3CE FULL COVER CONCEALER 001- titanium dioxide liquid 
Nanda 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 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

Image of carton

3CE FULL COVER CONCEALER 001 
titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.65 g  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-098-021 in 1 CARTON08/20/2016
1NDC:60764-098-015 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/20/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075repack(60764-098)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-098)

Revised: 10/2016
Document Id: 53f10a8e-24a8-41c4-85b6-9cd8685eab41
Set id: 17ec1e43-93cd-47f5-b063-f8883fdbefda
Version: 1
Effective Time: 20161012
 
Nanda Co., Ltd