{
  "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": "2026-10-02",
    "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 You may report serious side effects to the phone number provided below or to Expanscience Laboratories Inc. dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022, USA. PE plastic tube ensures proper product conservation and facilitates daily use.",
        "Company information Distributed in USA by Expanscience Laboratories dba Mustela, New York, NY 10022, USA"
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 9.9 %"
      ],
      "purpose": [
        "Purpose skin protectant"
      ],
      "indications_and_usage": [
        "Uses Helps treat and prevent diaper rash Protects chafed skin associated with diaper rash 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 seven days symptoms 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 right away."
      ],
      "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 seven days symptoms 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 right away."
      ],
      "dosage_and_administration": [
        "Directions Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally and as often as necessary and 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 toll free 1-800-422-2987 Monday-Friday 9:00am-5:00pm EST"
      ],
      "package_label_principal_display_panel": [
        "Product Packaging 1"
      ],
      "set_id": "163f388e-849d-4b7e-93c1-9045d77a9ec2",
      "id": "5995d8e5-7e8b-eec5-e063-6394a90ab31b",
      "effective_time": "20260821",
      "version": "9",
      "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": [
          "64768-2922"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "2106103"
        ],
        "spl_id": [
          "5995d8e5-7e8b-eec5-e063-6394a90ab31b"
        ],
        "spl_set_id": [
          "163f388e-849d-4b7e-93c1-9045d77a9ec2"
        ],
        "package_ndc": [
          "64768-2922-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}