Label: DAILY SPF 15- avobenzone, octinoxate, octisalate lotion

  • 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 May 4, 2020

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  • Active ingredients

    Avobenzone 3.0%, Octinoxate 7.5%, Octisalate 2.0%

  • Purpose

    Sunscreen

  • INDICATIONS & USAGE

    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

    • on damaged or broken skin.
  • When using this product

    • keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if

    • rash occurs.
  • 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 at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • children under 6 months of age: ask a doctor
    • 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
  • Other information

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

    water, C12-15 alkyl benzoate, cetearyl alcohol, glycerin, aloe barbadensis leaf juice, dimethicone, glycine soja (soybean) seed extract, phenyl trimethicone, arachidyl alcohol, cetearyl glucoside, phenoxyethanol, benzyl alcohol, panthenol, ethylene/ acrylic acid copolymer, behenyl alcohol, steareth-2, steareth-21, polymethyl methacrylate, polyacrylamide, arachidyl glucoside, disodium EDTA, C13-14 isoparaffin, laureth-7, silica, benzlkonium chloride, iodopropynyl butylcarbamate, PEG-4, PEG-4 laurate, alcohol, BHT, sodium hydroxide, citric acid, mica, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    KROGER BROMLEY'S FOR MEN DAILY SPF 15 MOISTURIZER

    Label

  • INGREDIENTS AND APPEARANCE
    DAILY SPF 15 
    avobenzone, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-879
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DOCOSANOL (UNII: 9G1OE216XY)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    GLYCOL DILAURATE (UNII: 9O691KKR2A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-879-13120 mL in 1 TUBE; Type 0: Not a Combination Product06/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/07/2018
    Labeler - THE KROGER CO (006999528)
    Registrant - Fruit Of The Earth, Inc. (079559467)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit Of The Earth, Inc.080086802manufacture(30142-879)
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