WATERFUL SUN (ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE) GEL [ARI&J INC]

WATERFUL SUN (ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE) GEL [ARI&J INC]
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NDC 71496-0003-1
Set ID 5326ae14-eb97-1351-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager ARI&J Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, etc

  • PURPOSE

    • Suncreen
    • protects skin from UV rays
    • 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 or reach of the children

  • INDICATIONS & USAGE

    apply generously 15 minutes before sun sxposure

    reapply:

    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two hours

    Sun Protection Measures. Spending thime in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, expecially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

    children under 6 months of age: Ask a doctor

  • 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.
    • Stop use and ask a doctor if rash occurs.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
    • do not place this product in this container in the excessive heat and direct sun.
  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    WATERFUL SUN 
    ethylhexyl methoxycinnamate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71496-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71496-0003-150 mL in 1 TUBE; Type 0: Not a Combination Product06/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/30/2017
    Labeler - ARI&J Inc (694174441)
    Registrant - ARI&J Inc (694174441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(71496-0003)
    Establishment
    NameAddressID/FEIBusiness Operations
    ARI&J Inc694174441label(71496-0003) , pack(71496-0003)

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