{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Vacation Lip Balm Avobenzone, Homosalate, Octisalate, and Octocrylene Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octocrylene Octocrylene Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate Diisostearyl Malate POLYBUTENE (1400 MW) SHEA BUTTER Microcrystalline Wax ETHYLHEXYL COCOATE SYNTHETIC WAX (1200 MW) Disteardimonium Hectorite Astrocaryum Murumuru Seed Butter Vanillin Propylene Carbonate HYALURONATE SODIUM D&C RED NO. 30 Ethylene Brassylate SACCHARIN SODIUM ANHYDROUS .ALPHA.-TOCOPHEROL Caffeine SWEET CHERRY SEED OIL ALKYL (C12-15) BENZOATE GARCINIA KOLA SEED Mica Maltodextrin SORBITAN MONOLAURATE C18-36 Acid Triglyceride Palmitoyl Tripeptide-1 Palmitoyl Tetrapeptide-7"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distr. by Vacation Inc. 936 SW 1st Ave # 888 Miami, FL 33130"
      ],
      "active_ingredient": [
        "Active Ingredients Avobenzone (3%), Homosalate (3%), Octisalate (4%), Octocrylene (10%)"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn & chapped lips"
      ],
      "warnings": [
        "Warnings For external use only Keep out of eyes. Stop use if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "stop_use": [
        "Stop use 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 Reapply at least every 2 hours Use a water resistant sunscreen especially if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Phytosteryl/Isostearyl/Cetyl/ Stearyl/ Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Polyisobutene, Microcrystalline Wax, Octyldodecanol, Polyglyceryl-2 Diisostearate, Flavor, Synthetic Wax, Astrocaryum Murumuru Seed Butter, Disteardimonium Hectorite, Propylene Carbonate, Vanillin, Tocopherol (Vitamin E), Hyaluronic Acid, Ethylene Brassylate, Sodium Saccharin, Garcinia Kola Nut Extract, Prunus Avium (Sweet Cherry) Seed Oil, Caffeine, C12-15 Alkyl Benzoate, Maltodextrin, Sorbitan Laurate, C18-36 Acid Glycol Ester, C18-36 Acid Triglyceride, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Red 30 Lake (CI 73360), Red 7 Lake (CI 15850), Mica (CI 77019), Blue 1 Lake (CI 42090)"
      ],
      "storage_and_handling": [
        "Other Information Protect the product in this container from excessive heat and direct sun."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton PEPSI TINTED LIP GEL SUNSCREEN 0.5 FL OZ / 15 ML PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton"
      ],
      "set_id": "b442530f-cae3-418b-9675-c18879653826",
      "id": "7d6947d5-8d03-4bf2-8ca7-0847efa7c0cc",
      "effective_time": "20260127",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Vacation Lip Balm"
        ],
        "generic_name": [
          "AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE"
        ],
        "manufacturer_name": [
          "Vacation INC."
        ],
        "product_ndc": [
          "80641-520"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "AVOBENZONE",
          "HOMOSALATE",
          "OCTISALATE",
          "OCTOCRYLENE"
        ],
        "spl_id": [
          "7d6947d5-8d03-4bf2-8ca7-0847efa7c0cc"
        ],
        "spl_set_id": [
          "b442530f-cae3-418b-9675-c18879653826"
        ],
        "package_ndc": [
          "80641-520-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "G63QQF2NOX",
          "V06SV4M95S",
          "4X49Y0596W",
          "5A68WGF6WM"
        ]
      }
    }
  ]
}