Label: LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50- homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 28, 2012

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  • L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50


  • Active Ingredients

    Homosalate (5%)
    Octinoxate (7.0%)
    Octisalate (5.0%)
    Oxybenzone (4.0%)
    Titanium Dioxide (6.24%)
    Zinc Oxide (3.92%)

  • Uses

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

  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor.
  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    Aqua (Water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis0ethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, silica, methicone, peg-8, ceteareth-12, ceteareth-20, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, cetearyl alcohol, cetyl palmitate, xanthan gum, caprylyl glycol, mica, propylparaben, butylene glycol, helianthus annuus seed extract (helianthus annuus (sunflower) seed extract), ppg-1-peg-9-lauryl glycol ether, chlorophenesin, triethoxycaprylylsilane, cyclopentasiloxane, hedera helix leaf/stem extract (hedera helix (ivy) leaf/stem extract), phytic acid, sodium polyacrylate.

  • Purpose

    Sunscreen
  • PRINCIPAL DISPLAY PANEL

    L'BEL  DEFENSE 365 oil-free protective facial lotion SPF 50   30ml e (1 fl. oz.)

    US: Dist. by Ventural Internationa Ltd.  DBA Bellcorp USA, San Francisco, CA 94111

    P.R. Dist. by Ventura Corporation Ltd., San Juan, Puerto Rico 00926  MADE IN FRANCE



  • L'BEL DEFENSE 365 Oil-Free Daily Protective Facial Lotion SPF 50


    Defense36530 ml Inner

    Defense 36530 ml Outer

  • INGREDIENTS AND APPEARANCE
    LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 
    homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43455-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.24 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.92 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ALCOHOL (UNII: 3K9958V90M)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMBROSIA PERUVIANA LEAF (UNII: 458F79CGBF)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MICA (UNII: V8A1AW0880)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43455-0001-01 mL in 1 POUCH
    2NDC:43455-0001-13 mL in 1 TUBE
    3NDC:43455-0001-230 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/28/2012
    Labeler - Ventura International, LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    MF Productions266769145manufacture
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