{
  "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 CYCLOPENTASILOXANE ALPHA-TOCOPHEROL ACETATE TITANIUM DIOXIDE TITANIUM DIOXIDE ALUMINA PEG-10 DIMETHICONE (600 CST) TETRAHEXYLDECYL ASCORBATE LAURYL PEG/PPG-18/18 METHICONE DIMETHICONE CROSSPOLYMER CI 77492 CI 77499 ZINC OXIDE ZINC OXIDE DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CI 77491 HYDROGEN DIMETHICONE (20 CST) CYCLOHEXASILOXANE DIMETHICONOL (2000 CST)"
      ],
      "active_ingredient": [
        "Titanium Dioxide 8% Zinc Oxide 3.8%"
      ],
      "purpose": [
        "Sunscreen"
      ],
      "indications_and_usage": [
        "Helps prevent sunburn."
      ],
      "warnings": [
        "For external use only."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Apply liberally 15 minutes before sun exposure."
      ],
      "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"
      ],
      "package_label_principal_display_panel": [
        "Package Label"
      ],
      "set_id": "468d6476-127a-e9f0-e063-6294a90a3df9",
      "id": "468d6476-127b-e9f0-e063-6294a90a3df9",
      "effective_time": "20251222",
      "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": [
          "468d6476-127b-e9f0-e063-6294a90a3df9"
        ],
        "spl_set_id": [
          "468d6476-127a-e9f0-e063-6294a90a3df9"
        ],
        "package_ndc": [
          "58892-326-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}