{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CoTZ Kids Zinc Oxide ZINC OXIDE ZINC OXIDE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL CYCLOPENTASILOXANE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) DIMETHICONOL (2000 CST) HYDROGEN DIMETHICONE (20 CST) MICROCRYSTALLINE WAX POLYSORBATE 20 EDETATE DISODIUM ANHYDROUS DIMETHICONE POLYGLYCERYL-4 ISOSTEARATE ALPHA-TOCOPHEROL ACETATE WATER STEARYL DIMETHICONE (400 MPA.S AT 50C) TRIETHANOLAMINE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) CYCLOHEXASILOXANE DIMETHICONE CROSSPOLYMER GLYCERIN PEG-30 DIPOLYHYDROXYSTEARATE POLYHYDROXYSTEARIC ACID (2300 MW) TETRAHEXYLDECYL ASCORBATE PEG-10 DIMETHICONE (600 CST) SODIUM CHLORIDE TRIETHOXYCAPRYLYLSILANE C12-15 ALKYL BENZOATE"
      ],
      "active_ingredient": [
        "Active Ingredients: Zinc Oxide 20%"
      ],
      "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 broken or damaged 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 reach of children. If swallowed, get medical help or contact a poison control center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Warnings: Keep out of reach of children"
      ],
      "dosage_and_administration": [
        "Directions: Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply 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 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses."
      ],
      "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, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water"
      ],
      "other_safety_information": [
        "Other Information: For 6 Months and older"
      ],
      "package_label_principal_display_panel": [
        "Package Label"
      ],
      "set_id": "3ca914e2-cd53-42bf-e063-6294a90a7082",
      "id": "3ca914e2-cd54-42bf-e063-6294a90a7082",
      "effective_time": "20250818",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "CoTZ Kids"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Fallien Cosmeceuticals, LTD."
        ],
        "product_ndc": [
          "58892-619"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "3ca914e2-cd54-42bf-e063-6294a90a7082"
        ],
        "spl_set_id": [
          "3ca914e2-cd53-42bf-e063-6294a90a7082"
        ],
        "package_ndc": [
          "58892-619-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}