Label: LBEL DEFENSE TOTAL BROAD SPECTRUM SPF 50 PLUS SUNSCREEN FOR FACE AND BODY- avobenzone, homosalate, and octocrylene 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 May 22, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone 3.00%Sunscreen
    Homosalate 10.00%Sunscreen
    Octocrylene 8.00%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.
    • Reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • 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, BUTYLOCTYL SALICYLATE, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, POLYMETHYLSILSESQUIOXANE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, ETHYLHEXYL METHOXYCRYLENE, PHENETHYL BENZOATE, PROPYLENE GLYCOL, VP/EICOSENE COPOLYMER, SILICA, TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CETYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, FRAGRANCE, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CITRIC ACID, OXOTHIAZOLIDINE.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 10 ml Bottle Carton

    L'BEL
    DÉFENSE
    TOTAL

    HIGH PROTECTION
    SPF
    50+

    broad spectrum
    sunscreen
    lotion for face
    and body

    WITH COLLAGEN
    BIO-PROTECTORS

    WATER RESISTANT
    (40 minutes)

    10 ml e (.33 fl.oz.)

    Principal Display Panel - 10 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    LBEL DEFENSE TOTAL BROAD SPECTRUM SPF 50 PLUS SUNSCREEN FOR FACE AND BODY 
    avobenzone, homosalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-383
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.1 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.08 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-383-0180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:14783-383-031 in 1 BOX
    2NDC:14783-383-0210 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:14783-383-051 in 1 PACKAGE
    3NDC:14783-383-041 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35205/22/2015
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-383)
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