Label: FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN- homosalate, octisalate aerosol, spray

  • NDC Code(s): 62217-042-37, 62217-042-74
  • Packager: FRUIT OF THE EARTH, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 20, 2021

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  • Active ingredients

    Homosalate 7.0%, Octisalate 5.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • FLAMMABLE:

    • do not use near heat, flame or while smoking
    • avoid long term storage above 104°F (40°C)
  • Do not use

    • on damaged or broken skin.

  • When using this product

    • keep out of eyes. Rinse with water to remove • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

  • 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

    • Spray liberally and spread evenly by hand 15 minutes before sun exposure
    • Hold can 4-6 inches away from the skin to apply
    • Do not spray directly into face. Spray into hands then apply to face
    • Do not apply in windy conditions
    • Use in a well-ventilated area.
    • Reapply:

    • after 80 minutes of swimming or sweating

    • immediately after towel drying

    • at least every 2 hours

    • Children under 6 months of age: Ask a doctor
  • Other information

    • protect the product in this container from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Inactive ingredients

    alcohol denat., mineral oil, tridecyl salicylate, fragrance, acrylates/octylacrylamide copolymer, tocopheryl acetate, honey (manuka honey), bertholletia excelsa seed oil (brazil nut), vaccinium macrocarpon (cranberry) seed oil

  • PRINCIPAL DISPLAY PANEL

    83241D1

    83281D1

  • INGREDIENTS AND APPEARANCE
    FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN 
    homosalate, octisalate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    HONEY (UNII: Y9H1V576FH)  
    BRAZIL NUT OIL (UNII: 0G89T29HO6)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-042-37156 g in 1 CAN; Type 0: Not a Combination Product01/15/2019
    2NDC:62217-042-7476.5 g in 1 CAN; Type 0: Not a Combination Product04/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/15/2019
    Labeler - FRUIT OF THE EARTH, INC. (079559467)
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