Label: FRUIT OF THE EARTH SUN TOWN CITY SPF 30 SUNSCREEN- avobenzone, homosalate, octocrylene spray

  • NDC Code(s): 62217-068-37, 62217-068-74
  • 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

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

  • Active Ingredients

    Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

  • Purpose

    Sunscreen

  • Uses

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

  • Warnings

    For external use only

  • 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 incerate. Contents under pressures. • do not store at temperatures above 120°F.

  • Stop use and ask a doctor if

    • 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
    • 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 othe rsun protection measures including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

  • 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., isododecane, diisopropyl adipate, acrylates/octylacrylamide copolymer, VA/butyl maleate/isobornyl acrylate copolymer, PEG-12 dimethicone, caprylyl glycol, hydrogenated methyl abietate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract, fragrance.

  • PRINCIPAL DISPLAY PANEL

    83660D

    83662D

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH SUN TOWN CITY SPF 30 SUNSCREEN 
    avobenzone, homosalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALCOHOL (UNII: 3K9958V90M)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYL HYDROGENATED ROSINATE (UNII: 13DHA19W9N)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-068-7476.5 g in 1 CAN; Type 0: Not a Combination Product11/26/2019
    2NDC:62217-068-37156 g in 1 CAN; Type 0: Not a Combination Product11/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/26/2019
    Labeler - Fruit of the Earth, Inc. (079559467)