{
  "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": [
        "cle de peau BEAUTE CORRECTING VEIL n M ENSULIZOLE, OCTINOXATE, and ZINC OXIDE TOCOPHEROL TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) TREHALOSE GLYCINE PEG/PPG-14/7 DIMETHYL ETHER ROSA ROXBURGHII FRUIT ANGELICA ACUTILOBA ROOT DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) PERILLA FRUTESCENS LEAF TROLAMINE ISOSTEARIC ACID HYDROGEN DIMETHICONE (13 CST) EDETATE DISODIUM ETHYLHEXYLGLYCERIN ALUMINUM HYDROXIDE BUTYLATED HYDROXYTOLUENE TRIETHOXYCAPRYLYLSILANE SODIUM CITRATE, UNSPECIFIED FORM SODIUM METABISULFITE BARIUM SULFATE THEANINE CITRIC ACID MONOHYDRATE CHLORPHENESIN TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MICA ENSULIZOLE ENSULIZOLE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE WATER DIMETHICONE BUTYLENE GLYCOL GLYCERIN ISOHEXADECANE ISODECYL NEOPENTANOATE ALCOHOL POLYMETHYLSILSESQUIOXANE (11 MICRONS) CETYL ETHYLHEXANOATE PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE NYLON-12 TRIISOSTEARIN DISTEARDIMONIUM HECTORITE ERYTHRITOL XYLITOL SILICON DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information protect this product in this container from excessive heat and direct sun."
      ],
      "active_ingredient": [
        "Active ingredients Purpose ENSULIZOLE 1.0% Sunscreen OCTINOXATE 3.9% Sunscreen ZINC OXIDE 9.7% Sunscreen"
      ],
      "active_ingredient_table": [
        "<table width=\"60%\"><col width=\"60%\" align=\"left\" valign=\"middle\"/><col width=\"40%\" align=\"right\" valign=\"middle\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td>ENSULIZOLE 1.0%</td><td>Sunscreen</td></tr><tr><td>OCTINOXATE 3.9%</td><td>Sunscreen</td></tr><tr><td>ZINC OXIDE 9.7%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purpose ENSULIZOLE 1.0% Sunscreen OCTINOXATE 3.9% Sunscreen ZINC OXIDE 9.7% Sunscreen"
      ],
      "purpose_table": [
        "<table width=\"60%\"><col width=\"60%\" align=\"left\" valign=\"middle\"/><col width=\"40%\" align=\"right\" valign=\"middle\"/><thead><tr><th><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients</content></content></th><th><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></th></tr></thead><tbody><tr><td>ENSULIZOLE 1.0%</td><td>Sunscreen</td></tr><tr><td>OCTINOXATE 3.9%</td><td>Sunscreen</td></tr><tr><td>ZINC OXIDE 9.7%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "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 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 use a water resistant sunscreen if swimming or sweating reapply 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 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients WATER∙DIMETHICONE∙BUTYLENE GLYCOL∙GLYCERIN∙ISOHEXADECANE∙ISODECYL NEOPENTANOATE∙SD ALCOHOL 40-B∙POLYMETHYLSILSESQUIOXANE∙CETYL ETHYLHEXANOATE∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙NYLON-12∙TRIISOSTEARIN∙DISTEARDIMONIUM HECTORITE∙ERYTHRITOL∙XYLITOL∙SILICA∙TRIMETHYLSILOXYSILICATE∙TREHALOSE∙GLYCINE∙PEG/PPG-14/7 DIMETHYL ETHER∙ROSA ROXBURGHII FRUIT EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙PERILLA OCYMOIDES LEAF EXTRACT∙TRIETHANOLAMINE∙ISOSTEARIC ACID∙HYDROGEN DIMETHICONE∙DISODIUM EDTA∙ETHYLHEXYLGLYCERIN∙ALUMINUM HYDROXIDE∙BHT∙POLYSILICONE-2∙TOCOPHEROL∙TRIETHOXYCAPRYLYLSILANE∙SODIUM CITRATE∙SODIUM METABISULFITE∙BARIUM SULFATE∙THEANINE∙CITRIC ACID∙METHYL METHACRYLATE CROSSPOLYMER∙CHLORPHENESIN∙FRAGRANCE∙TITANIUM DIOXIDE∙IRON OXIDES∙MICA∙"
      ],
      "questions": [
        "Questions or comments? Call toll free 1-800-906-7503"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 37 mL Tube Carton clé de peau BEAUTÉ CORRECTING CREAM VEIL n BROAD SPECTRUM SPF 21 SUNSCREEN 37mL NET WT. 1.4 OZ. PRINCIPAL DISPLAY PANEL - 37 mL Tube Carton"
      ],
      "set_id": "15a258a0-61c3-4419-bcdb-a8197d5ae46f",
      "id": "47a7bfe7-469c-6ab5-e063-6394a90a13e8",
      "effective_time": "20260105",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "cle de peau BEAUTE CORRECTING VEIL n M"
        ],
        "generic_name": [
          "ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE"
        ],
        "manufacturer_name": [
          "SHISEIDO AMERICAS CORPORATION"
        ],
        "product_ndc": [
          "58411-892"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ENSULIZOLE",
          "OCTINOXATE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "47a7bfe7-469c-6ab5-e063-6394a90a13e8"
        ],
        "spl_set_id": [
          "15a258a0-61c3-4419-bcdb-a8197d5ae46f"
        ],
        "package_ndc": [
          "58411-892-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9YQ9DI1W42",
          "4Y5P7MUD51",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}