3CE LIP COLOR 204 COME TO ME- titanium dioxide lipstick 
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 0.7%

INACTIVE INGREDIENT

Inactive Ingredients: Diisostearyl Malate, Caprylic/Capric Triglyceride, Polyglyceryl-2 Triisostearate, Triethylhexanoin, Pentaerythrityl Tetraethylhexanoate, Ricinus Communis (Castor) Seed Oil, Ozokerite, Diglyceryl Sebacate/Isopalmitate, Petrolatum, Mica (CI 77019), Ceresin, Red 6 (CI 15850), Bis-Diglyceryl Polyacyladipate-2, Glyceryl Ethylhexanoate/Stearate/Adipate, Dicalcium Phosphate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Euphorbia Cerifera (Candelilla) Wax, Polyethylene, Silica, Hydrogenated Vegetable Oil, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Methyl Methacrylate Crosspolymer, Yellow 6 Lake (CI 15985), Methicone, Cholesteryl Macadamiate, Methylparaben, Yellow 5 Lake (CI 19140), Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea) Butter, Water, Butylene Glycol, Diamond powder, Amethyst Powder, Pearl Powder, Tourmaline

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 rich color lipstick that moistly adheres to lips.

Directions: Twist to dispense makeup and apply evenly to lips

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

3CE LIP COLOR 204 COME TO ME 
titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.02 g  in 3.5 g
Inactive Ingredients
Ingredient NameStrength
Diisostearyl Malate (UNII: QBS8A3XZGQ)  
Triethylhexanoin (UNII: 7K3W1BIU6K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-067-021 in 1 CARTON08/01/2016
1NDC:60764-067-013.5 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075repack(60764-067)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-067)

Revised: 10/2016
Document Id: f41d11f5-7673-4e87-98b5-bce4a757ca0e
Set id: bcf51461-d6cd-47a2-a7b5-a43de50265ec
Version: 1
Effective Time: 20161005
 
Nanda Co., Ltd