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

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [VI-JON]
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NDC 0869-0752-34
Set ID 2a81bd41-80cf-4e71-bcdc-169543b228ef
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Homosalate 13%

    Octisalate 5%

    Octocrylene 7%

    Oxybenzone 4%

  • 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

  • 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
  • Inactive ingredients

    water, sorbitol, triethanolamine, VP/eicosene copolymer, stearic acid, sorbitan isostearate, aluminum starch octenylsuccinate, benzyl alcohol, dimethicone, tocopherol, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA

  • SPL UNCLASSIFIED SECTION

    May stain or damage some fabrics or surfaces

    *This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Water Babies 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

    non-irritating

    sunscreen for babies

    BROAD SPECTRUM SPF 50

    UVA/UVB

    SUNSCREEN

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0752
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone30.9 mg  in 1 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate133.9 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate51.5 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE72.1 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone41.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    tocopherol (UNII: R0ZB2556P8)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0752-34236 g in 1 BOTTLE, PLASTIC; 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(0869-0752)

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