Label: LBEL UV DEFENSE 365- homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 25, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Homosalate (5 %)Sunscreen
    Octinoxate (7 %)Sunscreen
    Octisalate (5 %)Sunscreen
    Oxybenzone (4 %)Sunscreen
    Titanium Dioxide (6.24%)Sunscreen
    Zinc Oxide (3.88%)Sunscreen

    Uses

    • Helps prevent sunburn.
    • higher SPF gives more sunburn protection
  • 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 and 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 smoothly every morning before sun exposure and as needed.
  • Other information

    • High sun protection product.
    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
    • Apply the product with your fingertips. Use every morning before exposure to UVA and UVB radiation or whenever needed.
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Corporation, Ltd, San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    L'BEL

    UV DÉFENSE 365

    oil-free daily protective
    facial lotion SPF 50

    UVB SPF 50
    UVA PA +++

    30 ml e (1 fl.oz.)

    Principal Display Panel - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    LBEL UV DEFENSE 365 
    homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.05 g  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.0388 g  in 1 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)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    glycerin (UNII: PDC6A3C0OX)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    ceteareth-12 (UNII: 7V4MR24V5P)  
    cetyl palmitate (UNII: 5ZA2S6B08X)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    propylene glycol (UNII: 6DC9Q167V3)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    methylparaben (UNII: A2I8C7HI9T)  
    ambrosia peruviana leaf (UNII: 458F79CGBF)  
    xanthan gum (UNII: TTV12P4NEE)  
    caprylyl glycol (UNII: 00YIU5438U)  
    mica (UNII: V8A1AW0880)  
    propylparaben (UNII: Z8IX2SC1OH)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    butylene glycol (UNII: 3XUS85K0RA)  
    sunflower seed (UNII: R9N3379M4Z)  
    chlorphenesin (UNII: I670DAL4SZ)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    hedera helix top (UNII: 379040L9FW)  
    phytic acid (UNII: 7IGF0S7R8I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-402-021 in 1 BOX
    1NDC:13537-402-0130 mL in 1 BOTTLE
    2NDC:13537-402-041 in 1 BOX
    2NDC:13537-402-033 mL in 1 BOTTLE
    3NDC:13537-402-051 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/29/2011
    Labeler - Ventura Corporation Ltd. (San Juan, P.R) (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    MF Productions Saumur266769145MANUFACTURE
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