{
  "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": [
        "SPF 50 Mineral Based Facial Sunscreen Titanium Dioxide, Zinc Oxide Titanium Dioxide Titanium Dioxide Zinc Oxide Zinc Oxide BISMUTH OXYCHLORIDE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL POLYOXYL 20 CETOSTEARYL ETHER CYCLOMETHICONE 6 CYCLOMETHICONE 5 DIMETHICONE EDETATE DISODIUM ANHYDROUS ETHYLHEXYL HYDROXYSTEARATE BENZOATE GLYCERIN FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE ISODODECANE ISOHEXADECANE MELISSA OFFICINALIS WHOLE MICA MICROCRYSTALLINE WAX OCTYLDODECYL NEOPENTANOATE PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) SODIUM CHLORIDE TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE TOCOPHEROL TROLAMINE TRIETHOXYCAPRYLYLSILANE WATER"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS: Titanium Dioxide 10% Zinc Oxide 3%"
      ],
      "purpose": [
        "PURPOSE: Sunscreen 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."
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs."
      ],
      "when_using": [
        "When using this product, keep out of eyes. Rinse with water to remove."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the 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. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS: Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water"
      ],
      "other_safety_information": [
        "OTHER INFORMATION: Protect this product from excessive heat and direct sun May stain some fabrics MANUFACTURED FOR: Kathleeen Hutton MD Newport Beach, CA 92660 WWW.HUTTONKLEIN.COM 800-909-0060"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel – 53 g Bottle Label HUTTON KLEIN HK DERMATOLOGISTS SPF 50 Mineral Based Facial Sunscreen Free of Chemical Sunscreens Water-Resistant (40 Minutes) Broad Spectrum Oil and PABA Free Net. Wt. 1.8 oz./ 53 g Figure"
      ],
      "set_id": "5cf0d2e3-d496-424c-ac75-70ff5b87e9ca",
      "id": "d1612c94-e50e-4ba5-a591-a7dfa77fb5f8",
      "effective_time": "20240325",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "SPF 50 Mineral Based Facial Sunscreen"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Hutton, Kathleen MD"
        ],
        "product_ndc": [
          "81679-258"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "d1612c94-e50e-4ba5-a591-a7dfa77fb5f8"
        ],
        "spl_set_id": [
          "5cf0d2e3-d496-424c-ac75-70ff5b87e9ca"
        ],
        "package_ndc": [
          "81679-258-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0381679258504"
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}