VITAMIN B5- dimethicone emulsion
NATURE REPUBLIC 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 1.00%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cetyl Ethylhexanoate, Cocos Nucifera (Coconut) Oil, Glycerin, Isopropyl Palmitate, Butyrospermum Parkii (Shea) Butter, Pentylene Glycol, Chondrus Crispus Extract, Saccharum Officinarum (Sugarcane) Extract, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Panthenol, Sorbitan Stearate, Phenoxyethanol, PEG-40 Stearate, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Palmitic Acid, Carbomer, Stearic Acid, Tromethamine, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Tocopheryl Acetate, Squalane, Disodium EDTA, Madecassoside, Polysorbate 60, Sorbitan Isostearate

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: The vitamin B5 emulsion helps sensitive skin feel moisturized and radiant.

DOSAGE & ADMINISTRATION

Dosage & Administration: After using essence, apply an appropriate amount on the entire face and gently pat to promote absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

VITAMIN B5
dimethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-435
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.50 g in 150 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Cetyl Ethylhexanoate (UNII: 134647WMX4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51346-435-02	1 in 1 CARTON	12/01/2016
1	NDC:51346-435-01	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/01/2016

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Name	Address	ID/FEI	Business Operations
Establishment
NATURE REPUBLIC CO., LTD.		631172020	relabel(51346-435)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc		689049693	manufacture(51346-435)