{
  "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": [
        "Scar Gel SPF 35 Zinc Oxide ZINC OXIDE ZINC OXIDE ALLANTOIN C30-45 ALKYL METHICONE C30-45 OLEFIN MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL TRISILOXANE DIETHYLHEXYL SUCCINATE DIMETHICONE DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER GLYCERYL DIBEHENATE HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER ISOHEXADECANE ISOSTEARIC ACID LECITHIN, SUNFLOWER PANTHENOL PHENOXYETHANOL POLYGLYCERYL-3 PENTARICINOLEATE POLYHYDROXYSTEARIC ACID STEARATE SILICON DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by DERMA E ® Simi Valley, CA 93065, USA"
      ],
      "active_ingredient": [
        "Active Ingredient Zinc Oxide 11.7% }"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "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 Allantoin, C30-45 Alkyl Methicone, C30-45 Olefin, Caprylic/Capric Triglyceride, Caprylyl Methicone, Diethylhexyl Succinate, Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Glyceryl Behenate, HDI/Trimethylol Hexyllactone Crosspolymer, Isohexadecane, Isostearic Acid, Lecithin, Panthenol, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Silica."
      ],
      "questions": [
        "Questions or comments? Call toll free 1-800-933-9344 or visit dermae.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 43 g Tube Box THERAPEUTIC • 100% VEGAN • SOY-FREE • SPF 35 CRUELTY-FREE DERMA•E Scar Cream Sun Protectant SPF 35 BROAD SPECTRUM SPF 35 Reduces Scar Appearance Primes & Nourishes Mineral Sun Protection Panthenol & Allantoin 1.5 OZ / 43 g PRINCIPAL DISPLAY PANEL - 43 g Tube Box"
      ],
      "set_id": "8cd263aa-a54b-4c55-b3e2-6f6763987d4a",
      "id": "04ff8c03-d928-4bfd-88d5-3bf14b9da3c9",
      "effective_time": "20240717",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Scar Gel SPF 35"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "derma e"
        ],
        "product_ndc": [
          "54108-8111"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "04ff8c03-d928-4bfd-88d5-3bf14b9da3c9"
        ],
        "spl_set_id": [
          "8cd263aa-a54b-4c55-b3e2-6f6763987d4a"
        ],
        "package_ndc": [
          "54108-8111-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}