Label: 3CE FITTING CUSHION FOUNDATION 001- titanium dioxide, octinoxate, octisalate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 60764-131-01, 60764-131-02 - Packager: Nanda Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 17, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
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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
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INGREDIENTS AND APPEARANCE
3CE FITTING CUSHION FOUNDATION 001
titanium dioxide, octinoxate, octisalate powderProduct 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)
