OCTINOXATE, OCTISALATE, AVOBENZONE LOTION [VI-JON]

OCTINOXATE, OCTISALATE, AVOBENZONE LOTION [VI-JON]
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NDC 0869-0995-26
Set ID eeb04e82-0a5c-40ca-8cc2-eadd7451eca1
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Octinoxate 7.5%

    Octisalate 5.0%

    Avobenzone 3.0%

  • Purpose

    Sunscreen

  • Uses

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

    For external use only

  • Do not use

    on damaged or broken skin

  • Stop use and ask a doctor if

    rash occurs

  • When using this product

    keep out of eyes.  Rinse with water to remove.

  • 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 at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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 of 15 or highter and other sun protection measures including:
    • limit the 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
    • may stain some fabrics
  • Inactive ingredients

    water, diisopropyl adipate, cyclomethicone, glycerin, undecylcrylene dimethicone, glyceryl stearate, PEG-100 stearate, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, tocopyeryl acetate, carbomer, disodium EDTA, trietanoolamine, potassium sorbate

  • claims

    This product is not manufactured or distributed by Galdema Laboatories, L.P.,  distributor of Cetaphil Daily Facial Moisturizer SPF 15

    Manufactured by: Vi-Jon, Inc.,

    St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

  • principal display panel


    mountain

    falls

    Compare

    to Olay

    won't

    clog Pores

    UVA/UVB

    protection

    vitamin

    E & C

    enriched

    SPF

    15

    moisturizing

    beuty lotion

    broad spectrum

    SPF 15

    sunscreen

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    OCTINOXATE, OCTISALATE, AVOBENZONE 
    octinoxate, octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE76.5 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.0 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    STEARETH-2 (UNII: V56DFE46J5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0995-26141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/25/2016
    Labeler - Vi-Jon (790752542)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(0869-0995)

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