Label: TARTEGUARD 20 TINTED MOISTURIZER LIGHT- titanium dioxide and zinc oxide liquid
TARTEGUARD 20 TINTED MOISTURIZER LIGHT-MEDIUM- titanium dioxide and zinc oxide liquid
TARTEGUARD 20 TINTED MOISTURIZER MEDIUM- titanium dioxide and zinc oxide liquid

  • NDC Code(s): 51060-114-01, 51060-115-01, 51060-116-01
  • Packager: Tarte, Inc
  • Category: HUMAN OTC DRUG LABEL

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 11, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 5%Sunscreen
    Zinc Oxide 5%Sunscreen
  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only.

    Stop use and ask doctor if rash occurs.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months: Ask a doctor.
    • Optional: apply to all skin exposed to the sun.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      –
      Limit time in the sun, especially from 10 a.m.-2 p.m.
      –
      Wear long-sleeved shirts, pants, hats and sunglasses
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
    • You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.
  • Inactive ingredients

    Water, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, octyldodecyl neopentanoate, glycerin, dimethicone, aluminum hydroxide, stearic acid, phenoxyethanol, mica, boron nitride, sodium dehydroacetate, caprylyl glycol, sodium chloride, phytantriol, kaolin, magnesium ascorbyl phosphate, palmitic acid, dextrin palmitate, sodium hyaluronate, hexylene glycol, retinyl palmitate, tocopheryl acetate, tocopherol, tetrahexyldecyl ascorbate, methicone, butylene glycol, triethoxycaprylylsilane, calcium sodium phosphosilicate, saccharum officinarum (sugar cane) extract, pyrus malus (apple) fruit extract, citrus limon (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, camellia oleifera leaf extract, panax ginseng root extract, ginkgo biloba leaf extract, anthemis nobilis flower extract, iron oxides.

  • SPL UNCLASSIFIED SECTION

    Dist. by tarte™,
    Inc. New York, NY 10018.

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - light

    tarte
    high-performance naturals™

    TARTEGUARD
    20

    tinted moisturizer
    Broad Spectrum
    SPF 20 Sunscreen

    net 50 mL / 1.7 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - light
  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - light-medium

    tarte
    high-performance naturals™

    TARTEGUARD
    20

    tinted moisturizer
    Broad Spectrum
    SPF 20 Sunscreen

    net 50 mL / 1.7 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - light-medium
  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - medium

