Label: IASO SMART PACT 23- zinc oxide powder

  • 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 March 2, 2018

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  • ACTIVE INGREDIENT

    zinc oxide


  • INACTIVE INGREDIENT

    mica, talc, titanium dioxide, silica, dimethicone, boron nitride, dimethicone/vinyl dimethicone crosspolymer, ci 77492, zinc myristate, cetyl caprylate, vinyl dimethicone/methicone silsesquioxane crosspolymer, aluminium hydroxide, stearic acid, aluminum starch octenylsuccinate, aluminum dimyristate, ci 77491, glyceryl rosinate, methicone, octyldodecyl myristate, c9-15 fluoroalcohol phosphate, magnesium myristate, methylparaben, dimethicone/methicone copolymer, fragrance, tocopheryl acetate, trimethylsiloxysilicate, ci 77499, propylparaben, lycium chinense fruit ext, cornus officinalis fruit ext, schizandra chinensis fruit ext


  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply the powder to the attached puff and gently pat onto the face following the application of IASO triple protection bb spf 30 pa++ or essence liquid foundation


  • WARNINGS

    - Stop using if sensitivities occurs and consult with dermatologist
    - sensitivities such as red marks, intumescence, urtication, irritation during use
    -Have sensitivities as above on applied part by direct sun ray
    - Do not store at high and low temperatures and avoid sunlight.


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    IASO SMART PACT 23 
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75847-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0291 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75847-0004-110 g in 1 PACKAGE; Type 0: Not a Combination Product03/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2013
    Labeler - IASO Inc (688771690)
    Registrant - IASO Inc (688771690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd689847167manufacture(75847-0004)
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