3CE PORE SILKY BALM- titanium dioxide powder

3CE PORE SILKY BALM by

Drug Labeling and Warnings

3CE PORE SILKY BALM by is a Otc medication manufactured, distributed, or labeled by Nanda Co., Ltd, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Dimethicone, Silica, Phenyl Trimethicone, IsotridecylIsononanoate, Methyl Methacrylate Crosspolymer, SorbitanOlivate, Microcrystalline Wax, Vinyl Dimethicone/MethiconeSilsesquioxaneCrosspolymer, Stearoyl Inulin, Polyethylene, Talc, Hydroxyapatite, Acetylated Sucrose Distearate, Diisostearyl Malate, Butylparaben, Fragrance(Parfum), Methicone, Polyglyceryl-2 Triisostearate, Yellow 5 Lake (CI 19140), Macadamia Integrifolia Seed Oil, ButyrospermumParkii (Shea) Butter, ArganiaSpinosa Kernel Oil, PolyvinylalcoholCrosspolymer, Nylon-12 Fluorescent Brightener 230 Salt

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: Primer that conceals your rough, bumpy skin for a smooth canvas finish.

Directions: Apply on concerned areas with wide pores then proceed to base make-up.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3CE PORE SILKY BALM 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.12 g  in 25 g

Inactive Ingredients
Ingredient Name	Strength
Dimethicone (UNII: 92RU3N3Y1O)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-014-02	1 in 1 CARTON	08/10/2016
1	NDC: 60764-014-01	25 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/10/2016

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
Nanda Co., Ltd		557816075	repack(60764-014)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-014)