3CE LIP COLOR 503 GLASS HOT PINK- 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 0.6%

INACTIVE INGREDIENT

Inactive Ingredients: Polyglyceryl-2 Triisostearate, Diisostearyl Malate, Caprylic/Capric Triglyceride, Pentaerythrityl Tetraethylhexanoate, Hydrogenated Polyisobutene, Ceresin, Ozokerite, Bis-Diglyceryl Polyacyladipate-2, Diglyceryl Sebacate/Isopalmitate, Octyldodecanol, Synthetic Wax, Dicalcium Phosphate, VP/Hexadecene Copolymer, Sorbitan Isostearate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Silica Dimethyl Silylate, HDI/Trimethylol Hexyllactone Crosspolymer, Ethylene/Propylene Copolymer, Phytosteryl Macadamiate, Red 28 Lake (CI 45410), Cholesteryl Macadamiate, Tocopheryl Acetate, Polyglyceryl-2 Diisostearate, Silica, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea) Butter, Yellow 5 Lake (CI 19140), Water, Butylene Glycol, Diamond powder, Amethyst Powder, Pearl Powder, Tourmaline, Methylparaben

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 503 GLASS HOT PINK 
titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-074
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)  
Pentaerythrityl Tetraethylhexanoate (UNII: XJ7052W897)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-074-021 in 1 CARTON08/01/2016
1NDC:60764-074-013.5 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(60764-074)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-074)

Revised: 10/2016
Document Id: a0a598b5-9602-49a3-9ad9-088fae19ab73
Set id: 12c4ce1e-3598-4a56-8fde-8e292bf4ce14
Version: 1
Effective Time: 20161007
 
Nanda Co., Ltd