V V BOUNCING CUSHION BP15 by F&CO Co., Ltd. / Cosmax, Inc

Drug Details [pdf]

V V BOUNCING CUSHION BP15- 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, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Hydrolyzed Collagen, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Iron Oxides (CI 77499), Hydrogenated Castor Oil Isostearate, Adenosine, 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

PURPOSE

Purpose: Sunscreen

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.

INDICATIONS & USAGE

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 carton

V V BOUNCING CUSHION BP15
titanium dioxide, octinoxate, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-220
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.54 g in 2
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.00 g in 2
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.60 g in 2

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69106-220-01	2 in 1 CARTON; Type 0: Not a Combination Product	03/01/2015	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2015	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

Registrant - F&CO Co., Ltd. (690166186)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(69106-220)

Revised: 1/2020

Document Id: 07674254-d672-40e7-a017-b5c30f7feec7

Set id: 2becb4ad-f57a-47bc-96cb-a83a59fce9cb

Version: 3

Effective Time: 20200109