Label: LBEL LEDERM 35PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST FIRST SIGNS OF AGING DAY - NORMAL TO DRY SKIN- avobenzone, octisalate, octocrylene, and oxybenzone cream

  • 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 April 1, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    AVOBENZONE 3.0%Sunscreen
    OCTISALATE 5.0%Sunscreen
    OCTOCRYLENE 3.0%Sunscreen
    OXYBENZONE 5.0%Sunscreen
  • 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), C12-15 ALKYL BENZOATE, GLYCERYL STEARATE, DIMETHICONE, CYCLOHEXASILOXANE, POTASSIUM CETYL PHOSPHATE, BUTYLENE GLYCOL, NIACINAMIDE, PEG-100 STEARATE, PENTYLENE GLYCOL, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TOCOPHERYL ACETATE, SODIUM HYDROXIDE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CHLORPHENESIN, PARFUM (FRAGRANCE), ACACIA SENEGAL GUM, DISODIUM EDTA, HYDROLYZED LUPINE PROTEIN, FAEX EXTRACT (YEAST EXTRACT), PRUNUS PERSICA LEAF EXTRACT (PRUNUS PERSICA (PEACH) LEAF EXTRACT), GLYCERIN, SILICA, CERATONIA SILIQUA SEED EXTRACT (CERATONIA SILIQUA (CAROB) SEED EXTRACT)

  • SPL UNCLASSIFIED SECTION

    P.R.: Distributed
    by Ventura Corporation, Ltd. San Juan,
    Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton

    L'BEL
    LEDERM

    FORMULA CREATED BY FRENCH DERMATOLOGISTS
    SKIN
    EXPERTS

    35+ JOUR

    facial treatment
    against first
    signs of aging
    day cream SPF 15
    normal to dry skin

    50 g e (1.7 oz.)

    Principal Display Panel - 50 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    LBEL LEDERM 35PLUS JOUR   SPF 15 FACIAL TREATMENT AGAINST FIRST SIGNS OF AGING DAY - NORMAL TO DRY SKIN
    avobenzone, octisalate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-445
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.03 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ACACIA (UNII: 5C5403N26O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    YEAST (UNII: 3NY3SM6B8U)  
    PRUNUS PERSICA LEAF (UNII: VN3501T41P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAROB (UNII: 5MG5Z946UO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-445-011 g in 1 PACKET
    2NDC:13537-445-041 in 1 BOX
    2NDC:13537-445-035 g in 1 BOTTLE, PLASTIC
    3NDC:13537-445-061 in 1 BOX
    3NDC:13537-445-0550 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/01/2013
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yobel Supply Chain Management S.A. (Peru)934116930MANUFACTURE(13537-445)
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