{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30 OCTOCRYLENE, ZINC OXIDE ALOE VERA LEAF ALUMINUM STARCH OCTENYLSUCCINATE WATER YELLOW WAX CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF CETOSTEARYL ALCOHOL CYCLOMETHICONE 5 DIISOPROPYL ADIPATE DIMETHICONE ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL LAURATE GLYCERYL MONOSTEARATE HYALURONIC ACID C13-14 ISOPARAFFIN LAURETH-7 PEG-100 STEARATE PHENOXYETHANOL SORBITAN MONOSTEARATE STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE OCTOCRYLENE OCTOCRYLENE ZINC OXIDE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS",
        "OTHER INFORMATION: Protect the product in this container from excessive heat and direct sun."
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS: Octocrylene 10.0% Zinc Oxide 7.0% PURPOSE Sunscreen"
      ],
      "purpose": [
        "PURPOSE Sunscreen"
      ],
      "indications_and_usage": [
        "USES: Helps prevent sunburn."
      ],
      "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 occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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 occurs."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "DIRECTIONS: Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *If pregnant or breast-feeding, ask a health care professional before use. *For children under 6 months of age: Ask a doctor."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Starch Octenyl succinate, Aqua (Deionized Water), Beeswax, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Chamomilla Matricaria Extract, Cetearyl Alcohol, Cyclopentasiloxane, Diisopropyl Adipate, Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Hyaluronic Acid, C13-14 Isoparaffin, Laureth-7, Parfum (Fragrance)., PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Sorbitan Stearate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E)."
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Bottle"
      ],
      "set_id": "0f9a507a-1b72-45f8-a8a8-b7a92a85607f",
      "id": "1427e6f9-923d-4285-e063-6294a90a99e5",
      "effective_time": "20240321",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30"
        ],
        "generic_name": [
          "OCTOCRYLENE, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "SOLVADERM LLC"
        ],
        "product_ndc": [
          "84197-467"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTOCRYLENE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "1427e6f9-923d-4285-e063-6294a90a99e5"
        ],
        "spl_set_id": [
          "0f9a507a-1b72-45f8-a8a8-b7a92a85607f"
        ],
        "package_ndc": [
          "84197-467-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5A68WGF6WM",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}