Label: FRUIT OF THE EARTH BLOCK UP BROAD SPECTRUM SPORT SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

  • NDC Code(s): 62217-186-12
  • Packager: FRUIT OF THE EARTH, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2024

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  • Active ingredients

    Avobenzone 2.0%, Homosalate 9.0%, Octinoxate 7.5%, Octisalate 5.0%, Octocrylene 1.5%, Oxybenzone 5.0%

  • Purpose

    Sunscreen

  • Uses

    • 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 doctor

    if rash occurs.

  • Keep out of reach of children.

    If product is 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: 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

    water (aqua), C12-15 alkyl benzoate, PEG-8, acrylates/C12-22 alkyl methacrylate copolymer, cetearyl alcohol,
    dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), sodium ascorbyl
    phosphate (vitamin C), chamomilla recutita (matricaria) flower extract, citrus limon (lemon) peel extract, geranium
    maculatum extract, calendula officinalis flower extract, salvia officinalis (sage) leaf extract, arctium lappa root
    extract, melissa officinalis leaf extract, propylene glycol, potassium cetyl phosphate, phenoxyethanol,
    methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, hydrated silica, acrylates/C10-30
    alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)

  • Label

    28350E2F2

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH BLOCK UP  BROAD SPECTRUM SPORT SPF 50
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-186
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETEARETH-10 PHOSPHATE (UNII: 099WOY1SA3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    CHAMOMILE (UNII: FGL3685T2X)  
    LEMON PEEL (UNII: 72O054U628)  
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SAGE (UNII: 065C5D077J)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-186-12237 mL in 1 TUBE; Type 0: Not a Combination Product08/24/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/24/201107/07/2025
    Labeler - FRUIT OF THE EARTH, INC. (079559467)
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