Label: AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 11, 2021

If you are a consumer or patient please visit this version.

  • 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 protections measures (see Directions), decreases the rist 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 a 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, tocopheryl, 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 Ultra Guard Sunscreen Lotion Broad Spectrum SPF 50.

    Made in the USA with US and foreign parts.

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

    Questions or Comments? 1-888-593-0593

    www.mymountainfalls.com

  • principal display panel

    mountain

    falls

    *Compare to Coppertone

    paraben free

    SPF

    50

    water

    resistant

    80

    minutes

    ultra

    sunscreen

    lotion

    BROAD

    SPECTRUM

    SPF 50

    UVA/UVB SUNSCREEN

    16 FL OZ (473 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.9 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE133.9 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE72.1 mg  in 1 mL
    oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) oxybenzone41.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    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:0869-0711-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/12/2016
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0711)