{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Softlips Pearl Plus Vanilla dimethicone, octinoxate, octisalate, oxybenzone Softlips Pearl octinoxate, octisalate LANOLIN OIL HYDROGENATED POLYBUTENE (1300 MW) CERESIN MEADOWFOAM SEED OIL VINYLPYRROLIDONE/HEXADECENE COPOLYMER MINERAL OIL BIS-DIGLYCERYL POLYACYLADIPATE-2 OLEYL ALCOHOL CARNAUBA WAX CASTOR OIL CETYL LACTATE PARAFFIN AMMONIUM GLYCYRRHIZATE BUTYLATED HYDROXYTOLUENE MAGNESIUM STEARATE MENTHOL, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL BISMUTH OXYCHLORIDE CARMINIC ACID MICA TITANIUM DIOXIDE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE Softlips Vanilla 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"
      ],
      "spl_unclassified_section": [
        "Softlips Pearl Drug Facts",
        "Softlips Vanilla Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Octinoxate 7.5% Octisalate 5%",
        "Active Ingredient Dimethicone 2% Octinoxate 7.5% Octisalate 3% Oxybenzone 3%"
      ],
      "purpose": [
        "Purpose Octinoxate – Sunscreen Octisalate - Sunscreen",
        "Purpose Dimethicone – Skin protectant Octinoxate – Sunscreen Octisalate – Sunscreen Oxybenzone - Sunscreen"
      ],
      "indications_and_usage": [
        "Uses helps prevent sunburn",
        "Uses helps prevent sunburn temporarily protects chapped or cracked lips"
      ],
      "warnings": [
        "Warnings Skin Cancer/Skin Agent 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.",
        "Warnings Skin Cancer/Skin Agent 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",
        "Do not use on damaged or broken skin"
      ],
      "when_using": [
        "When Using this product keep out of eyes. Rinse with water to remove.",
        "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",
        "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.",
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Dosage and Administration 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",
        "Dosage and Administration 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",
        "Other information protect this product from excessive heat and direct sun"
      ],
      "inactive_ingredient": [
        "Inactive ingredients lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide",
        "Inactive ingredients ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, flavor, menthol, tocopheryl acetate [vitamin E]"
      ],
      "questions": [
        "Questions or comments? 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST) Softlips.com",
        "Questions or comments? 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST) Softlips.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Front Blistercard",
        "Principal Display Panel Back Blistercard"
      ],
      "set_id": "107bcaa9-4347-4979-be44-35183a9ee67e",
      "id": "2978d002-ed43-0525-e063-6394a90a982f",
      "effective_time": "20241217",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Softlips Pearl Plus Vanilla"
        ],
        "generic_name": [
          "DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-7011"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "spl_id": [
          "2978d002-ed43-0525-e063-6394a90a982f"
        ],
        "spl_set_id": [
          "107bcaa9-4347-4979-be44-35183a9ee67e"
        ],
        "package_ndc": [
          "10742-7011-1"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}