{
  "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 Peppermint Swirl dimethicone BUTYLATED HYDROXYTOLUENE ETHYLHEXYL PALMITATE CETYL ALCOHOL SQUALANE AMMONIUM GLYCYRRHIZATE PETROLATUM MYRISTYL LACTATE ALPHA-TOCOPHEROL ACETATE CERESIN RICINUS COMMUNIS (CASTOR) SEED OIL MYRISTYL LAURATE OCTYLDODECANOL MYRISTYL MYRISTATE DIMETHICONE DIMETHICONE MYRISTYL ALCOHOL MENTHOL"
      ],
      "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 Keep 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"
      ],
      "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, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, ammonium glycyrrhizate, BHT, menthol, tocopheryl acetate [vitamin E]"
      ],
      "questions": [
        "Questions? 1-877-636-2677 MON-FRI 9AM to 5PM (EST)"
      ],
      "package_label_principal_display_panel": [
        "Package Label/Principal Display Panel Image 1",
        "Package Label/Principal Display Panel Image 2"
      ],
      "set_id": "4dbea50e-d82d-c702-e063-6394a90ac6e4",
      "id": "4dbea50e-d82e-c702-e063-6394a90ac6e4",
      "effective_time": "20260324",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Softlips Peppermint Swirl"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8518"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "spl_id": [
          "4dbea50e-d82e-c702-e063-6394a90ac6e4"
        ],
        "spl_set_id": [
          "4dbea50e-d82d-c702-e063-6394a90ac6e4"
        ],
        "package_ndc": [
          "10742-8518-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310742010336"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}