{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hydra Finish SPF 15 HOMOSALATE, OCTINOXATE HOMOSALATE HOMOSALATE OCTINOXATE OCTINOXATE WATER TITANIUM DIOXIDE CYCLOMETHICONE 5 ETHYLHEXYL STEARATE GLYCERIN C14-22 ALCOHOLS CYCLOMETHICONE 6 DIETHYLHEXYL 2,6-NAPHTHALATE HYDROGENATED COCO-GLYCERIDES PROPANEDIOL CELLULOSE, MICROCRYSTALLINE GLYCERYL STEARATE CITRATE PENTYLENE GLYCOL FERRIC OXIDE YELLOW PROPYLENE GLYCOL MICA ISOPROPYL MYRISTATE BEMOTRIZINOL C12-20 ALKYL GLUCOSIDE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) HYDROGENATED SOYBEAN LECITHIN .ALPHA.-TOCOPHEROL ACETATE ETHYLHEXYLGLYCERIN TRIETHYL CITRATE HEXYLDECANOL SILICON DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM POLYOXYL 20 CETOSTEARYL ETHER TROLAMINE BETAINE PECTIN POLYSORBATE 60 SORBITAN ISOSTEARATE SUCROSE BUTYLENE GLYCOL CAPRYLOYL GLYCINE HYALURONATE SODIUM D&C RED NO. 33 MALVA SYLVESTRIS FLOWERING TOP APPLE SEED RAPESEED STEROL TOCOPHEROL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information Protect this product from excessive heat and direct sun"
      ],
      "active_ingredient": [
        "Active ingredients Homosalate 4.0% Octinoxate 6.0% purpose Sunscreen"
      ],
      "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 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 Apply liberally 15 minutes before sun exposure Reapply at least every 2 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 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 (Aqua), Titanium Dioxide (CI 77891), Cyclopentasiloxane, Ethylhexyl Stearate, Glycerin, C14- 22 Alcohols, Cyclohexasiloxane, Diethylhexyl 2,6-Naphthalate, Hydrogenated Coco-Glycerides, Propanediol, Microcrystalline Cellulose, Glyceryl Stearate Citrate, Pentylene Glycol, Iron Oxides (CI 77492), Propylene Glycol, Polyglyceryl-3 Stearate, Mica, Acrylates/Ammonium Methacrylate Copolymer, Isopropyl Myristate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-20 Alkyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance (Parfum), Hydrogenated Lecithin, Tocopheryl Acetate, Ethylhexylglycerin, Triethyl Citrate, Hexyldecanol, Silica, Iron Oxides (CI 77499), Iron Oxides (CI 77491), Cellulose Gum, Ceteareth-20, Triethanolamine, Betaine, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Pectin, Polysorbate 60, Sorbitan Isostearate, Sucrose, Butylene Glycol, Capryloyl Glycine, Sodium Hyaluronate, Red 33 (CI 17200), Malva Sylvestris (Mallow) Extract, Pyrus Malus (Apple) Seed Extract, Brassica Campestris (Rapeseed) Sterols, Tocopherol. 01"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: 54181-006-30 Outer Inner"
      ],
      "set_id": "4047e8ec-834a-41e6-a144-5649a7718de4",
      "id": "5b1ce64a-c6e2-52bd-e063-6394a90a3abd",
      "effective_time": "20260910",
      "version": "11",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Hydra Finish SPF 15"
        ],
        "generic_name": [
          "HOMOSALATE, OCTINOXATE"
        ],
        "manufacturer_name": [
          "Guinot"
        ],
        "product_ndc": [
          "54181-006"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HOMOSALATE",
          "OCTINOXATE"
        ],
        "spl_id": [
          "5b1ce64a-c6e2-52bd-e063-6394a90a3abd"
        ],
        "spl_set_id": [
          "4047e8ec-834a-41e6-a144-5649a7718de4"
        ],
        "package_ndc": [
          "54181-006-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "3500465068753"
        ],
        "unii": [
          "V06SV4M95S",
          "4Y5P7MUD51"
        ]
      }
    }
  ]
}