Label: DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 23, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients     Purpose

    Avobenzone 3%      Sunscreen

    Homosalate 4%      Sunscreen

    Octinoxate 6%       Sunscreen

    Octisalate 3%        Sunscreen           

  • PURPOSE

    Uses Helps prevent sunburn

    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    Warnings For external Use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes

    Rinse with water to remove

    If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions Apply 15 minutes prior to sun exposure

    Use a water resistant if swimming or sweating

    Reapply at least every 2 hours

    Children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, WaterInactive Ingredients Alcohol Denat., Caprylic Capric Triglyceride, Dicaprylyl Carbonate, Isododecane, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate, Water

  • PRINCIPAL DISPLAY PANEL

    Defense Refresh Setting Mist

    With Rosemary

    Broad Spectrum Sunscreen SPF 50

    Matte finish three in one

    sets make-up, controls oil and delivers UV photoaging protection

    label

    box

  • INGREDIENTS AND APPEARANCE
    DEFENSE REFRESH SETTINGH MIST BROAD SPECTRUM SUNSCREEN SPF 50  SUPERGOOP
    avobenzone, homosalate, octinoxate, octisalate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-133-021 in 1 BOX01/09/2015
    1NDC:75936-133-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:75936-133-041 in 1 BOX01/09/2015
    2NDC:75936-133-0330 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:75936-133-061 in 1 BOX01/09/2015
    3NDC:75936-133-0515 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/09/2015
    Labeler - Taylor James, LTD (033381850)
    Registrant - Taylor James, LTD (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell Pharmaceuticals140653770manufacture(75936-133)
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