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

  • NDC Code(s): 62217-350-09, 62217-350-11, 62217-350-16
  • 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 26, 2021

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

View All Sections
  • 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
    • higher SPF gives more sunburn protection
  • 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 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, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, aloe barbadensis leaf juice, anthemis nobilis 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, juglans nigra (black walnut) leaf extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, propylene glycol, potassium cetyl phosphate, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, hydrated silica, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA, fragrance (parfum)

  • PRINCIPAL DISPLAY PANEL

    11350A

    13350A

    18350EF

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  SPORT SPF 50
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    JUGLANS NIGRA LEAF (UNII: I2OQ2W1NI2)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    LEMON PEEL (UNII: 72O054U628)  
    SAGE (UNII: 065C5D077J)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-350-1630 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2016
    2NDC:62217-350-0988 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2016
    3NDC:62217-350-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/20/2016
    Labeler - Fruit of the Earth, Inc. (079559467)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!