Label: POWDER- zinc oxide, titanium dioxide powder

  • 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 February 10, 2023

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  • Active ingredients

    Titanium Dioxide 8.6%

    Zinc Oxide 10.0%

  • Purpose

    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 again caused by the sun.
  • Warnings

    For external use only

  • Stop Use

    Stop use and ask doctor if rash occurs

  • Do not use

    Do not use on damaged or broken skin

  • When using

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

  • Keep out of the reach of children

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

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at lease 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 sin increases your risk ofg 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-2p.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.

  • Primary package

    61354-052-02_AW8g 61354-052-02

  • Secondary Package

    61354-052-02_AW8g 61354-052-02

  • INGREDIENTS AND APPEARANCE
    POWDER 
    zinc oxide, titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.6 mg  in 100 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-052-021 in 1 CARTON02/25/2021
    18 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/25/2021
    Labeler - Oxygen development (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development137098492manufacture(61354-052)
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