Label: FRUIT OF THE EARTH BLOCK UP BROAD SPECTRUM BABY SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion

  • NDC Code(s): 62217-174-05
  • Packager: Fruit of the Earth, Inc.
  • Category: HUMAN OTC DRUG LABEL

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.

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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
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

  • Do not use on

    damaged or broken skin.

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Stop use and ask doctor

    if rash occurs.

  • Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center 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

    • 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 value 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-sleeved shirts, pants, hats, and sunglasses

    • children under 6 months: Ask a doctor
  • Inactive ingredients

    water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl
    methacrylate copolymer, propylene glycol, aloe barbadensis leaf juice, tocopheryl acetate (vitamin
    E), sodium ascorbyl phosphate (vitamin C), dicetyl phosphate, ceteth-10 phosphate, potassium
    cetyl phosphate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben,
    isobutylparaben, hydrated silica, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA,
    triethanolamine, fragrance (parfum)

  • Other information

    • protect the product in this container from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces

  • Label

    28150E1F2

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH BLOCK UP  BROAD SPECTRUM BABY SPF 50
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-174
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-174-05237 mL in 1 TUBE; Type 0: Not a Combination Product08/24/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/24/2011
    Labeler - Fruit of the Earth, Inc. (079559467)
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