3CE FITTING CUSHION FOUNDATION 001- titanium dioxide, octinoxate, octisalate powder 
Nanda Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of carton

3CE FITTING CUSHION FOUNDATION 001 
titanium dioxide, octinoxate, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.69 g  in 12 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.80 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.48 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-131-022 in 1 CARTON08/10/2016
1NDC:60764-131-0112 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/10/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075repack(60764-131)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-131)

Revised: 10/2016
Document Id: 418e77e4-0c9a-4f59-9043-4b4840891ddc
Set id: 1fca9d20-6a3c-40c8-8978-de46c5eb85fc
Version: 1
Effective Time: 20161017
 
Nanda Co., Ltd