Label: UV SHIELD SPF 42- octinoxate liquid

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

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Drug Label Information

Updated March 2, 2018

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  • ACTIVE INGREDIENT

    active ingredient: ethylhexyl methoxycinnamate

  • INACTIVE INGREDIENT

    Inactive ingredients: water, cyclomethicone, titanium dioxide, alcohol, ethylhexyl salicylate, butylene glycol, zinc oxide, dicaprylyl carbonate, talc, sodium chloride, methylparaben, centella asiatica extract

  • PURPOSE

    Silky and extremely lightweight, this non-greasy formula smoothes on an invisible veil of UVA/UVB prevention, while natural plant extracts help soothe and repair the skin. Very water-resistant for lasting protection.

  • 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
    UV SHIELD SPF 42 
    octinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75847-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    OCTISALATE (UNII: 4X49Y0596W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    TALC (UNII: 7SEV7J4R1U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75847-0001-170 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2011
    Labeler - IASO Inc (688771690)
    Registrant - IASO Inc (688771690)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd689512611manufacture(75847-0001)
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