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

  • NDC Code(s): 62217-013-11, 62217-013-15
  • 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.

Drug Label Information

Updated May 23, 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 • 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

    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 a doctor if • rash occurs.

  • 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 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 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, propylene glycol, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), sodium ascorbyl phosphate (vitamin C), calendula officinalis flower extract, symphytum officinale rhizome/root extract, arctium lappa root extract, hydrastis canadensis (golden seal) root extract, honey extract, anthemis nobilis flower extract, tilia cordata flower extract, hydrated silica, potassium cetyl phosphate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA

  • Questions or Comments?

    Call toll free 1-800-527-7731

  • Fruit of the Earth Block Up! Kids SPF 50 Moisturizing Sunscreen Lotion

    Representative Image 6oz

    Representative Image 8oz

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  BLOCK UP KIDS SPF 50 MOISTURIZING SUNSCREEN
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-013
    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
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    HONEY (UNII: Y9H1V576FH)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    TILIA CORDATA WHOLE (UNII: W5E5UB44GD)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-013-15177 mL in 1 TUBE; Type 0: Not a Combination Product05/23/2017
    2NDC:62217-013-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/23/2017
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-013)