Label: LBEL LEDERM 55PLUS JOUR SPF 15 FACIAL TREATMENT AGAINST ADVANCED SIGNS OF AGING DAY - ALL SKIN TYPES- 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 Ingredients Purpose
    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), GLYCERIN, C12-15 ALKYL BENZOATE, DIMETHICONE, DICAPRYLYL CARBONATE, PHENETHYL BENZOATE, CYCLOPENTASILOXANE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, CYCLOHEXASILOXANE, PENTYLENE GLYCOL, TRILAURETH-4 PHOSPHATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED PALM GLYCERIDES, METHYL METHACRYLATE CROSSPOLYMER, PHENOXYETHANOL, CETYL ALCOHOL, GLYCERYL STEARATE, ALBIZIA JULIBRISSIN BARK EXTRACT, BIS-VINYL DIMETHICONE/DIMETHICONE COPOLYMER, PEG-75 STEARATE, XANTHAN GUM, CETEARETH-20, CHLORPHENESIN, PARFUM (FRAGRANCE), ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CETETH-20, STEARETH-20, TETRASODIUM EDTA, ACACIA SENEGAL GUM, CICHORIUM INTYBUS ROOT EXTRACT (CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT), ALARIA ESCULENTA EXTRACT, SODIUM HYDROXIDE, ALCOHOL, LECITHIN, HYDROLYZED SOYBEAN FIBER, HYDROXYPROPYL CYCLODEXTRIN, FOLIC ACID, HYDROLYZED CORN PROTEIN, PALMITOYL TRIPEPTIDE-38

  • 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 FRNECH DERMATOLOGISTS
    SKIN
    EXPERTS

    55+ JOUR

    facial treatment
    against advanced
    signs of aging
    day cream SPF 15
    all skin types

    50 g e (1.7 oz.)

    Principal Display Panel - 50 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    LBEL LEDERM 55PLUS JOUR   SPF 15 FACIAL TREATMENT AGAINST ADVANCED SIGNS OF AGING DAY - ALL SKIN TYPES
    avobenzone, octisalate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-448
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ACACIA (UNII: 5C5403N26O)  
    CHICORY ROOT (UNII: 090CTY533N)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    FOLIC ACID (UNII: 935E97BOY8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-448-011 g in 1 PACKET
    2NDC:13537-448-041 in 1 BOX
    2NDC:13537-448-035 g in 1 BOTTLE, PLASTIC
    3NDC:13537-448-061 in 1 BOX
    3NDC:13537-448-0550 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(13537-448)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yobel Supply Chain Management S.A. (Peru)934116930MANUFACTURE(13537-448)
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