{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Physical Sunscreen SPF50 80 min WR 159-100 titanium dioxide, titanium dioxide sunscreen TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION WATER C15-19 ALKANE OCTYLDODECYL NEOPENTANOATE BUTYLOCTYL SALICYLATE DIMETHICONE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE GLYCERIN POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM CHLORIDE TRIETHOXYCAPRYLYLSILANE SACCHARIDE ISOMERATE HYDROXYACETOPHENONE NIACINAMIDE SORBITAN OLIVATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL EDETATE DISODIUM PENTYLENE GLYCOL GELLAN GUM (LOW ACYL) POLYGONUM AVICULARE WHOLE ANHYDROUS CITRIC ACID SODIUM CITRATE POTASSIUM SORBATE SODIUM BENZOATE MEDIUM-CHAIN TRIGLYCERIDES HYDROGENATED POLYBUTENE (1300 MW) SILICON DIOXIDE GLYCERYL MONOBEHENATE .ALPHA.-TOCOPHEROL ACETATE"
      ],
      "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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away."
      ],
      "active_ingredient": [
        "Active Ingredients Titanium Dioxide 4.23% Sunscreen Zinc Oxide 18.28% Sunscreen"
      ],
      "purpose": [
        "Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
      ],
      "dosage_and_administration": [
        "Directions Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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 this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children Keep out of reach of children"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, C15-19 Alkane, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Dimethicone, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Hydrogenated Polyisobutene, Polyhydroxystearic Acid, Sodium Chloride, Triethoxycaprylylsilane, Silica, Saccharide Isomerate, Hydroxyacetophenone, Niacinamide, Sorbitan Olivate, Glyceryl Behenate, 1,2-Hexanediol, Caprylyl Glycol, Tocopheryl Acetate, Disodium EDTA, Scenedesmus Rubescens Extract, Gellan Gum, Polygonum Aviculare Extract, citric acid, sodium citrate, potassium sorbate, sodium benzoate"
      ],
      "other_safety_information": [
        "Other information Protect this product from excessive heat and direct sun."
      ],
      "questions": [
        "Questions Call toll free 1-866-416-2366"
      ],
      "package_label_principal_display_panel": [
        "Labeling PL041 Drug Facts"
      ],
      "set_id": "0cca7b65-e24a-429c-b157-5f4e343424ab",
      "id": "6943f1b5-dc1d-49af-a51e-4c4bb778c45b",
      "effective_time": "20231109",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Physical Sunscreen SPF50 80 min WR 159-100"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN"
        ],
        "manufacturer_name": [
          "Swiss-American CDMO, LLC"
        ],
        "product_ndc": [
          "60232-0044"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "6943f1b5-dc1d-49af-a51e-4c4bb778c45b"
        ],
        "spl_set_id": [
          "0cca7b65-e24a-429c-b157-5f4e343424ab"
        ],
        "package_ndc": [
          "60232-0044-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}