SUNSCREEN MIST BROAD SPECTRUM SPF 50 SUPERGOOP (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) SPRAY [TAYLOR JAMES, LTD.]

SUNSCREEN MIST BROAD SPECTRUM SPF 50 SUPERGOOP (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) SPRAY [TAYLOR JAMES, LTD.]
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NDC 75936-124-01, 75936-124-02, 75936-124-03
Set ID 777142f9-8d5a-468b-8d58-08e94b9ac0fc
Category HUMAN OTC DRUG LABEL
Packager TAYLOR JAMES, LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Avobenzone 3% Sunscreen

    Homosalate 10% Sunscreen

    Octinoxate 7.5% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 10% Sunscreen

    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

    Stop use and ask a doctor if rash occurs

    Warnings Flammable. Keep away from flames and sparks

    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.

    Directions

    Apply liberally 15 minutes before sun exposure

    Reapply:

    after 80 minutes of swimming or sweating

    immediately after towel drying

    at least every 2 hours when exposed to sunlight

    Children under 6 months: Ask a doctor

    Inactive Ingredients Alcohol Denat , Camellia Sinensis Leaf Extract, Cananga Odorata Flower Oil, Caprylic/Capric triglyceride, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon Fruit Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Sinensis Peel Oil, Dicaprylyl Carbonate, Diisopropyl Adipate, Euterpe Oleracea Fruit Extract, Helianthuus Annuus (Sunflower) Seed Oil, Isodecyl Neopentanoate, Lavandula Angustifolia Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil.

  • PRINCIPAL DISPLAY PANEL

    can label

    Water resistant (80 minutes)

    Apply to wet or dry skin

    twist-lock cap

    SPF 50 sunscreen

    Antioxidant-Infused

    Sunscreen Mist

    with Vitamin C

    Broad Spectrum

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN MIST BROAD SPECTRUM SPF 50  SUPERGOOP
    avobenzone, homosalate, octinoxate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-124
    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) HOMOSALATE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LIME OIL (UNII: UZH29XGA8G)  
    CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    MANDARIN OIL (UNII: NJO720F72R)  
    ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    ACAI (UNII: 46AM2VJ0AW)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-124-021 in 1 PACKAGE01/29/2013
    1NDC:75936-124-01177 mL in 1 CAN; Type 0: Not a Combination Product
    2NDC:75936-124-0389 mL in 1 CAN; Type 0: Not a Combination Product01/29/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/29/2013
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555manufacture(75936-124)

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