Label: LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30- avobenzone, octisalate, octocrylene emulsion

  • 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 7, 2023

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  • Drug Facts

  • Active Ingredients

    Avobenzone 1.80%

    Octisalate 4.50%

    Octocrylene 4.50%

  • 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 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, cetearyl isononanoate, sodium cocoyl glutamate, acacia senegal gum, dimethylmethoxy chromanyl palmitate, tetrasodium edta, ceteareth-20, cetearyl alcohol, sodium hydroxide, hydrolyzed algin, ceteareth-12, cetyl palmitate, phenoxyethanol, tin oxide.

  • Company Information

    PUERTO RICO: Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926, U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126 .

    www.lbel.com

  • Package Label

    1

  • INGREDIENTS AND APPEARANCE
    LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30 
    avobenzone, octisalate, octocrylene emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE18 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    MOTH BEAN (UNII: H7938ON8E5)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    STANNOUS OXIDE (UNII: JB2MV9I3LS)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ACACIA (UNII: 5C5403N26O)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14141-332-011 in 1 BOX06/20/2023
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02006/20/2023
    Labeler - BEL STAR SA (880160197)
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