SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK- dimethicone powder

SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK by

Drug Labeling and Warnings

SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK by is a Otc medication manufactured, distributed, or labeled by Sonatural Global Co.,Ltd, Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Dimethicone 2.0%

INACTIVE INGREDIENT

Inactive ingredients: Talc, Silica, Methyl Methacrylate Crosspolymer, Caprylic/Capric Triglyceride, Boron Nitride, Phenyl Trimethicone, Triethoxycaprylylsilane, Magnesium Stearate, Diisostearyl Malate, Caprylyl Glycol, Ethylhexylglycerin, CI 77491, Mica (CI 77019), 1,2-Hexanediol, Titanium Dioxide (CI 77891), CI 77499, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Red 7, Methicone, Tin Oxide, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. If the following symptoms occur, discontinue use and consult a dermatologist: 1) Red spots, swelling, itchiness, or irritation upon use 2) If above symptoms occur when skin is in direct sunlight 2. Do not use on open wounds and on skin with eczema or dermatitis 3. Storage instructions: 1) Close lid tightly after each use 2) Keep out of reach of children 3) Store at room temperature away from direct sunlight

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Apply and pat lightly to the eye area before makeup, or sebaceous gland area after makeup with the puff.

DOSAGE & ADMINISTRATION

Dosage & Administration: Get appropriate amount onto puff and pat lightly and evenly over the eye or sebaceous gland area.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK 
dimethicone powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71322-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.12 g  in 6 g

Inactive Ingredients
Ingredient Name	Strength
Talc (UNII: 7SEV7J4R1U)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71322-050-02	1 in 1 CARTON	03/02/2017
1	NDC: 71322-050-01	6 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 final	part347	03/02/2017

Labeler - Sonatural Global Co.,Ltd (694818511)

Registrant - Sonatural Global Co.,Ltd (694818511)

Establishment
Name	Address	ID/FEI	Business Operations
Sonatural Global Co.,Ltd		694818511	relabel(71322-050)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co., Ltd.		688830827	manufacture(71322-050)