Label: MATTE PRO DEFENSE BASE MATE CON MULTIPROTECCION DE LA PIEL FPS 20 MATTE FOUNDATION WITH SKIN MULTIPROTECTION SPF 20 MOKACCINO 390-N- zinc oxide,octinoxate 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 April 30, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    OCTINOXATE 5.00% Sunscreen

    ZINC OXIDE 4.20% Sunscreen

  • PURPOSE

    Uses
    Helps prevent sunburn.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information
    Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive ingredients: WATER, DIMETHICONE, ISODODECANE, PEG-10 DIMETHICONE, TRIMETHYLSILOXYSILICATE, PROPYLENE GLYCOL, MICA, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-18/18 DIMETHICONE, POLYSILICONE-11, GLYCERIN, LECITHIN, SODIUM CHLORIDE, PHENOXYETHANOL, SILICA, SILICA DIMETHYL SILYLATE, BACKHOUSIA CITRIODORA LEAF EXTRACT, MALTODEXTRIN, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, HYDROXYETHYL UREA, PEG-8 CAPRYLIC/CAPRIC GLYCERIDES, CHLORPHENESIN, TOCOPHERYL ACETATE, LACTOBACILLUS FERMENT, OCTYLDODECETH-25, PERFLUOROOCTYL TRIETHOXYSILANE, SODIUM HYALURONATE, DECYLENE GLYCOL.

    MAY CONTAIN :
    TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE.

  • 390-N

    L'BEL

    MATTE PRO DEFENSE
    Base Mate con multiproteccion de la piel FPS 20
    Matte foundation with skin multiprotection SPF 20
    1.01 fl. oz. (30ml)
    Tone MOKACCINO 390-N

    Mokaccino 390-N

  • INGREDIENTS AND APPEARANCE
    MATTE PRO DEFENSE BASE MATE CON MULTIPROTECCION DE LA PIEL FPS 20 MATTE FOUNDATION WITH SKIN MULTIPROTECTION SPF 20 MOKACCINO 390-N 
    zinc oxide,octinoxate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MICA (UNII: V8A1AW0880)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    OCTYLDODECETH-25 (UNII: F8934HEL3M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    BACKHOUSIA CITRIODORA LEAF (UNII: FKN73KG747)  
    PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    WATER (UNII: 059QF0KO0R)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0213-130 mL in 1 JAR; Type 0: Not a Combination Product04/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/14/2021
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197manufacture(43596-0213)
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