Label: FRUIT OF THE EARTH BLOCK UP SPORT SPF 50 SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

  • NDC Code(s): 62217-024-09, 62217-024-11
  • 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 August 28, 2017

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  • 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

  • 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), anthemis nobilis flower extract (and) citrus medica limonum (lemon) peel extract (and) geranium maculatum extract (and) calendula officinalis flower extract (and) salvia officinalis (sage) leaf extract (and) arctium lappa root extract (and) melissa officinalis root extract (and) juglans nigra (black walnut), propylene glycol, potassium cetyl phosphate, phenoxyethanol (and) methylparaben (and) propylparaben (and) butylparaben (and) ethylparaben (and) isobutylparaben, hydrated silica, acrylates C/10-30 alkyl acrylate crosspolymer, disodium EDTA, fragrance (parfum)

  • Fruit of the Earth, Inc. Block Up! Sport SPF 50 Sunscreen Lotion

    Representative Image

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  BLOCK UP SPORT SPF 50 SUNSCREEN
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-024
    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
    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)  
    LEMON PEEL (UNII: 72O054U628)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    BLACK WALNUT (UNII: 02WM57RXZJ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    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)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SAGE (UNII: 065C5D077J)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-024-0988 mL in 1 TUBE; Type 0: Not a Combination Product06/02/2017
    2NDC:62217-024-11237 mL in 1 BOTTLE; 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(62217-024)
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