Label: FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 30, 2020

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  • Active ingredients

    Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection mesaures (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.

  • ASK DOCTOR

    Stop use and ask a 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, espcially 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, glycerin, polyester-7, neopentyl glycol diheptanoate, aluminum starch octenylsuccinate, silica, styrene/acrylates copolymer, phenoxyethanol, isododecane, arachidyl alcohol, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance

  • Questions or comments?

    1-800-527-7731

  • PRINCIPAL DISPLAY PANEL

    FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN LOTION

    3 FL OZ (88.7mL)

    NDC 63940-068-09

    Label

  • INGREDIENTS AND APPEARANCE
    FACE VALUES ULTRA SPORT ACTIVE SPF 50 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISODODECANE (UNII: A8289P68Y2)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-068-0988.7 mL in 1 TUBE; Type 0: Not a Combination Product04/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/06/2017
    Labeler - HARMON STORES, INC. (804085293)
    Registrant - FRUIT OF THE EARTH, INC. (008193513)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRUIT OF THE EARTH, INC.079559467manufacture(63940-068)