{
  "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": [
        "Dynashield zinc oxide VITAMIN A ACETATE FD&C YELLOW NO. 5 LAVENDER OIL ALPHA-TOCOPHEROL ALOE VERA LEAF TROLAMINE WATER ZINC OXIDE ZINC OXIDE LANOLIN CETETH-20 MINERAL OIL METHYLPARABEN PROPYLPARABEN GLYCERIN CETYL ALCOHOL CETOSTEARYL ALCOHOL CHOLECALCIFEROL WHITE PETROLATUM"
      ],
      "active_ingredient": [
        "Active Ingredient Zinc Oxide 1.8%"
      ],
      "purpose": [
        "Purpose ​Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps treat and prevent diaper rash. Protects chafed skin associated with diaper rash and helps protect from wetness. Dries the oozing and weeping of poison • ivy • oak • sumac"
      ],
      "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 If pregnant or beast-feeding, ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 7 days or clear up and occur again within a few days"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or beast-feeding, ask a health professional before use"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away"
      ],
      "dosage_and_administration": [
        "Directions For diaper rash: 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. For other uses: Apply as needed."
      ],
      "other_safety_information": [
        "Other Information Store at room temperature 15º-30ºC (59°-86°F) Avoid excessive heat Tamper evident. Do not use if seal is damaged."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Glycerin, Cetostearyl Alcohol, Cetyl Alcohol, White Soft Paraffin, Mineral Oil, Lanolin, Cetomacrogol 1000, Aloe Vera Leaf, Methyl Paraben, Propyl Paraben, Lavander Oil, Alpha Tocopherol, Trolamine, Vitamin A Acetate, Cholecalciferol (Vitamin D3), FD&C Yellow No. 5 (Tartrazine), Water"
      ],
      "package_label_principal_display_panel": [
        "1195 Label 1195 IN MASTER",
        "1196 Label 1196 IN MASTER",
        "Label 1193 1193_BX_MASTER"
      ],
      "set_id": "59fd865c-b81d-43ad-8fa0-c37ca0557769",
      "id": "4e3e4630-9843-775a-e063-6294a90a3ca0",
      "effective_time": "20260330",
      "version": "10",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Dynashield"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Dynarex Corporation"
        ],
        "product_ndc": [
          "67777-407"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1427410"
        ],
        "spl_id": [
          "4e3e4630-9843-775a-e063-6294a90a3ca0"
        ],
        "spl_set_id": [
          "59fd865c-b81d-43ad-8fa0-c37ca0557769"
        ],
        "package_ndc": [
          "67777-407-01",
          "67777-407-02",
          "67777-407-03",
          "67777-407-10",
          "67777-407-04",
          "67777-407-11",
          "67777-407-12",
          "67777-407-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0616784119519",
          "0840117346543",
          "0616784119618"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}