{
  "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": [
    {
      "effective_time": "20121218",
      "inactive_ingredient": [
        "Inactive Ingredients: C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water Manufactured exclusively for Fallien, Ltd. West Norriton PA 19403 Made in USA"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "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."
      ],
      "warnings": [
        "Warnings: For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product, keep out of eyes. Rinse with water to remove."
      ],
      "spl_product_data_elements": [
        "Solar Protection Formula TiZO SPF 35 Sunscreen Zinc Oxide Zinc Oxide Zinc Oxide Alkyl (C12-15) Benzoate Caprylhydroxamic Acid Caprylyl Glycol Cetyl PEG/PPG-10/1 Dimethicone (HLB 5) Cyclomethicone 6 Cyclomethicone 5 Dimethicone 100 Dimethicone/Diene Dimethicone Crosspolymer Edetate Disodium Methicone (20 cst) Microcrystalline Wax PEG-10 Dimethicone (600 cst) PEG-30 Dipolyhydroxystearate Polyglyceryl-4 Isostearate Polyhydroxystearic Acid (2300 MW) Polysorbate 20 Sodium Chloride Stearyl Dimethicone (400 MPA.S AT 50C) Tetrahexyldecyl Ascorbate .Alpha.-Tocopherol Acetate Trolamine Triethoxycaprylylsilane Water"
      ],
      "openfda": {},
      "version": "1",
      "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 10:00 a.m.-2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS",
        "Other Information: Protect this product from excessive heat and direct sun May stain some fabrics"
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs."
      ],
      "do_not_use": [
        "Do not use on damaged or broken skin."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel – SPF 35 100g Carton Label NDC 58892-318-01 SOLAR PROTECTION FORMULA ® TiZO ® For Ultra Sensitive Skin 20% Zinc Oxide Pure Mineral Protection SPF 35 Broad Spectrum Water Resistant (40 minutes) Net Wt. 3.5 Oz./ 100g Principal Display Panel – SPF 35 100g Carton Label"
      ],
      "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."
      ],
      "set_id": "a9de01a9-9b33-4f0e-ac99-0484f3d9fb9e",
      "id": "3279ee92-0ab5-498e-8483-3e7ee6a00824",
      "active_ingredient": [
        "Active Ingredients: Zinc Oxide 20%"
      ]
    }
  ]
}