{
  "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": [
        "Dynashield with Dimethicone zinc oxide DIMETHICONE DIMETHICONE WHITE PETROLATUM METHYLPARABEN VITAMIN A ACETATE LAVENDER OIL LANOLIN CETETH-20 MINERAL OIL PROPYLPARABEN GLYCERIN CETYL ALCOHOL CETOSTEARYL ALCOHOL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALOE VERA LEAF FD&C YELLOW NO. 5 TROLAMINE WATER ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide 2% Dimethicone 1.8%"
      ],
      "purpose": [
        "Purpose Diaper rash Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses • Temporarily protects and relieves chafed or cracked skin • Helps treat and prevent diaper rash. Protects minor skin irritations associated with diaper rash and helps seal out wetness. • Dries the oozing and weeping of poison • ivy • oak • sumac"
      ],
      "warnings": [
        "Warnings For External Use Only Stop use and ask a doctor if • Condition wosens • Symptoms last more than 7 days or clear up and occur again within a few days If pregnant or breast-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"
      ],
      "stop_use": [
        "Stop use and ask a doctor if • Condition wosens • Symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-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."
      ],
      "spl_unclassified_section": [
        "Other information • Store at room temperature between 15 0 - 30 0 C (59 0 - 86 0 F) • Avoid excessive heat • Tamper evident. Do not use if seal is damaged."
      ],
      "inactive_ingredient": [
        "Inactive ingredients aloe vera leaf, alpha-tocopherol (vitamin E), cetomacrogol-20, cetostearyl alcohol, cetyl alcohol, glycerin, lanolin, lavender oil, methylparaben, mineral oil, propylparaben, trolamine, vitamin A acetate, vitamin D3, water, white soft paraffin"
      ],
      "questions": [
        "Questions and Comments? 1-888-Dynarex Monday - Friday, 9AM-5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Label DynaShield with Dimehticone 1199 IN MASTER",
        "Label 1198 1198_BX_MASTER"
      ],
      "set_id": "b5dcf9e8-4689-4a08-ae73-3a859b4cbffe",
      "id": "4df28dab-75de-50c0-e063-6394a90adbbc",
      "effective_time": "20260326",
      "version": "8",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Dynashield with Dimethicone"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Dynarex Corporation"
        ],
        "product_ndc": [
          "67777-408"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "2644139"
        ],
        "spl_id": [
          "4df28dab-75de-50c0-e063-6394a90adbbc"
        ],
        "spl_set_id": [
          "b5dcf9e8-4689-4a08-ae73-3a859b4cbffe"
        ],
        "package_ndc": [
          "67777-408-03",
          "67777-408-02",
          "67777-408-05",
          "67777-408-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0616784119915",
          "0840117346567"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}