Label: LBEL PROTEGE EXPERT- ensulizole, octinoxate, octisalate, oxybenzone, and titanium dioxide 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 August 11, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Ensulizole 3%,
    Octinoxate 7.5%,
    Octisalate 5%,
    Oxybenzone 6%,
    Titanium dioxide 3.9%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • Provides high protection against sunburn
    • Retains SPF after 40 minutes of activity in the water
  • Warnings

    For external use only.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally before sun exposure and as needed
  • Other information

    • Sun alert: Limiting sun exposure, waring protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    aqua (water), dicaprylyl carbonate, c12-15 alkyl benzoate, vp/eicosene copolymer, triethanolamine, methyl methacrylate crosspolymer, dimethicone, cyclopentasiloxane, cetearyl alcohol, sorbitan stearate, glyceryl stearate, potassium cetyl phosphate, tocopheryl acetate, cyclohexasiloxane, silica, trimethylsiloxysilicate, phenoxyethanol, methicone, ceteareth-20, methylparaben, xanthan gum, mannitol, parfum (fragrance), propylparaben, butylparaben, ethylparaben, isobutylparaben, arginine, cyclodextrin, dextrin, faex extract (yeast extract), histidine hydrochloride (histidine hci), pisum sativum extract (pisum sativum (pea) extract), acetyltyrosine, disodium succinate, khaya senegalensis bark extract, nicotinamide adenine dinucleotide, pyridoxine hci, aspartic acid.

  • PRINCIPAL DISPLAY PANEL - 50 ml Carton

    L'BEL

    PROTÈGE
    EXPERT

    moisturizing face
    protector lotion
    SPF 40

    loción protectora
    hidratante para rostro
    FPS 40

    WATER RESISTANT
    RESISTENTE AL AGUA

    50 ml e (1.7 fl.oz.)

    UVB SPF
    40
    High Protection

    UVA
    PA + +

    Principal Display Panel - 50 ml Carton
  • INGREDIENTS AND APPEARANCE
    LBEL  PROTEGE EXPERT
    ensulizole, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole.03 g  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate.075 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate.05 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone.06 g  in 1 mL
    Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide.039 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    dicaprylyl carbonate (UNII: 609A3V1SUA)  
    alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)  
    dimethicone (UNII: 92RU3N3Y1O)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    methylparaben (UNII: A2I8C7HI9T)  
    xanthan gum (UNII: TTV12P4NEE)  
    mannitol (UNII: 3OWL53L36A)  
    propylparaben (UNII: Z8IX2SC1OH)  
    butylparaben (UNII: 3QPI1U3FV8)  
    ethylparaben (UNII: 14255EXE39)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    arginine (UNII: 94ZLA3W45F)  
    yeast (UNII: 3NY3SM6B8U)  
    histidine monohydrochloride (UNII: 1D5Q932XM6)  
    pea (UNII: W4X7H8GYFM)  
    sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
    khaya senegalensis bark (UNII: 1S7EDA839L)  
    nadide (UNII: 0U46U6E8UK)  
    pyridoxine hydrochloride (UNII: 68Y4CF58BV)  
    aspartic acid (UNII: 30KYC7MIAI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-027-011 mL in 1 PACKET
    2NDC:13537-027-031 in 1 BOX
    2NDC:13537-027-025 mL in 1 BOTTLE
    3NDC:13537-027-051 in 1 BOX
    3NDC:13537-027-0450 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/10/2011
    Labeler - Ventura Corporation Ltd. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A.880160197MANUFACTURE
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