Label: LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20 MALVA NUDE/RED- octinoxate and zinc oxide lipstick

  • 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 December 24, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active IngredientsPurpose
    OCTINOXATE 7.5 %Sunscreen
    ZINC OXIDE 3.92 %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

    DIISOPROPYL DIMER DILINOLEATE, ISONONYL ISONONANOATE, OZOKERITE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIDECYL TRIMELLITATE, POLYMETHYLSILSESQUIOXANE, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED POLYCYCLOPENTADIENE, PTFE, BUTYROSPERMUM PARKII (SHEA) BUTTER, TRIDECYL STEARATE, ISODODECANE, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, MICA, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, CETEARYL ETHYLHEXANOATE, METHYLPROPANEDIOL, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, FRAGRANCE, CERAMIDE 3, CAPRYLYL GLYCOL, SILANEDIOL SALICYLATE, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, TROMETHAMINE, SORBITAN ISOSTEARATE, DIMETHICONE, LIMONIUM GERBERI EXTRACT, GRIFOLA FRONDOSA FRUITING BODY EXTRACT, MALTODEXTRIN, PORTULACA PILOSA EXTRACT, TRIMETHYLSILOXYSILICATE, SUCROSE COCOATE, PALMITOYL TRIPEPTIDE-38, BENZYL BENZOATE, AMYL CINNAMAL, HEXYL CINNAMAL, LINALOOL. MAY CONTAIN : TITANIUM DIOXIDE, IRON OXIDES, RED 27 LAKE, RED 21 LAKE, RED 7 LAKE, YELLOW 5 LAKE, RED 30 LAKE, TALC, BLUE 1 LAKE.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Int Ltd.
    DBA Belcorp USA, Miami, FL
    33126

  • PRINCIPAL DISPLAY PANEL

    L'BEL

    CONCENTRÉ
    TOTAL
    LABIOS

    lipstick
    global
    perfection SPF 20

    Net Wt. 0.11 oz. e (3,4 g)

    Concentre lip stick Malva nude

  • INGREDIENTS AND APPEARANCE
    LBEL CONCENTRE TOTAL LABIOS GLOBAL PERFECTION SPF 20  MALVA NUDE/RED
    octinoxate and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0169
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0392 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    MICA (UNII: V8A1AW0880)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0169-21 in 1 BOX10/19/2018
    1NDC:43596-0169-13.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2018
    Labeler - VENTURA CORPORATION LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(43596-0169)
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