{
  "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": [
        "ClaraVie Zinc Oxide ZINC OXIDE ZINC OXIDE .ALPHA.-TOCOPHEROL, D- CETOSTEARYL ALCOHOL CETYL ALCOHOL CHOLECALCIFEROL GLYCERIN LANOLIN MINERAL OIL FRAGRANCE LAVENDER ORC1800979 PARAFFIN PHENOXYETHANOL SODIUM BENZOATE ALOE VERA LEAF CETETH-20 WATER FD&C YELLOW NO. 5 MICROCRYSTALLINE WAX BEESWAX PROPYLENE GLYCOL"
      ],
      "active_ingredient": [
        "Zinc Oxide 3.8% w/w"
      ],
      "keep_out_of_reach_of_children": [
        "If swallowed, get medical help or contact a Poison Control Center right away"
      ],
      "purpose": [
        "Skin Protectant"
      ],
      "inactive_ingredient": [
        "Aloe Barbadendis Gel, Alpha Tocopherol, Cetomacrogol 1000, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, DM Water, Glycerin, Lanolin, Lavendor, Mineral Oil, Parrafin, Phenoxyethanol, Propylene Glycol, Sodium Benzoate, Vitamin D , FD&C Yellow No.5, Microcrystalline Wax, Beeswax"
      ],
      "warnings": [
        "When using this product Do not get into eyes"
      ],
      "ask_doctor": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again in a few days"
      ],
      "indications_and_usage": [
        "Helps treat and prevent undergarment rash Temporarily protects minor cuts ,scrapes , burns , dries the oozing and weeping of poison ivy , poison oak , poison sumac"
      ],
      "dosage_and_administration": [
        "Topical"
      ],
      "questions": [
        "Store at room temperature 59-86 0 F ( 15-30 0 C). Avoid excessive heat"
      ],
      "package_label_principal_display_panel": [
        "Test"
      ],
      "set_id": "596abd98-17d7-2a22-e063-6294a90af57d",
      "id": "596abd98-17d8-2a22-e063-6294a90af57d",
      "effective_time": "20260819",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "ClaraVie"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Gentell LLC"
        ],
        "product_ndc": [
          "61554-302"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "596abd98-17d8-2a22-e063-6294a90af57d"
        ],
        "spl_set_id": [
          "596abd98-17d7-2a22-e063-6294a90af57d"
        ],
        "package_ndc": [
          "61554-302-11"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}