Label: FRUIT OF THE EARTH BLOCK UP SPF 70 GENERAL PROTECTION SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

  • NDC Code(s): 62217-020-22
  • 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 February 7, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients

    Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

  • 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, butylene glycol, microcrystalline cellulose, glyceryl stearate, behenyl alcohol, benzyl alcohol, diethylhexyl syringylidene malonate, aloe barbadensis leaf juice, tocopherol (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, stearic acid, palmitic acid, lauryl alcohol, myristyl alcohol, cetyl alcohol, lecithin, caprylic/capric triglyceride, chlorphenesin, cellulose gum, butylated PVP, N-vinylpyrrolidone, 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 70 General Protection Sunscreen Lotion

    Label1Label2

  • INGREDIENTS AND APPEARANCE
    FRUIT OF THE EARTH  BLOCK UP SPF 70 GENERAL PROTECTION SUNSCREEN
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DOCOSANOL (UNII: 9G1OE216XY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CUCUMBER (UNII: YY7C30VXJT)  
    EUPHRASIA STRICTA (UNII: C9642I91WL)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62217-020-22177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/07/2018
    Labeler - Fruit of the Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(62217-020)