{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Softlips Vanilla, Watermelon, Cherry dimethicone, octinoxate, octisalate, oxybenzone CERESIN SQUALANE ETHYLHEXYL PALMITATE PETROLATUM MYRISTYL MYRISTATE MYRISTYL LACTATE CETYL ALCOHOL MYRISTYL LAURATE MYRISTYL ALCOHOL BUTYLATED HYDROXYTOLUENE MENTHOL, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL DIMETHICONE DIMETHICONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE"
      ],
      "active_ingredient": [
        "Active ingredients Dimethicone 2% Octinoxate 7.5% Octisalate 3% Oxybenzone 3%"
      ],
      "purpose": [
        "Purpose Dimethicone - Skin protectant Octinoxate - Sunscreen Octisalate - Sunscreen Oxybenzone - Sunscreen"
      ],
      "indications_and_usage": [
        "Uses helps prevent sunburn temporarily protects chapped or cracked lips"
      ],
      "warnings": [
        "Warnings Skin Cancer/Skin Aging Alert : Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs 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."
      ],
      "do_not_use": [
        "Do not use on damaged or broken skin"
      ],
      "when_using": [
        "When using this product keep out of eyes. Rinse with water to remove."
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs 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 liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information protect this product from excessive heat and direct sun"
      ],
      "inactive_ingredient": [
        "Inactive ingredients ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, 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": [
        "Principal Display Panel Softlips Vanilla, Watermelon, Cherry",
        "Principal Display Panel Drug Facts"
      ],
      "set_id": "2235d029-157e-4a30-be90-605e6bc143fd",
      "id": "2978aff0-b45f-d773-e063-6294a90a4fc1",
      "effective_time": "20241217",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Softlips Vanilla, Watermelon, Cherry"
        ],
        "generic_name": [
          "DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-7009"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE",
          "OCTINOXATE",
          "OCTISALATE",
          "OXYBENZONE"
        ],
        "spl_id": [
          "2978aff0-b45f-d773-e063-6294a90a4fc1"
        ],
        "spl_set_id": [
          "2235d029-157e-4a30-be90-605e6bc143fd"
        ],
        "package_ndc": [
          "10742-7009-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O",
          "4Y5P7MUD51",
          "4X49Y0596W",
          "95OOS7VE0Y"
        ]
      }
    }
  ]
}