V V BOUNCING CUSHION BE10 by F&CO Co., Ltd. / Cosmax, Inc

V V BOUNCING CUSHION BE10 by

Drug Labeling and Warnings

V V BOUNCING CUSHION BE10 by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

V V BOUNCING CUSHION BE10- titanium dioxide, octinoxate, octisalate powder 
F&CO 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 10.32%, Ethylhexyl Methoxycinnamate 6.70%, Ethylhexyl Salicylate 4.00%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Mica (CI 77019), Glycerin, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Trimethylsiloxysilicate, Pentylene Glycol, Disteardimonium Hectorite, Dimethicone, Caprylyl Methicone, Phenyl Trimethicone, Iron Oxides (CI 77492), Magnesium Sulfate, Cetyl PEG/PPG-10/1 Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Phenoxyethanol, Dimethicone Crosspolymer, Stearic Acid, Alumina, 1,2-Hexanediol, Fragrance(Parfum), Triethoxycaprylylsilane, Iron Oxides (CI 77491), Hydrolyzed Collagen, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Hydrogenated Castor Oil Isostearate, Adenosine, Iron Oxides (CI 77499), Disodium EDTA, Ceramide 3, Sodium Hyaluronate, Tocopheryl Acetate, Raspberry Seed Oil/Tocopheryl Succinate Aminopropanediol Esters, Hydrogenated Polyisobutene, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Centella Asiatica Extract, Sorbitan Laurate, Polyglutamic Acid, Silk Amino Acids, Hydroxyethylcellulose, Acetyl Dipeptide-1 Cetyl Ester, Citrus Limon (Lemon) Peel Oil, Olea Europaea (Olive) Fruit Oil, Pinus Sylvestris Leaf Oil, Anemarrhena Asphodeloides Root Extract, Salvia Sclarea (Clary) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Eucalyptus Globulus Leaf Oil, Tocopherol

WARNINGS

Warnings: If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

DESCRIPTION

Indications & Usage:

After lightly pressing the container, softly tap a moderate amount of content on correction spot or the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

V V BOUNCING CUSHION BE10 
titanium dioxide, octinoxate, octisalate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69106-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.54 g  in 2 
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.00 g  in 2 
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.60 g  in 2 
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69106-200-012 in 1 CARTON; Type 0: Not a Combination Product03/01/201511/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/201511/01/2019
Labeler - F&CO Co., Ltd. (690166186)
Registrant - F&CO Co., Ltd. (690166186)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(69106-200)

Revised: 1/2020
Document Id: 886635d8-58c5-4bc0-b040-cee663b59d52
Set id: d69feb56-fbca-437f-b16f-bc5bf4ac0a9c
Version: 3
Effective Time: 20200109
 
F&CO Co., Ltd.