{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 TITANIUM DIOXIDE and ZINC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE DIMETHICONE BUTYLOCTYL SALICYLATE PHENOXYETHANOL ALKYL (C12-15) BENZOATE ISONONYL ISONONANOATE DIETHYLHEXYL SUCCINATE NEOPENTYL GLYCOL DIHEPTANOATE METHYL TRIMETHICONE BUTYLENE GLYCOL ETHYLHEXYL METHOXYCRYLENE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE SILICON DIOXIDE LAURETH-4 DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE ISOSTEARIC ACID CAPRYLYL GLYCOL TRIETHOXYCAPRYLYLSILANE DIPROPYLENE GLYCOL WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Titanium dioxide 6.3% Zinc oxide 4.0%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn"
      ],
      "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 doctor if rash occurs Keep out of reach of children. If product is 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 occurs"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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 children under 6 months: ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water\\aqua\\eau, dimethicone, butyloctyl salicylate, polydiethylsiloxane, c12-15 alkyl benzoate, isononyl isononanoate, diethylhexyl succinate, neopentyl glycol diheptanoate, methyl trimethicone, butylene glycol, ethylhexyl methoxycrylene, lauryl peg-9 polydimethylsiloxyethyl dimethicone, silica, laureth-4, cetyl peg/ppg-10/1 dimethicone, dipentaerythrityl tri-polyhydroxystearate, dimethicone silylate, hydrolyzed wheat protein/pvp crosspolymer, isostearic acid, caprylyl glycol, dimethicone crosspolymer-3, polyhydroxystearic acid, triethoxycaprylylsilane, dimethicone/peg-10/15 crosspolymer, dipropylene glycol, phenoxyethanol, iron oxides (ci 77491), iron oxides (ci 77492) <iln41905>"
      ],
      "storage_and_handling": [
        "Other information protect the product in this container from excessive heat and direct sun"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton DARPHIN PARIS INTRAL ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF 50 30 ml e/1 FL.OZ.LIQ. PDP"
      ],
      "set_id": "91277514-4db0-4b40-b95a-3530cac711df",
      "id": "26a76872-0814-5d6f-e063-6394a90aa63e",
      "effective_time": "20241111",
      "version": "9",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE AND ZINC OXIDE"
        ],
        "manufacturer_name": [
          "DARPHIN DIST."
        ],
        "product_ndc": [
          "16555-008"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "26a76872-0814-5d6f-e063-6394a90aa63e"
        ],
        "spl_set_id": [
          "91277514-4db0-4b40-b95a-3530cac711df"
        ],
        "package_ndc": [
          "16555-008-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}