{
  "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 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"
      ],
      "active_ingredient": [
        "Active ingredients Octinoxate 7.5% Octisalate 5%"
      ],
      "purpose": [
        "Purpose Octinoxate - Sunscreen Octisalate - Sunscreen"
      ],
      "indications_and_usage": [
        "Uses helps prevent sunburn"
      ],
      "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 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"
      ],
      "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 lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecene copolymer, mineral oil, bis-diglyceryl 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"
      ],
      "questions": [
        "Questions? Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Softlips Pearl",
        "Principal Display Panel Drug Facts"
      ],
      "set_id": "43e175b4-7a48-431e-bf27-9ce7dee53f5e",
      "id": "2979d20c-f978-246c-e063-6294a90a2df5",
      "effective_time": "20241217",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Softlips Pearl"
        ],
        "generic_name": [
          "OCTINOXATE, OCTISALATE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8573"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTINOXATE",
          "OCTISALATE"
        ],
        "spl_id": [
          "2979d20c-f978-246c-e063-6294a90a2df5"
        ],
        "spl_set_id": [
          "43e175b4-7a48-431e-bf27-9ce7dee53f5e"
        ],
        "package_ndc": [
          "10742-8573-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4Y5P7MUD51",
          "4X49Y0596W"
        ]
      }
    }
  ]
}