{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Softlips Tropical Coconut dimethicone CERESIN PETROLATUM ETHYLHEXYL PALMITATE SQUALANE OCTYLDODECANOL MYRISTYL MYRISTATE CASTOR OIL MYRISTYL LACTATE CETYL ALCOHOL MYRISTYL LAURATE MYRISTYL ALCOHOL AMMONIUM GLYCYRRHIZATE BUTYLATED HYDROXYTOLUENE LEVOMENTHOL .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE DIMETHICONE"
      ],
      "active_ingredient": [
        "Active ingredients Dimethicone 2%"
      ],
      "purpose": [
        "Purpose Dimethicone - Skin protectant"
      ],
      "indications_and_usage": [
        "Uses helps prevent and temporarily protects chapped or cracked lips helps prevent and 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, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, cetyl alcohol, flavor, myristyl laurate, myristyl alcohol, ammonium glycyrrhizate, BHT, menthol, tocopheryl acetatate [vitamin E]"
      ],
      "questions": [
        "Questions? 1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel Softlips Coconut",
        "Package/Label Principal Display Panel Drug Facts"
      ],
      "set_id": "1203ea70-dc1a-4439-a230-bd3fc45f75f5",
      "id": "2978b416-b2ac-bf49-e063-6394a90a06ae",
      "effective_time": "20241217",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Softlips Tropical Coconut"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-7007"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "spl_id": [
          "2978b416-b2ac-bf49-e063-6394a90a06ae"
        ],
        "spl_set_id": [
          "1203ea70-dc1a-4439-a230-bd3fc45f75f5"
        ],
        "package_ndc": [
          "10742-7007-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}