{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "EIGHT HOUR NOURISHING LIP SPF 20 OCTINOXATE, AVOBENZONE OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE POLYBUTENE (1400 MW) CASTOR OIL NYLON-12 SUNFLOWER OIL BUTYLATED HYDROXYTOLUENE FERRIC OXIDE RED VITAMIN A PALMITATE .ALPHA.-TOCOPHEROL ACETATE ASTROCARYUM MURUMURU SEED BUTTER HYDROGENATED CASTOR OIL LANOLIN MICROCRYSTALLINE WAX SHEA BUTTER GLYCERETH-26 FERRIC OXIDE YELLOW LINOLEIC ACID ALKYL (C12-15) BENZOATE YELLOW WAX HONEY LINOLENIC ACID TOCOPHEROL BUTYLOCTYL SALICYLATE PETROLATUM DIOCTYLDODECYL DODECANEDIOATE"
      ],
      "active_ingredient": [
        "Active Ingredients Active Ingredients Purpose OCTINOXATE 4.0%...................................................Sunscreen AV0BENZONE 3.0%..................................................Sunscreen"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients POLYBUTENE, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PETROLATUM, RICINUS COMMUNIS (CASTOR) SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15 ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HONEY EXTRACT, HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC ACI, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT, RETINYL PALMITATE, TO DCOPHEROL, TOCOPHERYL ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492)."
      ],
      "instructions_for_use": [
        "Uses Uses - Helps prevent sunburn - If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun"
      ],
      "safe_handling_warning": [
        "Warnings Warnings - 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 product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "Directions For Sunscreen Use Directions For Sunscreen Use: - Apply liberally 15 minutes before sun exposure - Reapply: - at least every 2 hours - Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: - Limit time in the sun, especially from 10 a.m. – 2 p.m. - Wear long-sleeve shirts, pants, hats, and sunglasses - Children under 6 months: Ask a doctor."
      ],
      "dosage_and_administration": [
        "Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours"
      ],
      "indications_and_usage": [
        "Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin againg caused by the sun"
      ],
      "keep_out_of_reach_of_children": [
        "Keep Out of Reach of Children . If product is swallowed, get medical help or contact a poison control center right away."
      ],
      "purpose": [
        "Sunscreen"
      ],
      "warnings": [
        "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 using and ask a doctor if rash occurs."
      ],
      "package_label_principal_display_panel": [
        "CARTON ART NOURISHING LIP"
      ],
      "set_id": "b3c16e60-752d-6eba-e053-2995a90a2b20",
      "id": "471d7db4-fbd2-4509-e063-6394a90a02a6",
      "effective_time": "20251229",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "EIGHT HOUR NOURISHING LIP SPF 20"
        ],
        "generic_name": [
          "OCTINOXATE, AVOBENZONE"
        ],
        "manufacturer_name": [
          "REVLON"
        ],
        "product_ndc": [
          "10967-671"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTINOXATE",
          "AVOBENZONE"
        ],
        "spl_id": [
          "471d7db4-fbd2-4509-e063-6394a90a02a6"
        ],
        "spl_set_id": [
          "b3c16e60-752d-6eba-e053-2995a90a2b20"
        ],
        "package_ndc": [
          "10967-671-61"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0012345678905"
        ],
        "unii": [
          "4Y5P7MUD51",
          "G63QQF2NOX"
        ]
      }
    }
  ]
}