Label: FACE VALUES DAILY FACIAL MOISTURIZING SPF 30 SUNSCREEN- homosalate, octinoxate, zinc oxide, octocrylene aerosol, spray

  • NDC Code(s): 63940-062-18, 63940-062-19
  • Packager: HARMON STORES, 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 March 23, 2020

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  • Active ingredients

    Avobenzone 3.0%, Homosalate, 8.0%, Octisalate 4.0%, Octocrylene 8.0%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months of age: ask a doctor
  • Other information

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

    water (purified), niacinamide, glycerin, cetearyl alcohol, cetearyl glucoside, arachidyl alcohol, arachidyl glucoside, aluminum starch octenylsuccinate, boron nitride, dimethicone, ceramide NP, ceramide AP, ceramide EOP, cholesterol, hyaluronic acid, phytophingosine, lecithin, phenoxyethanol, behenyl alcohol, steareth-2, steareth-21, disodium EDTA, sodium lauroyl lactylate, triethoxycaprylylsilane, methylparaben, propylparaben, carbomer, xanthan gum.

  • PRINCIPAL DISPLAY PANEL

    FACE VALUE DAILY FACIAL MOISTURIZING LOTION SPF 30 SUNSCREEN

    3 FL OZ (89mL)

    NDC 63940-062-18

    Label

    FACE VALUE DAILY FACIAL MOISTURIZING LOTION SPF 30 SUNSCREEN

    BLISTER PACK

    NDC 63940-062-19

    Blister Pack

  • INGREDIENTS AND APPEARANCE
    FACE VALUES DAILY FACIAL MOISTURIZING SPF 30 SUNSCREEN 
    homosalate, octinoxate, zinc oxide, octocrylene aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE120 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION35 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-062-191 in 1 CARTON10/27/2017
    1NDC:63940-062-1889 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/27/2017
    Labeler - HARMON STORES, INC. (804085293)
    Registrant - FRUIT OF THE EARTH, INC. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRUIT OF THE EARTH, INC.008193513manufacture(63940-062)
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