{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "TiZO3 Titanium Dioxide, Zinc Oxide HYDROGEN DIMETHICONE (20 CST) CYCLOHEXASILOXANE DIMETHICONE CROSSPOLYMER TETRAHEXYLDECYL ASCORBATE CYCLOPENTASILOXANE DIMETHICONOL (2000 CST) CI 77499 TITANIUM DIOXIDE TITANIUM DIOXIDE CI 77491 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CI 77492 DIMETHICONE ALPHA-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE LAURYL PEG/PPG-18/18 METHICONE PEG-10 DIMETHICONE (600 CST) ALUMINA"
      ],
      "active_ingredient": [
        "Titanium Dioxide 8% Zinc Oxide 3.8%"
      ],
      "purpose": [
        "Sunscreen"
      ],
      "indications_and_usage": [
        "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. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "dosage_and_administration": [
        "Apply liberally 15 minutes before sun exposure. Use a water-resistant product 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."
      ],
      "inactive_ingredient": [
        "Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate"
      ],
      "other_safety_information": [
        "Protect this product from excessive heat and direct sun May stain some fabrics PA+++"
      ],
      "package_label_principal_display_panel": [
        "Package Label"
      ],
      "set_id": "4e7bdec2-abcc-0267-e063-6394a90ae47a",
      "id": "4e7bdec2-abcd-0267-e063-6394a90ae47a",
      "effective_time": "20260402",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "TiZO3"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Fallien Cosmeceuticals, LTD"
        ],
        "product_ndc": [
          "58892-326"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "4e7bdec2-abcd-0267-e063-6394a90ae47a"
        ],
        "spl_set_id": [
          "4e7bdec2-abcc-0267-e063-6394a90ae47a"
        ],
        "package_ndc": [
          "58892-326-85"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}