Label: LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15- 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 June 22, 2015

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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.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    • 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.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours
    • Children under 6 months of age: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m.–2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    WATER, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, GLYCERIN, POTASSIUM CETYL PHOSPHATE, ALBIZIA JULIBRISSIN BARK EXTRACT, DIMETHICONE, GLYCERYL STEARATE, PENTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, XANTHAN GUM, C20-22 ALKYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, FRAGRANCE, C20-22 ALCOHOLS, CHLORPHENESIN, HYDROLYZED CERATONIA SILIQUA SEED EXTRACT, SODIUM HYDROXIDE, ACACIA SENEGAL GUM, DISODIUM EDTA, OLIVE OIL AMINOPROPANEDIOL ESTERS, RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, HYDROXYPROPYL CYCLODEXTRIN, PALMITOYL TRIPEPTIDE-38.

  • SPL UNCLASSIFIED SECTION

    USA: Dist. by Ventura International Ltd. DBA Belcorp USA,
    San Francisco, CA 94111.

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Box

    • FORMULATED BY FRENCH DERMATOLOGISTS
    SKIN
    EXPERTS

    LEDERM

    DAY LOTION

    SUNSCREEN
    BROAD SPECTRUM
    SPF 15

    day facial lotion
    SPF 15 against
    noticeable signs
    of aging
    normal to oily skin

    50 ml e (1.6 fl.oz.)

    Principal Display Panel - 50 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-803
    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)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    glycerin (UNII: PDC6A3C0OX)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    albizia julibrissin bark (UNII: 0J9G6W44DV)  
    dimethicone (UNII: 92RU3N3Y1O)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    pentylene glycol (UNII: 50C1307PZG)  
    hydrogenated palm glycerides (UNII: YCZ8EM144Q)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    xanthan gum (UNII: TTV12P4NEE)  
    c20-22 alkyl phosphate (UNII: L4VKP0Y7RP)  
    c20-22 alcohols (UNII: O4M0347C6A)  
    chlorphenesin (UNII: I670DAL4SZ)  
    sodium hydroxide (UNII: 55X04QC32I)  
    acacia (UNII: 5C5403N26O)  
    edetate disodium (UNII: 7FLD91C86K)  
    palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-803-021 in 1 BOX
    1NDC:14783-803-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/22/2015
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-803)
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