Label: DR. IASO- octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 2, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    active ingredient: ETHYLHEXYL METHOXYCINNAMATE

  • INACTIVE INGREDIENT

    Inactive ingredients: water, cyclopentasiloxane, ethylhexyl salicylate, zinc oxide, butylene glycol, dipropylene glycol, glycrrin, peg-10 dimethicone, titanium dioxide, dicaprylyl carbonate, disteardimonium hectorite, magnesium sulfate, dimethicone, calcium aluminum borosilicate, methyl methacrylate crosspolymer, mica, phenoxyethanol, aluminum hydroxide, dimethicone/vinyl dimethicone crosspolymer, aluminum stearate, dimethicone/vinyl dimethicone crosspolymer, aluminum stearate, fragrance, methicone, caprylyl glycol, glyceryl caprylate, microcrystalline cellulose, polyglyceryl-6 polyricinoleate, bambusa vulgaris water, eut6erpe oleracea fruit extract, tocopheryl acetate, vaccinium angustifolium fruit extract, dianthus chinensis extract, nelumbo nucifera flower extract, basil, camellia sinensis, centella asiatica, houttuynia cordata, perilla ocymoides, rosemary, acacia farnesiana, lilium tigrinum, magnolia liliflora, prunus mume, peach, prunus serrulata, thymus quinquecostatus, triethoxycaprylyls, cellulose gum, CI 77492, CI 77491

  • PURPOSE

    high level daily sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Use before when exposed by the sun

  • WARNINGS

    do not use when you feel itching
    do not swallow
    clean the skin before use

  • DOSAGE & ADMINISTRATION

    Shake well and apply evenly before sunning
    Reapply frequently, and after swimming, perspiring or toweling off

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    DR. IASO 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75847-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    OCTISALATE (UNII: 4X49Y0596W)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    HECTORITE (UNII: 08X4KI73EZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MICA (UNII: V8A1AW0880)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BAMBUSA VULGARIS WHOLE (UNII: WCD45M1BSK)  
    EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    DIANTHUS CHINENSIS WHOLE (UNII: E097DJ9EN0)  
    NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
    OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)  
    OOLONG TEA LEAF (UNII: U319SC75NA)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ROSEMARY (UNII: IJ67X351P9)  
    ACACIA (UNII: 5C5403N26O)  
    LILIUM LANCIFOLIUM WHOLE (UNII: 079XQO23D9)  
    MAGNOLIA LILIIFLORA FLOWER (UNII: SVM28292LH)  
    PRUNUS MUME FLOWER (UNII: 2N8872050J)  
    PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
    PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75847-0002-160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/17/2012
    Labeler - IASO Inc (688771690)
    Registrant - IASO Inc (688771690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd689512611manufacture(75847-0002)