Cover 10 Perfect Foundation BP15 by F&CO Co., Ltd. / COSMAX INC.

Drug Details [pdf]

COVER 10 PERFECT FOUNDATION BP15- titanium dioxide, octinoxate, zinc oxide cream
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 INGREDIENTS: Titanium Dioxide (CI 77891) (13.27%), Ethylhexyl Methoxycinnamate (4.0%), Zinc Oxide (CI 77947) (0.97%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Methyl Trimethicone, Glycerin, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Trimethylsiloxysilicate, Niacinamide, Caprylyl Methicone, Pentylene Glycol, Dimethicone, Diphenylsiloxy Phenyl Trimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Isosteareate, Phenoxyethanol, Tribehenin, Iron Oxides (CI 77491), Aluminum Hydroxide, Triethoxycaprylylsilane, Acrylates/Dimethicone Copolymer, Polyhydroxystearic Acid, Dimethicone Crosspolymer, Fragrance, Stearic Acid, Iron Oxides (CI 77499), Ethylhexyl Palmitate, Lecithin, Isostearic Acid, Isopropyl Myristate, Ethylhexylglcerin, Adenosine, Polyglceryl-3 Polyricinoleate, Disodium EDTA, Lauroyl Lysine, Vinyl ?Dimethicone / Methicone Silsesquioxane Crosspolymer, Trehalose, Lavandula Angustifolia (Lavender) Flower Water, Polysilicone-11, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Silica Dimethyl Cerifera (Carnauba) Wax, Hydrogenated Castor Oil Isostearate, Pistacia Lentiscus (Mastic) Gum, Ceramide, Caprylyl Glycol, Actinidia Polygama Fruit Extract, Portulaca Oleracea Extract, Citric Acid, Vanilla Planifolia Fruit Extract, Sodium Benzoate, Potassium Sorbate, Hexylene Glycol, Caprylhydroxamic Acid

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. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

INDICATIONS & USAGE

INDICATIONS & USAGE: Shake well, pump gently, and blend effortlessly. Apply a small amount evenly over entire face. Re-apply as necessary to build desired coverage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

COVER 10 PERFECT FOUNDATION BP15
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-390
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.98 mg in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.20 mg in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.29 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69106-390-01	30 mL 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(69106-390)

Revised: 1/2020

Document Id: bf81b2bb-955f-491b-b791-eef9280847b5

Set id: 6ecfae21-bb77-4075-8530-08f35062899e

Version: 2

Effective Time: 20200103

F&CO Co., Ltd.