{
  "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": "2026-06-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Pro-Sil SPF Silicone stick with SPF OCTINOXATE OCTINOXATE SILICON AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE"
      ],
      "description": [
        "DESCRIPTION: PROSIL SPF15 SILICONE STICK FOR SCARS GLIDE-ON THERAPY FOR YOUR SCARS"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS: Avobenzone - 3% Sunscreen Octocrylene - 5% Sunscreen agent Octinoxate - 4% Sunscreen agent"
      ],
      "dosage_and_administration": [
        "DOSAGE & ADMINISTRATION: Apply 15 minutes before sun exposure. Clean and dry scar site before each application. Apply Pro-Sil® liberally over the entire scar. May be covered with a bandage. Repeat several times daily for 8–12 weeks or until scar stops responding. To remove, wipe off with a clean cloth or tissue."
      ],
      "purpose": [
        "PURPOSE: SILICONE STICK FOR SCARS BROAD SPECTRUM UVA/UVB SUNSCREEN HELPS PREVENT SUNBURN"
      ],
      "indications_and_usage": [
        "INDICATIONS & USAGE: SILICONE STICK FOR SCARS BROAD SPECTRUM UVA/UVB SUNSCREEN HELPS PREVENT SUNBURN"
      ],
      "instructions_for_use": [
        "DIRECTIONS: Apply 15 minutes before sun exposure. Clean and dry scar site before each application. Apply Pro-Sil® liberally over the entire scar. May be covered with a bandage. Repeat several times daily for 8–12 weeks or until scar stops responding. To remove, wipe off with a clean cloth or tissue. Store between 55°F–95°F (13°C–35°C)."
      ],
      "warnings": [
        "WARNINGS: FOR EXTERNAL USE ONLY"
      ],
      "warnings_and_cautions": [
        "WARNINGS AND PRECAUTIONS: EXTERNAL USE ONLY CAUTIONS: Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin. For children under 5 year of age, use under adult supervision. Children under 6 months of age: Ask a doctor."
      ],
      "ask_doctor_or_pharmacist": [
        "CAUTIONS: Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin. For children under 5 year of age, use under adult supervision. Children under 6 months of age: Ask a doctor."
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN: KEEP OUT OF REACH OF CHILDREN:"
      ],
      "ask_doctor": [
        "ASK A DOCTOR: Ask a doctor about using PROSIL SPF with children under 6 months old."
      ],
      "storage_and_handling": [
        "STORAGE: Store between 55°F–95°F (13°C–35°C)."
      ],
      "questions": [
        "CONTACT INFORMATION: MADE IN THE USA U.S. Patent No. 8,557,287 BIODERMIS LLC 1820 Whitney Mesa Drive, Suite 100 Henderson, Nevada 89014 USA 800.322.3729 (USA) 702.260.4466 (INTL) www.biodermis.com"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Silicone"
      ],
      "package_label_principal_display_panel": [
        "Primary Package Label 4.25g Tube: 17g Tube: 1g Sample Tube: 4.25g 17g 1g Sample"
      ],
      "set_id": "3be06f82-935d-b1c2-e063-6294a90a953c",
      "id": "3c19544e-15e2-2a0f-e063-6394a90aee34",
      "effective_time": "20250811",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Pro-Sil SPF"
        ],
        "generic_name": [
          "SILICONE STICK WITH SPF"
        ],
        "manufacturer_name": [
          "Biodermis, LLC"
        ],
        "product_ndc": [
          "84440-608"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "AVOBENZONE",
          "OCTINOXATE",
          "OCTOCRYLENE"
        ],
        "spl_id": [
          "3c19544e-15e2-2a0f-e063-6394a90aee34"
        ],
        "spl_set_id": [
          "3be06f82-935d-b1c2-e063-6294a90a953c"
        ],
        "package_ndc": [
          "84440-608-01",
          "84440-608-42",
          "84440-608-17"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "G63QQF2NOX",
          "4Y5P7MUD51",
          "5A68WGF6WM"
        ]
      }
    }
  ]
}