Label: FRUIT OF THE EARTH VITAMIN E SPF 15 SUNSCREEN DAILY DEFENSE MOISTURIZER- avobenzone, octinoxate, octocrylene, oxybenzone lotion

  • NDC Code(s): 62217-252-33
  • Packager: FRUIT OF THE EARTH, INC.
  • 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 February 21, 2023

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  • Active ingredients

    Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

  • 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.

    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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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

    water, aloe barbadensis leaf juice, c12-15 alkyl benzoate, cyclopentasiloxane, phenyl trimethicone, acrylates copolymer, propylene glycol, stearic acid, glyceryl stearate, PEG 100 stearate, tocopheryl acetate (vitamin E), acrylates/steareth-20 methacrylate copolymer, triethanolamine, citrus limon (lemon) fruit oil, methylparaben, propylparaben, ethylparaben, butylparaben, phenoxyethanol, isobutylparaben, disodium EDTA, fragrance, titanium dioxide.

  • Label

    960E2

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH VITAMIN E SPF 15 SUNSCREEN DAILY DEFENSE MOISTURIZER 
    avobenzone, octinoxate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-252
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
    LEMON OIL (UNII: I9GRO824LL)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-252-33118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02006/13/2005
    Labeler - FRUIT OF THE EARTH, INC. (079559467)
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