{
  "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": [
        "Dermaka Sunscreen SPF 42, Tinted TITANIUM DIOXIDE, ZINC OXIDE ALOE VERA LEAF JUICE WATER BROMELAIN BUTYLOCTYL SALICYLATE GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL/CAPRYL OLIGOGLUCOSIDE CETOSTEARYL ALCOHOL COCONUT OIL DODECANE GLYCERIN GLYCERYL MONOCAPRYLATE GLYCERYL STEARATE SE HELIANTHUS ANNUUS FLOWERING TOP HYDROXYETHYL CELLULOSE, UNSPECIFIED FERRIC OXIDE RED STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE CORN TITANIUM DIOXIDE CI 77891 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 Titanium Dioxide 6.00 % Zinc Oxide 7.70 % Purpose Sunscreen"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "USES: Helps prevent sunburn. higher SPF gives more sunburn protection 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 not intended for ingestion. 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 or irritation develops and lasts. Keep out of reach of children. If 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 or irritation develops and lasts."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If 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. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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-sleeved shirts, pants, hats, and sunglasses."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Bromelain, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Caprylyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hawthorn Extract, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Iron Oxides (Black, Red, White, Yellow), Polyhydroxystearic Acid, Sambucus Nigra (Elderberry) Extract, Sodium Polyacrylate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol."
      ],
      "questions": [
        "Questions? (772) 266-3376"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label0"
      ],
      "set_id": "9a967cd1-9eec-4255-b14b-ac2e33e4dbf0",
      "id": "37b123bf-b595-e935-e063-6394a90a6dd0",
      "effective_time": "20250616",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Dermaka Sunscreen SPF 42, Tinted"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "DERMAKA SKIN PRODUCTS"
        ],
        "product_ndc": [
          "82240-619"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "37b123bf-b595-e935-e063-6394a90a6dd0"
        ],
        "spl_set_id": [
          "9a967cd1-9eec-4255-b14b-ac2e33e4dbf0"
        ],
        "package_ndc": [
          "82240-619-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}