Drug Details [pdf]

3CE LIP LACQUER BACKSTAGE- 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, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Silica, Bis-Diglyceryl Polyacyladipate-2, Isononyl Isononanoate, Kaolin, HDI/Trimethylol Hexyllactone Crosspolymer, Diisostearyl Malate, Polyglyceryl-2 Triisostearate, Silica Silylate, Yellow 6 Lake (CI 15985), Red 7 (CI 15850:1), VP/Hexadecene Copolymer, Polyglyceryl-2 Diisostearate, Microcrystalline Wax, Sorbitan Isostearate, Yellow 5 Lake (CI 19140), Tocopheryl Acetate, 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 BACKSTAGE
dimethicone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-027
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.76 g in 6.4 g

Ingredient Name	Strength
Inactive Ingredients
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Octyldodecanol (UNII: 461N1O614Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 60764-027-02	1 in 1 CARTON	08/01/2016	12/01/2018
1	NDC: 60764-027-01	6.4 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/01/2016	12/01/2018

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(60764-027)

Revised: 5/2019

Document Id: 256ee541-3ad2-42a0-b7ab-06924400f1f8

Set id: f35e914d-22cf-48e4-b8e6-f96eefa5e934

Version: 2

Effective Time: 20190521

Drug Labeling and Warnings