{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "SUMMER GELEE SPF-4 HOMOSALATE, OCTISALATE CHINESE CINNAMON OIL FERRIC OXIDE RED ISOPROPYL MYRISTATE MINERAL OIL CERESIN PARAFFIN PETROLATUM .ALPHA.-TOCOPHEROL ACETATE D&C RED NO. 17 HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information: Protect the product in this container from excessive heat and direct sun."
      ],
      "active_ingredient": [
        "Active Ingredients Homosalate 2.00%, Octisalate 2.00% Purpose Sunscreen"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun."
      ],
      "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 or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use."
      ],
      "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 doctor if rash or irritation develops and lasts."
      ],
      "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."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "dosage_and_administration": [
        "Directions: Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am-2pm. Wear long-sleeved shirts, pants, hats, & sunglasses."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Cinnamomum Cassia Oil, Hydrogenated Vegetable Oil, Iron Oxides (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Tocopheryl Acetate (Vitamin E), D&C Red #17."
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "c9ec81ad-0478-4026-bc6c-5582eb012b8d",
      "id": "171b4cde-2e02-0bb4-e063-6394a90a9deb",
      "effective_time": "20240427",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "SUMMER GELEE SPF-4"
        ],
        "generic_name": [
          "HOMOSALATE, OCTISALATE"
        ],
        "manufacturer_name": [
          "SUMMER GELEE LLC"
        ],
        "product_ndc": [
          "84281-476"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HOMOSALATE",
          "OCTISALATE"
        ],
        "spl_id": [
          "171b4cde-2e02-0bb4-e063-6394a90a9deb"
        ],
        "spl_set_id": [
          "c9ec81ad-0478-4026-bc6c-5582eb012b8d"
        ],
        "package_ndc": [
          "84281-476-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V06SV4M95S",
          "4X49Y0596W"
        ]
      }
    }
  ]
}