KIDS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) STICK [VI-JON]

KIDS SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) STICK [VI-JON]
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NDC 11344-791-84
Set ID d37147d4-2161-4a68-a60b-bb35f79cc4a4
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon
Generic Name
Product Class
Product Number
Application Number PART352
  • claims

    SOLAR SCREEN

    KIDS SUNSCREEN STICK SPF 55

    Broad Spectrum SPF 55

  • Active ingredients

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Octocrylene 10%

    Oxybenzone 6%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the riskof skin cancer and early skin aging caused by the sun
  • 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 section if

    • rash occurs
  • Keep out of reach of children

    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
    • Sun Protection Measures.  Spending time 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 or 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.  - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor
  • Other information

    • protect the product from excessive heat and direct sun
  • inactive ingredients

    beeswax, lauryl laurate, polybutene, cetyl alcohol, ozokerite, cetearyl behenate, myristyl myristate, styrene/acrylates copolymer, tocopherol, Theobroma cacao (cocoa) seed butter, retinyl palmitate, phenoxyethanol, tetrahexyldecyl ascorbate

  • disclaimer

    May stain or damage some fabrics or surfaces

    this product is not manufactured or distributed by Bayer distributor of Coppertone Kids Sunscreen Stick Broad Spectrum SPF 55

  • Disclaimer

    Distributed by: Vi-Jon, Inc.
    8515 Page Ave.
    St. Louis, MO 63114
    791.000/791AA

  • principal display panel

    SPF 55

     SOLAR SCREEN

    KIDS

    SUNSCREEN

    STICK SPF 55

    Broad Spectrum

    SPF 55

    Water Resistant

    (80 minutes)

    Pediatrician Tested

    PABA Free

    Compare to

    Coppertone

    NET WT

    0.6 OZ (17g)

    image description

  • INGREDIENTS AND APPEARANCE
    KIDS SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-791
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) homosalate150 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) octocrylene100 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CETEARYL BEHENATE (UNII: 7ARI9LTH0U)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-791-841 in 1 BLISTER PACK07/01/2017
    117 g in 1 APPLICATOR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/01/2017
    Labeler - Vi-Jon (150931459)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(11344-791)

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