{
  "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": [
        "Cover Creme Titanium Dioxide TITANIUM DIOXIDE TITANIUM DIOXIDE MINERAL OIL KAOLIN BARIUM SULFATE MAGNESIUM CARBONATE CARNAUBA WAX STEARIC ACID PHENOXYETHANOL TRIETHOXYCAPRYLYLSILANE CAPRYLYL GLYCOL LAUROYL LYSINE ALLANTOIN SYNTHETIC BEESWAX SILICA DIMETHYL SILYLATE ALUMINUM HYDROXIDE MICROCRYSTALLINE WAX MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) ISOPROPYL PALMITATE TOCOPHEROL"
      ],
      "active_ingredient": [
        "Active Ingredient Titanium Dioxide 5.81%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses 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 Do not use on damaged or broken skin. When using this product When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor Stop use and ask a doctor if rash occurs. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Cneter right away."
      ],
      "do_not_use": [
        "Do not use Do not use on damaged or broken skin."
      ],
      "when_using": [
        "When using this product When using this product keep out of eyes. Rinse with water to remove."
      ],
      "stop_use": [
        "Stop use and ask a doctor Stop use and ask a doctor if rash occurs."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Cneter right away."
      ],
      "dosage_and_administration": [
        "Directions For sunscreen use, apply liberally 15 minutes before sun exposure; reapply at least every 2 hours; use a water resistant sunscreen if swimming or sweating. Sun Protection Measures Spending time n the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrun SPF value of 15 or higher and other sun protection measures including; limit time in the sun, especially from 10a.m.-2p.m.; wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age. Ask a doctor."
      ],
      "other_safety_information": [
        "Sun Protection Measures Spending time n the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrun SPF value of 15 or higher and other sun protection measures including; limit time in the sun, especially from 10a.m.-2p.m.; wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age. Ask a doctor."
      ],
      "storage_and_handling": [
        "Other information Protect the product in this container from excessive heat and direct sun"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Inactive ingredients mineral oil (paraffinum liquidum), zea mays (corn) starch, synthetic beeswax, kaolin, barium sulfate, isopropyl plamitate, magnesium carbonate, copernicia cerifera (carnauba) wax, aluminum hydroxide, microcrystalline wax (cera microcristallina), stearic acid, phenoxyethanol, triethoxycaprylylsilane, caprylyl glycol, lauroyl lysine, allantoin, silica silylate, tocopherol. may contain: iron oxides, titanium dioxide"
      ],
      "questions": [
        "Questions or comments? 1-800-662-8011"
      ],
      "package_label_principal_display_panel": [
        "cover creme"
      ],
      "set_id": "31f5e8c4-523f-4596-e063-6294a90a6a12",
      "id": "57f4c026-ee78-8280-e063-6294a90a911b",
      "effective_time": "20260731",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Cover Creme"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "Baxter of California"
        ],
        "product_ndc": [
          "84203-005"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "57f4c026-ee78-8280-e063-6294a90a911b"
        ],
        "spl_set_id": [
          "31f5e8c4-523f-4596-e063-6294a90a6a12"
        ],
        "package_ndc": [
          "84203-005-01",
          "84203-005-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15FIX9V2JP"
        ]
      }
    }
  ]
}