3CE TINTED MOISTURE CUSHION CC 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 8.9%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-8 Dimethicone, Glycerin, Niacinamide, Pentylene Glycol, Trimethylsiloxysilicate, Methyl Methacrylate Crosspolymer, Neopentyl Glycol Diheptanoate, Dimethicone/Vinyl DimethiconeCrosspolymer, Diphenylsiloxy Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, PEG-8, Iron Oxides (CI 77492), Magnesium Sulfate, DisteardimoniumHectorite, Vinyl Dimethicone/MethiconeSilsesquioxaneCrosspolymer, SorbitanIsostearate, Phenoxyethanol, Mica (CI 77019), Stearic Acid, Alumina, Fragrance(Parfum), Iron Oxides (CI 77491), DimethiconeCrosspolymer, Triethoxycaprylylsilane, Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Disodium EDTA, Hydrogenated Castor Oil Isostearate, Hydrolyzed Hyaluronic Acid, AnastaticaHierochuntica Extract, Alcohol, GentianaLutea Root Extract, AchilleaMillefolium Extract, Artemisia Absinthium Extract, Arnica Montana Flower 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: Layering Cushion CC covers face moisture as if it has done treatment. 3CE Tinted Moisture Cushion CC creates a moisture layer with a hydrating complex for dewy radiance.

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 TINTED MOISTURE CUSHION CC 001 
titanium dioxide, octinoxate, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.06 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)  
Dimethicone (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-129-022 in 1 CARTON08/10/2016
1NDC:60764-129-0112 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(60764-129)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-129)

Revised: 10/2016
Document Id: 445175f7-b886-473d-b5b4-1b3ff3fddb75
Set id: 670674cb-c00e-491d-af0e-7f86abd40252
Version: 1
Effective Time: 20161017
 
Nanda Co., Ltd