{
  "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": [
        "Softlips Vanilla dimethicone CASTOR OIL MYRISTYL LACTATE CETYL ALCOHOL CERESIN PETROLATUM ETHYLHEXYL PALMITATE OCTYLDODECANOL SQUALANE MYRISTYL MYRISTATE MYRISTYL LAURATE MYRISTYL ALCOHOL BUTYLATED HYDROXYTOLUENE MENTHOL, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL DIMETHICONE DIMETHICONE"
      ],
      "active_ingredient": [
        "Active ingredient Dimethicone 2%"
      ],
      "purpose": [
        "Purpose Dimethicone - Skin protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects and helps relieve chapped or cracked lips helps protect from the drying effects of wind and cold weather"
      ],
      "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"
      ],
      "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"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions apply as needed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients ozokerite, petrolatum, ethylhexyl palmitate, octyldodecanol, squalane, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, flavor, menthol, tocopheryl acetatate [vitamin E]"
      ],
      "questions": [
        "Questions? 1-877-636-2677 MON-FRI 9AM to 5PM (EST)"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel Softlips Vanilla",
        "Package/Label Principal Display Panel Drug Facts"
      ],
      "set_id": "56551008-a4e0-406f-8403-980d2e6b75a0",
      "id": "4dbef1d2-0153-3eaa-e063-6294a90a0cbc",
      "effective_time": "20260324",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Softlips Vanilla"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8508"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "spl_id": [
          "4dbef1d2-0153-3eaa-e063-6294a90a0cbc"
        ],
        "spl_set_id": [
          "56551008-a4e0-406f-8403-980d2e6b75a0"
        ],
        "package_ndc": [
          "10742-8508-1",
          "10742-8508-2"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}