3CE LIP LACQUER BON BON- dimethicone 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: Dimethicone 12.0%

INACTIVE INGREDIENT

Inactive Ingredients: Phenyl Trimethicone, Octyldodecanol, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Bis-Diglyceryl Polyacyladipate-2, Isononyl Isononanoate, Kaolin, Diisostearyl Malate, HDI/Trimethylol Hexyllactone Crosspolymer, Titanium Dioxide (CI 77891), Silica Silylate, Polyglyceryl-2 Triisostearate, VP/Hexadecene Copolymer, Microcrystalline Wax, Sorbitan Isostearate, Iron Oxides (CI 77492), Yellow 5 Lake (CI 19140), Red 6 (CI 15850), Iron Oxides (CI 77491), Tocopheryl Acetate, Red 7 (CI 15850:1), Polyglyceryl-2 Diisostearate, Dehydroacetic Acid, Borago Officinalis Seed Oil, Hydrolyzed Collagen, Helianthus Annuus (Sunflower) Seed Oil

PURPOSE

Purpose: Skin Protectant

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

KEEP OUT OF REACH OF CHILDREN

keep it out of children's reach

INSTRUCTIONS

INSTRUCTIONS: Clear lip stick and powdery soft cashmere lip lacquer

Directions

Directions: Either you can fully fill in your lips with its color or shade in the center of your lips then pat it for a gradational effect.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

3CE LIP LACQUER BON BON 
dimethicone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.76 g  in 6.4 g
Inactive Ingredients
Ingredient NameStrength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Octyldodecanol (UNII: 461N1O614Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-031-021 in 1 CARTON08/01/201612/01/2018
1NDC:60764-031-016.4 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/201612/01/2018
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-031)

Revised: 5/2019
 
Nanda Co., Ltd