Label: CREAM- titanium dioxide cream

  • NDC Code(s): 61354-080-04, 61354-080-10
  • 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 February 10, 2023

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  • Active Ingredient

    Titanium Dioxide 17%. Purpose: Sunscreen

  • Purpose

    Sunscreen

  • Uses

    helps prevent sunburn if used as directed with other sun protection measures. Decreased the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    for external use only

  • Do not use

    on damaged or broken skin

  • When using

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

  • Stop use

    and ask a doctor if rash occurs

  • Keep out of reach of children

    If product is swallowed, get medical help or contact a poison control center right away

  • Directions

    for sunscreen 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 of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10am - 2pm
    • wear long-slevve shirts, pants, hats, and sunglasses
  • Inactive ingredients

    isododecane, disteardimonium hectorite, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, propylene carbonate, silica, Trimethylsiloxysilicate, Dipalmitoyl Hydroxyproline, Mangifera Indica (Mango) Seed Butter, Carthamus Tinctorius (Safflower) Seed Oil, Camellia Oleifera Leaf Extract, Acrylates Copolymer, Diacetyl Boldine, Calcium Sodium Borosilicate, Calcium Aluminum Borosilicate, tin oxide, phenoxyethanol, may contain: mica, carmine, titanium dioxide, iron oxides, Bismuth Oxychloride,chromium hydroxide green, chromium oxide greens, ferric fenocyanide, manganese violet, ultramarines

  • other information

    protect this product from excessive heat and direct sun

  • package label

    61354-080-10_AW

  • INGREDIENTS AND APPEARANCE
    CREAM 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE17 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
    MANGO SEED OIL (UNII: K8LOR30915)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-080-101 in 1 CARTON02/22/202102/10/2023
    1NDC:61354-080-043 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/22/2021
    Labeler - Oxygen Development LLC (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development LLC137098492manufacture(61354-080)
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