SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) SPRAY [VI-JON]

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SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) SPRAY [VI-JON]
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NDC 0869-0787-30, 0869-0787-38
Set ID c67e4c0f-85f2-4be1-b306-4a22d1f3a793
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Avobenzone 3%

    Homosalate 15%

    Octisalate 5%

    Oxybenzone 6%

  • Purpose

    Sunscreen

  • Use

    • 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
  • Warnings

    For external use only

  • Flammable:

    Do not use near heat, flame, or while smoking.

  • 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

  • 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 Broad Spectrum SPF value of 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
    • avoid long term storage above 40°C (104°F)
  • Inactive ingredients

    alcohol denat., acrylates/octylacrylamide copolymer, glycerin, Aloe barbadensis leaf extract, fragrance, Cocos nucifera (coconut) oil, mineral oil

  • SPL UNCLASSIFIED SECTION

    May stain or damage some fabrics or surfaces

    *This product is not manufactured or distributed by Bayer, distributor of Coppertone Sport High Performance Sunscreen Continuous Spray UVA/UVB Broad Spectrum SPF 50.

    Made in the USA with US and foreign parts.

    Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

    www.mymountainfalls.com

  • principal display panel

    mountain falls

    Compare to Coppertone

    paraben free

    water resistant 80 minutes

    SPF 50

    sweat resistant sport sunscreen spray

    BROAD SPECTRUM SPF 50

    UVA/UVB sunscreen

    NET WT 10 (283 g)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    avobenzone, homosalate, octisalate, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0787
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone26.49 mg  in 1 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate132.45 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate44.15 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE52.98 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0787-30170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/07/2017
    2NDC:0869-0787-38283 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/07/2017
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0787)
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