    tarte
    high-performance naturals™

    TARTEGUARD
    20

    tinted moisturizer
    Broad Spectrum
    SPF 20 Sunscreen

    net 50 mL / 1.7 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - medium
  • INGREDIENTS AND APPEARANCE
    TARTEGUARD 20 TINTED MOISTURIZER   LIGHT
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    glycerin (UNII: PDC6A3C0OX)  
    dimethicone (UNII: 92RU3N3Y1O)  
    aluminum hydroxide (UNII: 5QB0T2IUN0)  
    stearic acid (UNII: 4ELV7Z65AP)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    mica (UNII: V8A1AW0880)  
    boron nitride (UNII: 2U4T60A6YD)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    caprylyl glycol (UNII: 00YIU5438U)  
    sodium chloride (UNII: 451W47IQ8X)  
    phytantriol (UNII: 8LVI07A72W)  
    kaolin (UNII: 24H4NWX5CO)  
    magnesium ascorbyl phosphate (UNII: 0R822556M5)  
    palmitic acid (UNII: 2V16EO95H1)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    hexylene glycol (UNII: KEH0A3F75J)  
    vitamin A palmitate (UNII: 1D1K0N0VVC)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    tocopherol (UNII: R0ZB2556P8)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    methicone (20 cst) (UNII: 6777U11MKT)  
    butylene glycol (UNII: 3XUS85K0RA)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    sugarcane (UNII: 81H2R5AOH3)  
    apple (UNII: B423VGH5S9)  
    lemon (UNII: 24RS0A988O)  
    orange (UNII: 5EVU04N5QU)  
    camellia oleifera leaf (UNII: 5077EL0C60)  
    asian ginseng (UNII: CUQ3A77YXI)  
    ginkgo (UNII: 19FUJ2C58T)  
    chamaemelum nobile flower (UNII: O2T154T6OG)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-114-011 in 1 CARTON04/01/2017
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/01/2017
    TARTEGUARD 20 TINTED MOISTURIZER   LIGHT-MEDIUM
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    glycerin (UNII: PDC6A3C0OX)  
    dimethicone (UNII: 92RU3N3Y1O)  
    aluminum hydroxide (UNII: 5QB0T2IUN0)  
    stearic acid (UNII: 4ELV7Z65AP)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    mica (UNII: V8A1AW0880)  
    boron nitride (UNII: 2U4T60A6YD)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    caprylyl glycol (UNII: 00YIU5438U)  
    sodium chloride (UNII: 451W47IQ8X)  
    phytantriol (UNII: 8LVI07A72W)  
    kaolin (UNII: 24H4NWX5CO)  
    magnesium ascorbyl phosphate (UNII: 0R822556M5)  
    palmitic acid (UNII: 2V16EO95H1)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    hexylene glycol (UNII: KEH0A3F75J)  
    vitamin A palmitate (UNII: 1D1K0N0VVC)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    tocopherol (UNII: R0ZB2556P8)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    methicone (20 cst) (UNII: 6777U11MKT)  
    butylene glycol (UNII: 3XUS85K0RA)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    sugarcane (UNII: 81H2R5AOH3)  
    apple (UNII: B423VGH5S9)  
    lemon (UNII: 24RS0A988O)  
    orange (UNII: 5EVU04N5QU)  
    camellia oleifera leaf (UNII: 5077EL0C60)  
    asian ginseng (UNII: CUQ3A77YXI)  
    ginkgo (UNII: 19FUJ2C58T)  
    chamaemelum nobile flower (UNII: O2T154T6OG)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-115-011 in 1 CARTON04/01/2017
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/01/2017
    TARTEGUARD 20 TINTED MOISTURIZER   MEDIUM
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    glycerin (UNII: PDC6A3C0OX)  
    dimethicone (UNII: 92RU3N3Y1O)  
    aluminum hydroxide (UNII: 5QB0T2IUN0)  
    stearic acid (UNII: 4ELV7Z65AP)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    mica (UNII: V8A1AW0880)  
    boron nitride (UNII: 2U4T60A6YD)  
    sodium dehydroacetate (UNII: 8W46YN971G)  
    caprylyl glycol (UNII: 00YIU5438U)  
    sodium chloride (UNII: 451W47IQ8X)  
    phytantriol (UNII: 8LVI07A72W)  
    kaolin (UNII: 24H4NWX5CO)  
    magnesium ascorbyl phosphate (UNII: 0R822556M5)  
    palmitic acid (UNII: 2V16EO95H1)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    hexylene glycol (UNII: KEH0A3F75J)  
    vitamin A palmitate (UNII: 1D1K0N0VVC)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    tocopherol (UNII: R0ZB2556P8)  
    tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)  
    methicone (20 cst) (UNII: 6777U11MKT)  
    butylene glycol (UNII: 3XUS85K0RA)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    sugarcane (UNII: 81H2R5AOH3)  
    apple (UNII: B423VGH5S9)  
    lemon (UNII: 24RS0A988O)  
    orange (UNII: 5EVU04N5QU)  
    camellia oleifera leaf (UNII: 5077EL0C60)  
    asian ginseng (UNII: CUQ3A77YXI)  
    ginkgo (UNII: 19FUJ2C58T)  
    chamaemelum nobile flower (UNII: O2T154T6OG)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-116-011 in 1 CARTON04/01/2017
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/01/2017
    Labeler - Tarte, Inc (027905186)
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