Label: LBEL DERMO CLARITE BRIGHTENING AND MOISTURIZING FACIAL SPF 30- avobenzone, octisalate, 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 November 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone 1.80 %Sunscreen
    Octisalate 4.50 %Sunscreen
    Octocrylene 4.50 %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, GLYCERIN, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, CYCLOHEXASILOXANE, ETHYLHEXYL METHOXYCRYLENE, POTASSIUM CETYL PHOSPHATE, TRIETHYLHEXANOIN, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE, PEG-100 STEARATE, SYNTHETIC FLUORPHLOGOPITE, HYDROXYACETOPHENONE, TITANIUM DIOXIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, VIGNA ACONITIFOLIA SEED EXTRACT, XANTHAN GUM, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, DIMETHYLMETHOXY CHROMANYL PALMITATE, CETEARYL ISONONANOATE, SODIUM COCOYL GLUTAMATE, ACACIA SENEGAL GUM, TETRASODIUM EDTA, CETEARETH-20, CETEARYL ALCOHOL, SODIUM HYDROXIDE, HYDROLYZED ALGIN, CETEARETH-12, CETYL PALMITATE, PHENOXYETHANOL, TIN OXIDE

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton

    L'BEL

    DERMO
    CLARITÉ

    brightening and
    moisturizing facial
    lotion SPF 30

    30 ml e (1 fl.oz.)

    PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton
  • INGREDIENTS AND APPEARANCE
    LBEL DERMO CLARITE BRIGHTENING AND MOISTURIZING FACIAL SPF 30 
    avobenzone, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0088
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.018 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.045 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.045 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    ACACIA (UNII: 5C5403N26O)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0088-21 in 1 BOX08/08/2018
    1NDC:43596-0088-130 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/08/2018
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(43596-0088)
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