Label: SEA SET AND PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TRANSLUCENT- titanium dioxide and zinc oxide powder
SEA SET AND PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TRANSLUCENT DEEP- titanium dioxide and zinc oxide powder

  • NDC Code(s): 51060-236-01, 51060-237-01
  • Packager: Tarte, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 8.6%Sunscreen
    Zinc Oxide 10.0%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

    Polymethylsilsesquioxane, silica, jojoba esters, caprylyl glycol, alumina, sodium dehydroacetate, phenoxyethanol, vanillin, caprylic/capric triglyceride, hexylene glycol, vanilla planifolia fruit extract, aluminum dimyristate, triethoxycaprylylsilane, disodium stearoyl glutamate, mica, iron oxides. OX100FW000041.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 8 g Tube Carton - translucent

    tarte™
    SEA

    set & protect

    mineral powder
    sunscreen
    Broad Spectrum SPF 30

    net wt 8 g / 0.28 Oz.

    PRINCIPAL DISPLAY PANEL - 8 g Tube Carton - translucent
  • PRINCIPAL DISPLAY PANEL - 8 g Tube Carton - translucent deep

    tarte™

    SEA

    set & protect
    mineral powder sunscreen
    Broad Spectrum SPF 30

    net wt 8 g / 0.28 Oz.

    PRINCIPAL DISPLAY PANEL - 8 g Tube Carton - translucent deep
  • INGREDIENTS AND APPEARANCE
    SEA SET AND PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30   TRANSLUCENT
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide86 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VANILLIN (UNII: CHI530446X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    VANILLA BEAN (UNII: Q74T35078H)  
    ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-236-011 in 1 CARTON03/05/2020
    18 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02003/05/2020
    SEA SET AND PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30   TRANSLUCENT DEEP
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51060-237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide86 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    VANILLIN (UNII: CHI530446X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    VANILLA BEAN (UNII: Q74T35078H)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51060-237-011 in 1 CARTON03/05/2020
    18 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02003/05/2020
    Labeler - Tarte, Inc. (027905186)
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