FRUIT OF THE EARTH BLOCK UP SPF 4 DARK TANNING (OCTINOXATE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]

FRUIT OF THE EARTH BLOCK UP SPF 4 DARK TANNING (OCTINOXATE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]
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NDC 62217-025-03
Set ID 5164f929-d0c9-4cc6-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Fruit of the Earth, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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

  • WHEN USING

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

  • STOP USE

    Stop use and ask doctor if​ rash or irritation develops and lasts

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously and evenly before sun exposure and as needed.
    • reapply as needed or after towel drying, swimming, or perspiring.
    • children under 6 months of age: ask a doctor
  • Other information

    • may stain some fabrics
    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of aging, skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    water (aqua), C12-15 alkyl benzoate, PEG-8, acrylates /C12-22 alkyl methacrylate copolymer, cetearyl alcohol (and) dicetyl phosphate (and) ceteth-10 phosphate, aloe barbadensis leaf juice, acrylates/C10-30 alkyl acrylate crosspolymer, daucus carota sativa (carrot) root extract, tocopheryl acetate (vitamin E), retinyl palmitate (vitamin A), sodium ascorbyl phosphate (vitamin C), arnica montana flower extract (and) chamomilla recutita (matricaria) flower extract (and) geranium maculatum extract (and) cucumis sativus (cucumber) fruit extract (and) euphrasia officinalis extract (and) tilia cordata flower extract (and) althaea officinalis root extract (and) yucca schidigera extract, potassium cetyl phosphate, propylene glycol, hydrated silica, phenoxyethanol (and) methylparaben (and) propylparaben (and) butylparaben (and) ethylparaben (and) isobutylparaben, disodium EDTA, fragrance (parfum)

  • Fruit of the Earth, Inc. Block Up! SPF 4 Dark Tanning Lotion

    Representative Image

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  BLOCK UP SPF 4 DARK TANNING
    octinoxate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-025
    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)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    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)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-025-0388 mL in 1 TUBE; Type 0: Not a Combination Product06/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/07/2017
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-025)

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