{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Baza Protect Zinc Oxide and Dimethicone ZINC OXIDE ZINC OXIDE DIMETHICONE, UNSPECIFIED DIMETHICONE, UNSPECIFIED WATER PETROLATUM LANOLIN OIL PROPYLENE GLYCOL PEG-40 MONOSTEARATE CETYL ALCOHOL PEG-8 MONOSTEARATE GLYCERYL MONOSTEARATE TRICONTANYL POVIDONE CAPRYLYL GLYCOL CAPRYLHYDROXAMIC ACID ETHYLHEXYLGLYCERIN PROPANEDIOL .ALPHA.-TOCOPHEROL ACETATE, DL- EDETIC ACID"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Manufactured by: Coloplast A/S DK-3050 Humlebaek, Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A."
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide, 12% Dimethicone, 1%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps prevent and temporarily protects chafed, chapped or cracked skin. Helps seal out wetness."
      ],
      "warnings": [
        "Warnings For external use only. When using this product Do not get into eyes. Do not use on: deep or puncture wounds animal bites serious burns. 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 this and all drugs 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. Do not use on: deep or puncture wounds animal bites serious burns."
      ],
      "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 this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Apply to affected area and gently wipe with clean, soft cloth. Apply as needed, especially at bedtime or any time when exposure to moisture may be prolonged."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, petrolatum, lanolin oil, propylene glycol, PEG- 40 stearate, cetyl alcohol, PEG-8 stearate, glyceryl stearate, triacontanyl PVP, fragrance, caprylyl glycol, caprylhydroxamic acid, ethylhexylglycerin, propanediol, tocopheryl acetate, EDTA"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 142 g Tube Label NDC 11701-082-24 Baza ® Protect Skin Protectant Moisture Barrier Cream For Skin Irritation Due to Incontinence Coloplast NET WT. 5 OZ. (142 g) PRINCIPAL DISPLAY PANEL - 142 g Tube Label"
      ],
      "set_id": "256dfcfc-a91c-49b0-9439-452586a0880e",
      "id": "7819db44-465c-4283-81fd-5f1bfd6ee11f",
      "effective_time": "20260327",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Baza Protect"
        ],
        "generic_name": [
          "ZINC OXIDE AND DIMETHICONE"
        ],
        "manufacturer_name": [
          "Coloplast Corp"
        ],
        "product_ndc": [
          "11701-082"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "DIMETHICONE, UNSPECIFIED"
        ],
        "rxcui": [
          "637565",
          "1053158"
        ],
        "spl_id": [
          "7819db44-465c-4283-81fd-5f1bfd6ee11f"
        ],
        "spl_set_id": [
          "256dfcfc-a91c-49b0-9439-452586a0880e"
        ],
        "package_ndc": [
          "11701-082-24",
          "11701-082-03",
          "11701-082-22"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}