Label: LBEL DERMO CLARITE- avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL

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 29, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Butyl methoxydibenzoylmethane 3.0%,

    Ensulizole 3.0%,

    Octisalate 5.0%,

    Octocrylene 5.0%,

    Oxybenzone 6.0%

  • Purpose

    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 damage 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.
    • Children under 6 months of age: Ask a doctor
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
  • Other information

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

    aqua (water), dicaprylyl carbonate, cetearyl alcohol, phenethyl benzoate, triethanolamine, cyclopentasiloxane, propylene glycol, methyl methacrylate crosspolymer, sorbitan stearate, triethylhexanoin, potassium cetyl phosphate, phenoxyethanol, dimethicone, stearyl dimethicone, ceteareth-20, xanthan gum, chlorphenesin, parfum (fragrance), vigna aconitifolia seed extract, cetyl alcohol, dimethylmethoxy chromanyl palmitate, glyceryl stearate, methylparaben, sodium cocoyl glutamate, tetrasodium edta, peg-75 stearate, butylparaben, sorbic acid, ceteth-20, steareth-20.

  • SPL UNCLASSIFIED SECTION

    US: Distributed by Ventura International Ltd,
    San Francisco, CA 94111.

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

    L'BEL
    DERMO CLARITÉ

    clarifying and moisturizing
    facial lotion with SPF 30

    30 ml e (1 fl.oz.)

    Principal Display Panel - 30 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    LBEL   DERMO CLARITE
    avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-434
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 g  in 1 mL
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.03 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.05 g  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.06 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    dicaprylyl carbonate (UNII: 609A3V1SUA)  
    alcohol (UNII: 3K9958V90M)  
    phenethyl benzoate (UNII: 0C143929GK)  
    trolamine (UNII: 9O3K93S3TK)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    triethylhexanoin (UNII: 7K3W1BIU6K)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    dimethicone (UNII: 92RU3N3Y1O)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    xanthan gum (UNII: TTV12P4NEE)  
    chlorphenesin (UNII: I670DAL4SZ)  
    moth bean (UNII: H7938ON8E5)  
    cetyl alcohol (UNII: 936JST6JCN)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    methylparaben (UNII: A2I8C7HI9T)  
    edetate sodium (UNII: MP1J8420LU)  
    peg-75 stearate (UNII: OT38R0N74H)  
    butylparaben (UNII: 3QPI1U3FV8)  
    sorbic acid (UNII: X045WJ989B)  
    ceteth-20 (UNII: I835H2IHHX)  
    steareth-20 (UNII: L0Q8IK9E08)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-434-011 in 1 BOX
    1NDC:14783-434-0230 mL in 1 BOTTLE
    2NDC:14783-434-041 in 1 BOX
    23 mL in 1 BOTTLE
    3NDC:14783-434-051 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/26/2011
    Labeler - Ventura International Ltd. (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star, S. A.(Colombia)880160197MANUFACTURE(14783-434)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yobel Supply Chain Management (Peru)934116930MANUFACTURE(14783-434)
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