FRUIT OF THE EARTH BLOCK UP SPF 30 GENERAL PROTECTION SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]

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  • FRUIT OF THE EARTH BLOCK UP SPF 30 GENERAL PROTECTION SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]

FRUIT OF THE EARTH BLOCK UP SPF 30 GENERAL PROTECTION SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [FRUIT OF THE EARTH, INC.]
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NDC 62217-019-11
Set ID 505ace8b-824a-098a-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Fruit of the Earth, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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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
    • 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 doctor if​

    • rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    ​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 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

  • Inactive ingredients

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

  • Other information

    • protect this product from excessive heat and direct sun

    • may stain or damage some fabrics, materials or surfaces

  • Questions or comments?

    Call toll free 1-800-527-7731

  • Fruit of the Earth Block Up! SPF 30 General Protection Sunscreen Lotion

    Representative Image

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  BLOCK UP SPF 30 GENERAL PROTECTION SUNSCREEN
    avobenzone, octinoxate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-019
    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
    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)  
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-019-11237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/25/2017
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-019)
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