{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sun Shades Lip Balm Pina Colada Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% ALKYL (C12-15) BENZOATE ALPHA-TOCOPHEROL ACETATE AMMONIUM GLYCYRRHIZATE CERESIN CETYL ESTERS WAX COCOA BUTTER ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) JOJOBA OIL PETROLATUM YELLOW WAX CANDELILLA WAX AVOBENZONE AVOBENZONE OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE"
      ],
      "active_ingredient": [
        "Active ingredients Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "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"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "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 dcotor 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 if swimming or sweating ■ children under 6 months of age: ask a doctor ■ 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 10 a.m.-2 p.m.■ wear long-sleeve shirts, pants, hats, and sunglasses"
      ],
      "clinical_studies": [
        "Other information ■ dermatologist and allergy tested"
      ],
      "storage_and_handling": [
        "■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients petrolatum USP, beeswax, simmondsia chinensis (jojoba) seed oil, euphorbia cerifera (candelilla) wax, cetyl esters, theobroma cacao (cocoa) seed butter, flavor, C12-15 alkyl benzoate, stearyl dimethicone, tocopheryl acetate (vitamin E USP), ethylene/VA copolymer, ammonium glycyrrhizate"
      ],
      "package_label_principal_display_panel": [
        "Sun Shades Lip Balm Pina Colada label.jpg"
      ],
      "set_id": "16d0d2d2-b9c4-4491-8d8a-815843d342e8",
      "id": "4747c8ff-53eb-ef14-e063-6294a90ae4e0",
      "effective_time": "20251231",
      "version": "7",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Sun Shades Lip Balm Pina Colada"
        ],
        "generic_name": [
          "AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%"
        ],
        "manufacturer_name": [
          "Melaleuca Inc."
        ],
        "product_ndc": [
          "54473-226"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "AVOBENZONE",
          "OCTINOXATE",
          "OXYBENZONE"
        ],
        "spl_id": [
          "4747c8ff-53eb-ef14-e063-6294a90ae4e0"
        ],
        "spl_set_id": [
          "16d0d2d2-b9c4-4491-8d8a-815843d342e8"
        ],
        "package_ndc": [
          "54473-226-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "G63QQF2NOX",
          "4Y5P7MUD51",
          "95OOS7VE0Y"
        ]
      }
    }
  ]
}