3CE FULL COVER CONCEALER 001- titanium dioxide liquid

3CE FULL COVER CONCEALER 001 by

Drug Labeling and Warnings

3CE FULL COVER CONCEALER 001 by is a Otc medication manufactured, distributed, or labeled by Nanda Co., Ltd, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 13.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Butylene Glycol, CetylEthylhexanoate, Triethylhexanoin, Mica (CI 77019), Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Iron Oxides (CI 77492), DisteardimoniumHectorite, Dicaprylyl Carbonate, Beeswax, Polyglyceryl-4 Isostearate, Magnesium Sulfate, SorbitanIsostearate, Dimethicone/Vinyl DimethiconeCrosspolymer, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Aluminum Hydroxide, Methylparaben, Chlorphenesin, Iron Oxides (CI 77499), Silica, Propylparaben, Disodium EDTA, Aloe Barbadensis Leaf Juice, PolyvinylalcoholCrosspolymer, Sodium Hyaluronate, GlycyrrhizaGlabra (Licorice) Root Extract, Natto Gum, Nylon-12 Fluorescent Brightener 230 Salt, Potassium Sorbate, Sodium Benzoate

PURPOSE

Purpose: Sunscreen

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

DESCRIPTION

INSTRUCTIONS: A stick type concealer with sleek ends can be used on a variety of areas from narrow to wide areas on face.

Directions: Apply on concerned area with rednesses, dark spot areas to brighten up.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3CE FULL COVER CONCEALER 001 
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.65 g  in 5 mL

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: 60764-098-02	1 in 1 CARTON	08/20/2016
1	NDC: 60764-098-01	5 mL in 1 BOTTLE; 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	08/20/2016

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
Nanda Co., Ltd		557816075	repack(60764-098)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-098)