioxide, octinoxate, octisalate powder

3CE Fitting Cushion Foundation 001 by

Drug Labeling and Warnings

3CE Fitting Cushion Foundation 001 by is a Otc medication manufactured, distributed, or labeled by Nanda Co., Ltd, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 14.1%, 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

PURPOSE

Purpose: Sunscreen

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3CE FITTING CUSHION FOUNDATION 001 
titanium dioxide, octinoxate, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.69 g  in 12 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.80 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.48 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-131-02	2 in 1 CARTON	08/10/2016
1	NDC: 60764-131-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/10/2016

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
Nanda Co., Ltd		557816075	repack(60764-131)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-131)