FRUIT OF THE EARTH SPF 4 MOISTURIZING TANNING SUNSCREEN (OCTINOXATE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]

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  • FRUIT OF THE EARTH SPF 4 MOISTURIZING TANNING SUNSCREEN (OCTINOXATE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]

FRUIT OF THE EARTH SPF 4 MOISTURIZING TANNING SUNSCREEN (OCTINOXATE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]
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NDC 62217-011-03
Set ID 4fa6437a-8aaf-67be-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Fruit of the Earth, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Octinoxate 2.0%, Oxybenzone 0.5%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn • higher SPF gives more sunburn protection

  • Warnings

    ​For external use only

  • DO NOT USE

    Do not use • on damaged or broken skin.

  • WHEN USING

    ​When using this product​ keep out of eyes. Rinse with water to remove.

  • STOP USE

    ​Stop use and ask doctor if​

    • rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children. ​If product is swallowed, get medical help right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor
  • Other information

    • protect this product 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, daucus corota sativa (carrot) root extract, arnica montana flower extract, chamomilla recutita (matricaria) flower extract, germanium maculatum extract, cucumis sativus (cucumber) fruit extract, euphrasia officinalis extract, tilia cordata flower extract, althaea officinalis extract, yucca schidigera extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, potassium cetyl phosphate, propylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, hydrated silica, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene glycol, triethanolamine, disodium EDTA, fragrance (parfum)

  • Questions or comment?

    Call toll free 1-800-527-7731

  • Fruit of the Earth, Inc. SPF 4 Moisturizing Tanning Sunscreen Lotion

    Representative Image

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  SPF 4 MOISTURIZING TANNING SUNSCREEN
    octinoxate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE20 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARROT (UNII: L56Z1JK48B)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    EUPHRASIA STRICTA (UNII: C9642I91WL)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-011-0388 mL in 1 TUBE; Type 0: Not a Combination Product05/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/16/2017
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-011)
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