SONATURAL HIGH WATER DRAW SUPER HYDRA BALM- dimethicone cream

SONATURAL HIGH WATER DRAW SUPER HYDRA BALM by

Drug Labeling and Warnings

SONATURAL HIGH WATER DRAW SUPER HYDRA BALM by is a Otc medication manufactured, distributed, or labeled by Sonatural Global Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SONATURAL HIGH WATER DRAW SUPER HYDRA BALM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71322-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.5 g  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71322-040-02	1 in 1 CARTON	03/02/2017
1	NDC: 71322-040-01	75 mL 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	manufacture(71322-040)