YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 4-5 (TITANIUM DIOXIDE) POWDER YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 6-7 (TITANIUM DIOXIDE) POWDER YANBAL POLVOS COMPACTOS

YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 4-5 (TITANIUM DIOXIDE) POWDER YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 6-7 (TITANIUM DIOXIDE) POWDER YANBAL POLVOS COMPACTOS
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NDC 23319-0013-1, 23319-0014-1, 23319-0015-1, 23319-0016-1
Set ID 785f2b2e-a523-6278-e053-2991aa0a8f07
Category HUMAN OTC DRUG LABEL
Packager Yanbal USA, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Titanium Dioxide 8.7%

    Purpose: Sunscreen

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  • Uses

    • helps prevent sunburn
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  • 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 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 the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating or immediately after towel drying
    • children under 6 months: Ask a doctor.
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  • Other information

    • protect this product from excessive heat and direct sun
    • report serious adverse event to Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222
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  • Inactive ingredients

    TALC, MICA, SYNTHETIC FLUORPHLOGOPITE, ALUMINUM CALCIUM SODIUM SILICATE, ALUMINUM STARCH OCTENYLSUCCINATE, DIISOPROPYL DIMER DILINOLEATE, NYLON 12, ALUMINUM HYDROXIDE, MAGNESIUM MYRISTATE, ACRYLATE COPOLYMER, HYDROGEN DIMETHICONE, ALUMINA, PHENOXYETHANOL, ETHYLHEXYL PALMITATE, DECYLENE GLYCOL, HYDRATED SILICA, MYRICA PUBESCENS FRUIT WAX, SILICA, LUFFA CYLINDRICA SEED OIL, TIN OXIDE, IRON OXIDES (CI 77491/CI 77492/ CI 77499), TITANIUM DIOXIDE (CI 77891) MANGANESE VIOLET (CI 77742), ULTRAMARINES (CI 77007).

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  • Company information

    Distributed by YANBAL USA INC. 1341 W Newport Center Dr. Deerfield Beach, FL 33442

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  • Product Packaging - Tono 1

    YANBAL

    POLVOS COMPACTOS

    PRESSED POWDER

    SUNSCREEN

    SPF 12

    Net wt. 6.5 g 0.22 oz

    1

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  • Product Packaging - Tono 2-3

    YANBAL

    POLVOS COMPACTOS

    PRESSED POWDER

    SUNSCREEN

    SPF 12

    Net wt. 6.5 g 0.22 oz

    23

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  • Procut Packaging - Tono 4-5

    YANBAL

    POLVOS COMPACTOS

    PRESSED POWDER

    SUNSCREEN

    SPF 12

    Net wt. 6.5 g 0.22 oz

    45

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  • Product Packaging - Tono 6-7

    YANBAL

    POLVOS COMPACTOS

    PRESSED POWDER

    SUNSCREEN

    SPF 12

    Net wt. 6.5 g 0.22 oz

    67

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  • INGREDIENTS AND APPEARANCE
    YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 4-5 
    titanium dioxide powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0015
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 87 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    NYLON-12 (UNII: 446U8J075B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0015-1 1 in 1 CARTON 11/15/2018
    1 6.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 6-7 
    titanium dioxide powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0016
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 87 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NYLON-12 (UNII: 446U8J075B)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0016-1 1 in 1 CARTON 11/15/2018
    1 6.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 1 
    titanium dioxide powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0013
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 87 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NYLON-12 (UNII: 446U8J075B)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0013-1 1 in 1 CARTON 11/15/2018
    1 6.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    YANBAL POLVOS COMPACTOS PRESSED SUNSCREEN SPF 12 TONO 2-3 
    titanium dioxide powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:23319-0014
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 87 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    NYLON-12 (UNII: 446U8J075B)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23319-0014-1 1 in 1 CARTON 11/15/2018
    1 6.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/15/2018
    Labeler - Yanbal USA, Inc. (001801369)
    Establishment
    Name Address ID/FEI Business Operations
    Yanbal de Colombia S.A.S. 880215657 manufacture(23319-0013, 23319-0014, 23319-0015, 23319-0016)
    Establishment
    Name Address ID/FEI Business Operations
    Unique S.A. 934396326 manufacture(23319-0013, 23319-0014, 23319-0015, 23319-0016)
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