{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "BABY BUM DIAPER Zinc Oxide WATER ZINC OXIDE ZINC OXIDE SYNTHETIC BEESWAX POLYGLYCERYL-3 PENTARICINOLEATE GLYCERYL 1-UNDECYLENATE SORBITAN OLIVATE 1,2-HEXANEDIOL GOAT MILK CETEARYL OLIVATE RICINUS COMMUNIS SEED PROPANEDIOL COPERNICIA CERIFERA (CARNAUBA) WAX HYDROGENATED CASTOR OIL BUTYROSPERMUM PARKII (SHEA) BUTTER CAPRYLHYDROXAMIC ACID C12-15 ALKYL BENZOATE GLYCERYL CAPRYLATE COCOS NUCIFERA (COCONUT) OIL GLYCERYL BEHENATE/EICOSADIOATE HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL ETHYLHEXYLGLYCERIN"
      ],
      "spl_unclassified_section": [
        "Drug Facts .",
        "Other information Store between 68º to 77º F. Do not use if seal is broken."
      ],
      "active_ingredient": [
        "Active Ingredient Zinc Oxide 20.5%"
      ],
      "purpose": [
        "Purpose. ...............Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps prevent and relieve diaper rash. Protects against wetness and irritants."
      ],
      "warnings": [
        "Warnings For external use only. When using this product Avoid contact with eyes. Stop use and contact a doctor if conditions worsen or persist for more than seven days, consult a doctor. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center"
      ],
      "when_using": [
        "When using this product Avoid contact with eyes."
      ],
      "stop_use": [
        "Stop use and contact a doctor if conditions worsen or persist for more than seven days, consult a doctor."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center"
      ],
      "dosage_and_administration": [
        "Directions Change wet and soiled diapers promptly. Cleanse the diaper area thoroughly and allow it to dry. Apply a thick layer of cream to the entire diaper area, especially on areas prone to rash. Use at every diaper change, especially at bedtime or when prolonged exposure to wetness is expected. For best results, use daily to help protect and soothe the skin."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Synthetic Beeswax, C12-15 Alkyl Benzoate, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Water (Aqua), Polyglyceryl-3 Polyricinoleate, Goat Milk, Glyceryl Caprylate, Cetearyl Olivate, Hydrogenated Castor Oil, Sorbitan Olivate, Copernicia Cerifera (Carnauba) Wax, Ethylhexylglycerin, Glyceryl Behenate/ Eicosadioate, Glyceryl Undecylenate, Propanediol, 1,2-Hexanediol, Caprylhydroxamic Acid"
      ],
      "questions": [
        "Questions or comments? Call 1-800-566-7627"
      ],
      "package_label_principal_display_panel": [
        "Dionis Goat Milk Skincare - made with goat milk BABY BUM DIAPER CREAM prevents, treats, and soothes diaper rash safe for sensitive skin pediatrician and dermatologist approved NET WT. 2.5 OZ / 71 G Made for DIONIS® Warrington, PA 18976 (800) 566-7627 MADE IN USA with globally sourced components Label"
      ],
      "set_id": "53d8a654-aaec-6f91-e063-6394a90a7351",
      "id": "53d8a654-aaed-6f91-e063-6394a90a7351",
      "effective_time": "20260609",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "BABY BUM DIAPER"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Creative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare"
        ],
        "product_ndc": [
          "74028-149"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "2623963"
        ],
        "spl_id": [
          "53d8a654-aaed-6f91-e063-6394a90a7351"
        ],
        "spl_set_id": [
          "53d8a654-aaec-6f91-e063-6394a90a7351"
        ],
        "package_ndc": [
          "74028-149-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}