SONATURAL HIGH WATER DRAW SUPER HYDRA BALM- dimethicone 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: Dimethicone 2.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Butylene Glycol, Cetyl Ethylhexanoate, Cyclopentasiloxane, Cetearyl Alcohol, Betaine, Stearic Acid, Caprylic/Capric Triglyceride, Glyceryl Stearate, Pentaerythrityl Tetraisostearate, PEG-100 Stearate, 1,2-Hexanediol, Polysorbate 60, Sodium Polyacrylate Starch, Sorbitan Stearate, Ethylhexylglycerin, Scutellaria Baicalensis Root Extract, Fragrance, Cocos Nucifera (Coconut) Fruit Juice, Cocos Nucifera (Coconut) Water, Hyacinthus Orientalis Extract, Hydrolyzed Collagen, Glycine Soja (Soybean) Germ Extract, Hydrolyzed Adansonia Digitata Extract, Glyceryl Caprylate, Disodium EDTA, Blue 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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Take up an adequate amount and then smooth it on your face to help it absorb in the last step of your day and night skin care.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take up adequate amount and apply it evenly onto your face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SONATURAL HIGH WATER DRAW SUPER HYDRA BALM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71322-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.5 g  in 75 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71322-040-021 in 1 CARTON03/02/2017
1NDC:71322-040-0175 mL 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(71322-040)

Revised: 3/2017
Document Id: 309930d3-71b5-46d8-b0b2-12890906571d
Set id: f9e622bb-74f7-4843-9eeb-bcfd93cb6a7f
Version: 2
Effective Time: 20170323
 
Sonatural Global Co.,Ltd