Label: FRUIT OF THE EARTH BLOCK UP SPF 30 SUNSCREEN- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotion

  • NDC Code(s): 62217-021-09
  • 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 June 2, 2017

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  • Active ingredients

    Avobenzone 2.0%, 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

  • 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, 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, hydrated silica, potassium cetyl phosphate,
    propylene glycol, phenoxyethanol (and) methylparaben (and) propylparaben (and)
    butylparaben (and) ethylparaben (and) isobutylparaben, acrylates/C10-30 alkyl acrylate
    crosspolymer, disodium EDTA, fragrance (parfum)

  • Fruit of the Earth, Inc. Block Up! SPF 30 Sunscreen Lotion

    Representative Image

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  BLOCK UP SPF 30 SUNSCREEN
    avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    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
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CUCUMBER (UNII: YY7C30VXJT)  
    EUPHRASIA STRICTA (UNII: C9642I91WL)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-021-0988 mL in 1 TUBE; Type 0: Not a Combination Product06/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/02/2017
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-021)
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