{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "MUSTELA Diaper Rash 1 2 3 ZINC OXIDE ZINC OXIDE ZINC OXIDE SUNFLOWER OIL LEVULINIC ACID MAGNESIUM SULFATE, UNSPECIFIED FORM AVOCADO AVOCADO OIL POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE POLYGLYCERYL-3 DIISOSTEARATE PROPYLENE CARBONATE SODIUM LEVULINATE STEARALKONIUM HECTORITE 4,4-DIMETHYLOXAZOLIDINE WATER YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES CAPRYLOYL GLYCINE CAPRYLYL GLYCOL COCO-CAPRYLATE/CAPRATE ETHYL LINOLEATE GLYCERIN"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information Protect this product from excessive heat and direct sun. May stain some fabrics and surfaces."
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 9.9%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps treat and prevent diaper rash Protects minor skin irritation associated with diaper rash and helps seal out wetness"
      ],
      "warnings": [
        "Warnings For external use only. When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Polyglyceryl-2-Dipolyhydroxystearate, Glycerin, Beeswax, Persea Gratissima (Avocado) Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Ethyl Linoleate, Persea Gratissima (Avocado) Fruit Extract, Magnesium Sulfate, Stearalkonium Hectorite, Levulinic Acid, Caprylyl Glycol, Capryloyl Glycine, Sodium Levulinate, Undecyl Dimethyl Oxazoline, Propylene Carbonate"
      ],
      "questions": [
        "Questions or comments? Call 1-800-422-2987 M-F 9:00AM-5:00PM EST"
      ],
      "package_label_principal_display_panel": [
        "Product Packaging 64768-2292-1 5"
      ],
      "set_id": "59cf1d1e-e951-9d58-e063-6394a90af0f3",
      "id": "59cf1e54-e721-a471-e063-6294a90a3a72",
      "effective_time": "20260824",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "MUSTELA Diaper Rash 1 2 3"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Expanscience Laboratories d/b/a Mustela"
        ],
        "product_ndc": [
          "64768-2292"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "2106103"
        ],
        "spl_id": [
          "59cf1e54-e721-a471-e063-6294a90a3a72"
        ],
        "spl_set_id": [
          "59cf1d1e-e951-9d58-e063-6394a90af0f3"
        ],
        "package_ndc": [
          "64768-2292-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}