Label: LBEL LEDERM 35 PLUS JOUR FACIAL AGAINST FIRST SIGNS OF AGING- avobenzone, octisalate, octocrylene, and oxybenzone lotion

  • 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 November 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone 3%Sunscreen
    Octisalate 5%Sunscreen
    Octocrylene 3%Sunscreen
    Oxybenzone 5%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

    water, c12-15 alkyl benzoate, glyceryl stearate, dimethicone, cyclohexasiloxane, potassium cetyl phosphate, butylene glycol, niacinamide, peg-100 stearate, pentylene glycol, hydrogenated palm glycerides, phenoxyethanol, methyl methacrylate crosspolymer, tocopheryl acetate, xanthan gum, acrylates/c10-30 alkyl acrylate crosspolymer, chlorphenesin, fragrance, acacia senegal gum, sodium hydroxide, disodium edta, hydrolyzed lupine protein, yeast extract, prunus persica (peach) leaf extract, glycerin, ceratonia siliqua (carob) seed extract.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

    • FORMULA CREATED BY FRENCH DERMATOLOGISTS
    SKIN
    EXPERTS

    LEDERM

    35+ JOUR

    facial lotion
    against first
    signs of aging
    day lotion SPF 15
    all skin types

    50 ml e (1.6 fl.oz.)

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    LBEL LEDERM 35 PLUS JOUR FACIAL AGAINST FIRST SIGNS OF AGING 
    avobenzone, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.03 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.05 g  in 1 mL
    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)  
    xanthan gum (UNII: TTV12P4NEE)  
    carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
    chlorphenesin (UNII: I670DAL4SZ)  
    acacia (UNII: 5C5403N26O)  
    sodium hydroxide (UNII: 55X04QC32I)  
    edetate disodium anhydrous (UNII: 8NLQ36F6MM)  
    yeast, unspecified (UNII: 3NY3SM6B8U)  
    prunus persica leaf (UNII: VN3501T41P)  
    glycerin (UNII: PDC6A3C0OX)  
    carob (UNII: 5MG5Z946UO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-995-021 in 1 BOX10/24/2016
    1NDC:13537-995-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/24/2016
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-995)
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