SONATURAL POW DER4ROOM FIXING IT FULL COVER NEUTRAL BEIGE- titanium dioxide, zinc oxide cream 
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: Titanium Dioxide 20.1%, Zinc Oxide 6.3%

INACTIVE INGREDIENT

Inactive ingredients: Cyclopentasiloxane, Water, Methyl Methacrylate Crosspolymer, Butylene Glycol, CI 77492, Dicaprylyl Carbonate, Glycerin, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Beeswax, Cetearyl Alcohol, PEG-10 Dimethicone, Triethoxycaprylylsilane, CI 77491, Disteardimonium Hectorite, Tocopheryl Acetate, Sodium Chloride, Dimethicone/PEG-10/15 Crosspolymer, Portulaca Oleracea Extract, Aluminum Hydroxide, CI 77499, Phenoxyethanol, Triethyl Citrate, Caprylyl Glycol, Boron Nitride, Silica, Mica (CI 77019), 1,2-Hexanediol, Ethylhexylglycerin, Adenosine, Calendula Officinalis Flower Extract, Disodium EDTA, Propylene Glycol, Dipropylene Glycol, Rosa Canina Fruit Oil, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Sodium Citrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol

PURPOSE

Purpose: Sunscreen

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

DESCRIPTION

Indications & Usage: In base make up stage, take up adequate amount and smooth evenly to the face from the inside of the face outward.

Dosage & Administration: Take up adequate amount and smooth evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SONATURAL POW DER4ROOM FIXING IT FULL COVER NEUTRAL BEIGE 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71322-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide9.04 g  in 45 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.83 g  in 45 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71322-120-021 in 1 CARTON03/02/2017
1NDC:71322-120-0145 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/02/2017
Labeler - Sonatural Global Co.,Ltd (694818511)
Registrant - Sonatural Global Co.,Ltd (694818511)
Establishment
NameAddressID/FEIBusiness Operations
Sonatural Global Co.,Ltd694818511relabel(71322-120)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(71322-120)

Revised: 3/2017
Document Id: ff56f8a1-aed0-4ce5-bf22-f9df2ec398d4
Set id: ec631e30-22e2-4fd5-a7b4-b677d1b582d6
Version: 2
Effective Time: 20170323
 
Sonatural Global Co.,Ltd