Label: VITAMIN B5- dimethicone emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 19, 2017

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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

    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

  • INGREDIENTS AND APPEARANCE
    VITAMIN B5 
    dimethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-435
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.50 g  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl Ethylhexanoate (UNII: 134647WMX4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51346-435-021 in 1 CARTON12/01/2016
    1NDC:51346-435-01150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/01/2016
    Labeler - NATURE REPUBLIC CO., LTD. (631172020)
    Registrant - NATURE REPUBLIC CO., LTD. (631172020)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURE REPUBLIC CO., LTD.631172020relabel(51346-435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(51346-435)
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