{
  "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": [
        "Lip Clear Lysine Plus Coldstick Octinoxate and Oxybenzone YELLOW WAX CALENDULA OFFICINALIS FLOWER ECHINACEA PURPUREA BENZOIN RESIN GOLDENSEAL LYSINE HYDROCHLORIDE TEA TREE OIL MELALEUCA CAJUPUTI LEAF OIL PROPOLIS WAX VITAMIN A PALMITATE SAFFLOWER CHOLECALCIFEROL CARNAUBA WAX WATER CASTOR OIL JOJOBA OIL .ALPHA.-TOCOPHEROL ACETATE TOCOPHEROL OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: QUANTUM, INC. PO Box 2791, Eugene, OR 97402"
      ],
      "active_ingredient": [
        "Active Ingredients Purpose Octinoxate 7.0% Sunscreen Oxybenzone (Benzophenone-3) 5.0% Sunscreen"
      ],
      "active_ingredient_table": [
        "<table width=\"60%\"><col align=\"left\" valign=\"top\" width=\"80%\"/><col align=\"right\" valign=\"top\" width=\"20%\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Octinoxate 7.0%</td><td>Sunscreen</td></tr><tr><td>Oxybenzone (Benzophenone-3) 5.0%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active Ingredients Purpose Octinoxate 7.0% Sunscreen Oxybenzone (Benzophenone-3) 5.0% Sunscreen"
      ],
      "purpose_table": [
        "<table width=\"60%\"><col align=\"left\" valign=\"top\" width=\"80%\"/><col align=\"right\" valign=\"top\" width=\"20%\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Octinoxate 7.0%</td><td>Sunscreen</td></tr><tr><td>Oxybenzone (Benzophenone-3) 5.0%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "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 help prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. Stop use and consult a doctor if rash occurs. Avoid contact with eyes. If in eyes, rinse with warm water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center."
      ],
      "do_not_use": [
        "Do not use on damaged or broken skin."
      ],
      "stop_use": [
        "Stop use and consult a doctor if rash occurs. Avoid contact with eyes. If in eyes, rinse with warm 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."
      ],
      "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."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Beeswax, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol (Vitamin D), Copernicia Cerifera (Carnauba) Wax, Echinacea Purpurea Extract, Gum Benzoin Tincture, Hydrastis Canadensis (Goldenseal) Extract, Lysine, Melaleuca Alternifolia (Tea Tree) Oil, Melaleuca Cajuputi (Cajeput) Oil, Propolis Extract, Purified Water, Retinyl Palmitate (Vitamin A), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Tocopheryl Acetate (Vitamin E)."
      ],
      "storage_and_handling": [
        "Other Information Protect this product from excessive heat and direct sun."
      ],
      "questions": [
        "Questions? 800-448-1448 www.quantumhealth.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 5 gm Cylinder Blister Pack Inspired by Nature SPF-21 Sunscreen LIP CLEAR ® Lysine+ ® Lip Treatment & Protectant Softens & Protects Soothes & Moisturizes Chapped Lips Goes on Clear Lysine with herbs and nutrients • WITH HERBS • VITAMINS & OTHER TOPICALS QUANTUM ® HEALTH Net Wt. 5 gm / .17 oz. PRINCIPAL DISPLAY PANEL - 5 gm Cylinder Blister Pack"
      ],
      "set_id": "66f84e56-4a5d-4b71-8bd3-79961e7bf4fe",
      "id": "419d7780-3a98-f9d0-e063-6394a90ad7f3",
      "effective_time": "20251020",
      "version": "4",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Lip Clear Lysine Plus Coldstick"
        ],
        "generic_name": [
          "OCTINOXATE AND OXYBENZONE"
        ],
        "manufacturer_name": [
          "Quantum, Inc."
        ],
        "product_ndc": [
          "70084-210"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTINOXATE",
          "OXYBENZONE"
        ],
        "spl_id": [
          "419d7780-3a98-f9d0-e063-6394a90ad7f3"
        ],
        "spl_set_id": [
          "66f84e56-4a5d-4b71-8bd3-79961e7bf4fe"
        ],
        "package_ndc": [
          "70084-210-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0046985017022"
        ],
        "unii": [
          "4Y5P7MUD51",
          "95OOS7VE0Y"
        ]
      }
    }
  ]
}