{
  "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": [
        "Lip Balm SPF15 Pina Colada flavored Lip Balm SPF15 Pina Colada flavored BHT OCTISALATE OCTISALATE SYNTHETIC WAX (1800 MW) PHENOXYETHANOL POLYISOBUTYLENE (1000 MW) OLEA EUROPAEA (OLIVE) FRUIT OIL BEESWAX FRAGRANCE 13576 HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE MINERAL OIL CERESIN COCOS NUCIFERA (COCONUT) OIL BUTYROSPERMUM PARKII (SHEA) BUTTER ETHYLHEXYL PALMITATE Pina Colada"
      ],
      "description": [
        "Drug Facts Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Octocrylene 3% Homosalate 5% Avobenzone 2% Octisalate 3%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn"
      ],
      "warnings": [
        "Warnings For external use only Do not Use on Damaged or Broken Skin"
      ],
      "stop_use": [
        "Stop Use and Ask a Doctor if rash occurs"
      ],
      "when_using": [
        "When using this product keep out of eyes. Rinse with 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 right away"
      ],
      "dosage_and_administration": [
        "Directions ▪ Apply liberally 15 minutes before sun exposure ▪ Reapply at least every 2 hours ▪ Use a water resistant sunscreen if swimming or sweating ▪Children under 6 months of age: Ask a doctor"
      ],
      "spl_unclassified_section": [
        "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 value of 15 or higher and other sun protection measures including: ▪Limit time in the sun, especially from 10am to 2 pm ▪ Wear long sleeved shirts, pants, hats, and sunglasses"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Beeswax, mineral oil, ethylhexyl palmitate, ozokerite, cocos nucifera (coconut) oil, olea europaea (olive) fruit oil, polyisobutene, butyrosperm: um parkii (shea) butter, fragrance, synthetic wax, phenoxyethanol, BHT."
      ],
      "questions": [
        "Questions or Comments? Call weekdays from 9AM to 5PM EST at 631-231-2300"
      ],
      "package_label_principal_display_panel": [
        "Package Label PDP Lip Balm SPF15 Pina Colada flavored (NDC 72449-306-01) LB100FCT Pina Colada Label 2.17.25"
      ],
      "set_id": "31440153-e7ca-1327-e063-6294a90a562c",
      "id": "31440153-e7cb-1327-e063-6294a90a562c",
      "effective_time": "20250326",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Lip Balm SPF15 Pina Colada flavored"
        ],
        "generic_name": [
          "LIP BALM SPF15 PINA COLADA FLAVORED"
        ],
        "manufacturer_name": [
          "LS Promotions Inc"
        ],
        "product_ndc": [
          "72449-306"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTISALATE",
          "HOMOSALATE",
          "OCTOCRYLENE",
          "AVOBENZONE"
        ],
        "spl_id": [
          "31440153-e7cb-1327-e063-6294a90a562c"
        ],
        "spl_set_id": [
          "31440153-e7ca-1327-e063-6294a90a562c"
        ],
        "package_ndc": [
          "72449-306-01"
        ],
        "original_packager_product_ndc": [
          "82953-028"
        ],
        "unii": [
          "4X49Y0596W",
          "V06SV4M95S",
          "5A68WGF6WM",
          "G63QQF2NOX"
        ]
      }
    }
  ]
}