FRUIT OF THE EARTH SPF 50 MOISTURIZING SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]

FRUIT OF THE EARTH SPF 50 MOISTURIZING SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]
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NDC 62217-008-03
Set ID 4fa45b28-c0be-1880-e054-00144ff8d46c
Generic Name
Product Class
Product Number
Application Number PART352
  • 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

    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
    • 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 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-sleeve shirts, pants, hats, and sunglasses

    • 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, calendula officinalis flower extract, symphytum officinale rhizome/root extract, arctium lappa root extract, honey extract, anthemis nobilis flower extract, tilia cordata flower extract, dicetyl phosphate, ceteth-10 phosphate, tocopheryl acetate, sodium ascorbyl phosphate, hydrated silica, potassium cetyl phosphate, propylene glycol, phenoxyethanol, potassium sorbate, caprylyl glycol, hexylene
    glycol, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA

  • Questions or comment?

    Call toll free 1-800-527-7731

  • Fruit of the Earth, Inc. Kids SPF 50 Moisturizing Sunscreen Lotion

    Representative Image

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  SPF 50 MOISTURIZING SUNSCREEN
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-008
    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
    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
    Inactive Ingredients
    Ingredient NameStrength
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HONEY (UNII: Y9H1V576FH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-008-0388 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(62217-008)

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