Label: POWDER- titanium dioxide powder

  • NDC Code(s): 61354-119-01, 61354-119-02
  • Packager: Oxygen Development LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • Active Ingredient

    Titanium Dioxide

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn.

  • Warnings

    For external use only

  • 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 reach of children

    • Keep out of 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

  • Other Information

    Protect this product from excessive heat and direct sun • In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

  • Inactive Ingredient

    Mica, Caprylic/Capric Triglyceride, Boron Nitride, Bismuth Oxychloride, Zinc Stearate, Magnesium Silicate, Sodium Starch Octenylsuccinate, Mannitol, Sodium Gluconate, Citric Acid, Sodium Citrate, Waltheria Indica Leaf Extract, Dextrin, Ferulic Acid, Lactic Acid (L), Butyrospermum Parkii (Shea) Butter, Retinol, Ceramide AP, Silica, Tocopheryl Acetate, Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Magnesium Carbonate, Iron Oxides (CI 77491, CI 77492, CI 77499), May Contain: Titanium Dioxide (CI 77891), Ultramarines (CI 77007).

  • Package label - Principal display panel

    61354-119-01-aw61354-119-02_aw61354-119-01_aw

  • INGREDIENTS AND APPEARANCE
    POWDER 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED1.75 mg  in 100 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 8 mg  in 100 mg
    MAGNESIUM SILICATE (UNII: 9B9691B2N9) 2 mg  in 100 mg
    MANNITOL (UNII: 3OWL53L36A) 1.67 mg  in 100 mg
    BORON NITRIDE (UNII: 2U4T60A6YD) 8 mg  in 100 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.5 mg  in 100 mg
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) 1.89 mg  in 100 mg
    MICA (UNII: V8A1AW0880) 47.33 mg  in 100 mg
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) 10 mg  in 100 mg
    ZINC STEARATE (UNII: H92E6QA4FV) 2.8 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61354-119-021 in 1 CARTON10/27/2023
    1NDC:61354-119-01100 mg in 1 CUP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/27/2023
    Labeler - Oxygen Development LLC (137098492)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxygen Development LLC137098492manufacture(61354-119)
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