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SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK

Medically reviewed on March 23, 2017

Dosage form: powder
Ingredients: Dimethicone 0.12g in 6g
Labeler: Sonatural Global Co.,Ltd
NDC Code: 71322-050

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.

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

SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK 
dimethicone powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71322-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (DIMETHICONE) Dimethicone0.12 g  in 6 g
Inactive Ingredients
Ingredient NameStrength
Talc 
Phenyl Trimethicone 
Packaging
#Item CodePackage Description
1NDC:71322-050-021 CONTAINER in 1 CARTON
1NDC:71322-050-016 g in 1 CONTAINER
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/FEIOperations
Sonatural Global Co.,Ltd694818511relabel(71322-050)
Establishment
NameAddressID/FEIOperations
Cosmecca Korea Co., Ltd.688830827manufacture(71322-050)

 
Sonatural Global Co.,Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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