{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Derma E Sun Defense Face SPF 30 Zinc Oxide Titanium Dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ALOE VERA LEAF ALUMINUM OXIDE ASCORBIC ACID GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL CAPRYLATE/CAPRATE CARBOXYMETHYLCELLULOSE CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE CETEARYL OLIVATE COCO-GLUCOSIDE DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE ETHYLHEXYLGLYCERIN GLYCERIN ISOSTEARIC ACID LECITHIN, SUNFLOWER MICROCRYSTALLINE CELLULOSE PANTHENOL PHENOXYETHANOL FYTIC ACID POLYGLYCERYL-3 PENTARICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) WATER BETASIZOFIRAN PHYTATE SODIUM SORBITAN OLIVATE STEARIC ACID STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM"
      ],
      "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 Aloe Barbadensis Leaf Juice, Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract Certified Organic Ingredients , 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, Isostearic Acid, Lecithin, Microcrytalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum."
      ],
      "questions": [
        "Questions or comments? Call toll free 1-800-933-9344 or visit dermae.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 56 g Tube Box SUN CARE New & Improved FORMULA DERMA • E Sun Defense Clear Zinc Oil-Free Sunscreen BROAD SPECTRUM SPF 30 Mineral Clear Zinc Oxide Vitamin C & Green Tea 100% Unscented spf 30 FACE • DERMATOLOGIST RECOMMENDED • reef safe 2 OZ / 56 g PRINCIPAL DISPLAY PANEL - 56 g Tube Box"
      ],
      "set_id": "d90b8f81-de7a-4022-800a-90f063e94180",
      "id": "dd9fabd4-2126-49ff-aa1a-1e696ad13c56",
      "effective_time": "20240717",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Derma E Sun Defense Face SPF 30"
        ],
        "generic_name": [
          "ZINC OXIDE TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "derma e"
        ],
        "product_ndc": [
          "54108-0419"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "dd9fabd4-2126-49ff-aa1a-1e696ad13c56"
        ],
        "spl_set_id": [
          "d90b8f81-de7a-4022-800a-90f063e94180"
        ],
        "package_ndc": [
          "54108-0419-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "15FIX9V2JP"
        ]
      }
    }
  ]
}