Label: CREAM- zinc oxide, titanium dioxide lotion

  • NDC Code(s): 61354-082-01
  • Packager: Oxygen Development LLC
  • 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 August 27, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Titanium Dioxide 4.55%

    Zinc Oxide 3.5%

  • 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 aging caused by the sun.

  • Warnings

    For external use only. Stop use and ask a doctor if rash occurs. Do not use on damage or broken skin.

  • When using this product

    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 the 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

    Cyclopentasiloxane, Isododecane, Polysilicone-11, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder

  • Package Label

    61354-082-01_aw61354-081-01_aw

  • INGREDIENTS AND APPEARANCE
    CREAM 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.54 mg  in 100 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.49 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 55.74 mg  in 100 mg
    ISODODECANE (UNII: A8289P68Y2) 10.69 mg  in 100 mg
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 4.68 mg  in 100 mg
    HEXYL LAURATE (UNII: 4CG9F9W01Q) 1.76 mg  in 100 mg
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) 3.19 mg  in 100 mg
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) 1.5 mg  in 100 mg
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) 1.65 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-082-011 in 1 CARTON08/26/2022
    1100 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/26/2022
    Labeler - Oxygen Development LLC (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development LLC137098492manufacture(61354-082)