Cover 10 Perfect BB Natural by F&CO Co., Ltd. / COSMAX INC.

Cover 10 Perfect BB Natural by

Drug Labeling and Warnings

Cover 10 Perfect BB Natural 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]

COVER 10 PERFECT BB NATURAL- 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.

----------

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: Titanium Dioxide (CI 77891) (15.71%), Ethylhexyl Methoxycinnamate (7.0%), Zinc Oxide (CI 77947) (3.91%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Phenyl Trimethicone, Niacinamide, Cetyl Ethylhexanoate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Pentylene Glycol, Sorbitan Isostearate, Isoamyl p-Methoxycinnamate, Iron Oxides (CI 77492), Disteardimonium Hectorite, Magnesium Sulfate, Mica (CI 77019), Aluminum Hydroxide, PEG-8 Dimethicone, Phenoxyethanol, Glyceryl Tribehenate/Isostearate/Eicosandioate, Stearic Acid, Iron Oxides (CI 77491), Tribehenin, Fragrance(Parfum), Iron Oxides (CI 77499), Dimethicone, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Ethylhexylglcerin, Adenosine, Hydrogenated Castor Oil Isostearate, Disdoium EDTA, Cyclomethicone, Polysilicone-11, Lauroyl Lysine, Trehalose, Lavandula Angustifolia (Lavender) Flower Water, Ethylhexyl Palmitate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Silica Dimethyl Siylate, Lecithin, Pistacia Lentiscus (Mastic) Gum, Ceramide 3, Caprylyl Glycol, Actinidia Polygama Fruit Extract, Portulaca Oleracea Extract, Citric Acid, Vanilla Planifolia Fruit Extract, Sodium Benzoate, Sodium Hyaluronate, 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: Spread gently onto face and blend to desired coverage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COVER 10 PERFECT BB NATURAL 
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.71 mg  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.10 mg  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.17 mg  in 30 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-360-01	30 mL in 1 CARTON; Type 0: Not a Combination Product	03/01/2015	11/01/2019

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

Labeler - F&CO Co., Ltd. (690166186)

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69106-360)

Revised: 1/2020

Document Id: 0e10bc8e-1962-4216-8067-337a9b9b0de3

34390-5

Set id: 7c7989fb-7bc3-4949-89fd-5ab15acc7d3b

Version: 2

Effective Time: 20200103

 

F&CO Co., Ltd.