{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Derma E Sun Defense SPF 30 Zinc Oxide and Titanium Dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ALUMINUM OXIDE ASCORBIC ACID GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL CAPRYLATE/CAPRATE CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE CETEARYL OLIVATE COCO-CAPRYLATE COCO-GLUCOSIDE DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE ETHYLHEXYLGLYCERIN GLYCERIN SUNFLOWER OIL ISOSTEARIC ACID LECITHIN, SUNFLOWER MICROCRYSTALLINE CELLULOSE PANTHENOL PHENOXYETHANOL FYTIC ACID POLYGLYCERYL-3 PENTARICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) WATER BETASIZOFIRAN SHEA BUTTER PHYTATE SODIUM SORBITAN OLIVATE STEARIC ACID STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM CARBOXYMETHYLCELLULOSE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by DERMA E ® Simi Valley, CA 93065, USA"
      ],
      "active_ingredient": [
        "Active Ingredient Purpose Zinc Oxide 19.5% } Sunscreen Titanium Dioxide 2.64% } Sunscreen"
      ],
      "active_ingredient_table": [
        "<table width=\"60%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredient</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Zinc Oxide 19.5% }</td><td>Sunscreen</td></tr><tr><td>Titanium Dioxide 2.64% }</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active Ingredient Purpose Zinc Oxide 19.5% } Sunscreen Titanium Dioxide 2.64% } Sunscreen"
      ],
      "purpose_table": [
        "<table width=\"60%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredient</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Zinc Oxide 19.5% }</td><td>Sunscreen</td></tr><tr><td>Titanium Dioxide 2.64% }</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "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 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 liberally 15 minutes before sun exposure 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 broad spectrum SPF 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 reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating"
      ],
      "storage_and_handling": [
        "Other information protect this product from excessive heat and direct sun"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Cellulose Gum, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Coco-Caprylate, Coco-Glucoside, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isostearic Acid, Lecithin, Microcrystalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Butyrospermum Parkii (Shea) Butter, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum. *Certified Organic Ingredients"
      ],
      "questions": [
        "Questions or comments? Call toll free 1-800-933-9344 or visit dermae.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 113 g Tube Box SUN CARE New & Improved FORMULA DERMA • E Sun Defense Clear Zinc Sunscreen BROAD SPECTRUM SPF 30 Mineral Clear Zinc Oxide Vitamin E & Shea Butter 100% Unscented spf 30 BODY DERMATOLOGIST RECOMMENDED reef safe 4 OZ / 113 g PRINCIPAL DISPLAY PANEL - 113 g Tube Box"
      ],
      "set_id": "395b73a4-dae7-49da-9dab-ab622117c8c0",
      "id": "61d20f28-5db0-4155-84f2-10302b84002e",
      "effective_time": "20240712",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Derma E Sun Defense SPF 30"
        ],
        "generic_name": [
          "ZINC OXIDE AND TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "derma e"
        ],
        "product_ndc": [
          "54108-0418"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "61d20f28-5db0-4155-84f2-10302b84002e"
        ],
        "spl_set_id": [
          "395b73a4-dae7-49da-9dab-ab622117c8c0"
        ],
        "package_ndc": [
          "54108-0418-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "15FIX9V2JP"
        ]
      }
    }
  ]
}