SONATURAL POW DER4ROOM SMUDGING ZERO REMOVER- dimethicone stick 
Sonatural Global 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 ingredients: Dimethicone 12.1%

INACTIVE INGREDIENT

Inactive ingredients: Isotridecyl Isononanoate, Caprylic/Capric Triglyceride, Triethylhexanoin, Ethylhexyl Palmitate, Stearyl Dimethicone, Ceresin, Diisostearyl Malate, Sorbitan Sesquioleate, Octyldodecanol, Euphorbia Cerifera (Candelilla) Wax, Phenyl Trimethicone, Zinc Stearate, Polyethylene, Microcrystalline Wax, Disteardimonium Hectorite, Ethylhexyl Methoxycinnamate, Propylene Carbonate, Glyceryl Caprylate, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Argania Spinosa Kernel Oil, Rosa Canina Fruit Oil, Mica (CI 77019), Titanium Dioxide (CI 77891), Red 7 Lake (CI 15850:1)

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 4. Eye makeup products 1) Rinse with water immediately if contact with eyes.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Rub gently on eye areas by pink remover if desired to remove or fix make up and then wipe it out with soft sponge tip.

DOSAGE & ADMINISTRATION

Dosage & Administration: Get appropriate amount of pink remover, rub gently on eye areas and then wipe it out with soft sponge tip.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SONATURAL POW DER4ROOM SMUDGING ZERO REMOVER 
dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71322-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.18 g  in 1.5 g
Inactive Ingredients
Ingredient NameStrength
Isotridecyl Isononanoate (UNII: WEF51750MT)  
Triethylhexanoin (UNII: 7K3W1BIU6K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71322-070-021 in 1 CARTON03/02/2017
1NDC:71322-070-011.5 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/02/2017
Labeler - Sonatural Global Co.,Ltd (694818511)
Registrant - Sonatural Global Co.,Ltd (694818511)
Establishment
NameAddressID/FEIBusiness Operations
Sonatural Global Co.,Ltd694818511manufacture(71322-070)

Revised: 3/2017
Document Id: 8eef6531-c961-44f1-852b-e50772e9c08e
Set id: 0e829cea-0635-4ed7-be90-06d4deb878a6
Version: 1
Effective Time: 20170323
 
Sonatural Global Co.,Ltd