Label: TITANIUM DIOXIDE- sunscreen cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • Active Ingredients

    Titanium Dioxide 9.90%

  • Purpose

    Suncreen

  • 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

    Shake before use.

    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.

    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, NJ 08536-0222.

  • Inactive Ingredients

    Water/Aqua/Eau, dimethicone, octyldodecyl stearoyl stearate, glycerin, phenyl trimethicone, magnesium sulfate, octyldodecanol, hydrogenated castor oil, cetyl PEG/PPG-10/1 dimethicone, polyglyceryl-3 diisostearate, cetyl dimethicone, disteardimonium hectorite, tremella fuciformis (mushroom) extract, aloe barbadensis leaf juice powder, persea gratissima (avocado) oil, opuntia ficus-indica stem extract, squalane, sodium hyaluronate, glycyrrhiza glabra (licorice) root extract, caprylyl glycol, stearic acid, alumina, potassium sorbate, sodium dehydroacetate, trimethylsiloxysilicate, sodium benzoate, xanthan gum, tocopherol, ethylhexyl palmitate, methicone, butylene glycol, 1,2-hexanediol, trihydroxystearin, sodium hyaluronate, disodium phosphate, ascorbyl palmitate, glucomannan, titanium dioxide (CI 77891), iron oxides (CI 77491, CI 77492, CI 77499), TE111FL000831.

  • Principal Display Panel

    tarte

    high performance naturals

    shape tape

    cloud coverage

    Broad Spectrum

    SPF 15 Sunscreen

    tube001

    box001

  • INGREDIENTS AND APPEARANCE
    TITANIUM DIOXIDE 
    sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66888-341
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE99 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (35/65 W/W; 10000000 PA.S) (UNII: TEU31AO9BN)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SQUALANE (UNII: GW89575KF9)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    WATER (UNII: 059QF0KO0R)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66888-341-011 in 1 CARTON09/24/2021
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/24/2021
    Labeler - Tecnocosmesi S.p.A (435445218)
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