{
  "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 Peppermint 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 ACETATE 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 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 Do not use on damaged or broken skin 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"
      ],
      "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."
      ],
      "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 acetate [vitamin E]"
      ],
      "questions": [
        "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel Softlips Peppermint",
        "Principal Display Panel Drug Facts"
      ],
      "set_id": "1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27",
      "id": "2979d22f-8814-978d-e063-6394a90a9131",
      "effective_time": "20241217",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Softlips Peppermint"
        ],
        "generic_name": [
          "DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8517"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE",
          "OCTINOXATE",
          "OCTISALATE",
          "OXYBENZONE"
        ],
        "spl_id": [
          "2979d22f-8814-978d-e063-6394a90a9131"
        ],
        "spl_set_id": [
          "1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27"
        ],
        "package_ndc": [
          "10742-8517-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O",
          "4Y5P7MUD51",
          "4X49Y0596W",
          "95OOS7VE0Y"
        ]
      }
    }
  ]
}