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LBEL UV DEFENSE 365 (Ventura Corporation Ltd. (San Juan, P.R))

Available Formats

Dosage Form Package Information Links
LOTION 1 mL in 1 PACKET (13537-402-05) Label Information
LOTION 1 BOTTLE in 1 BOX (13537-402-04) > 3 mL in 1 BOTTLE (13537-402-03) Label Information
LOTION 1 BOTTLE in 1 BOX (13537-402-02) > 30 mL in 1 BOTTLE (13537-402-01) Label Information

Complete LBEL UV DEFENSE 365 Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    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 Type HUMAN OTC DRUG Item Code (Source) NDC:13537-402
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.05 g  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.04 g  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0624 g  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.0388 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13537-402-02 1 in 1 BOX
    1 NDC:13537-402-01 30 mL in 1 BOTTLE
    2 NDC:13537-402-04 1 in 1 BOX
    2 NDC:13537-402-03 3 mL in 1 BOTTLE
    3 NDC:13537-402-05 1 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/29/2011
    Labeler - Ventura Corporation Ltd. (San Juan, P.R) (602751344)
    Establishment
    Name Address ID/FEI Business Operations
    MF Productions Saumur 266769145 MANUFACTURE