{
  "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": [
        "Safe Sea SPF 30 Zinc Oxide MEDIUM-CHAIN TRIGLYCERIDES ALKYL (C12-15) BENZOATE DIBUTYL ADIPATE BUTYLOCTYL SALICYLATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE TRIETHOXYCAPRYLYLSILANE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE MAGNESIUM STEARATE HYDROGENATED CASTOR OIL PANTHENOL .ALPHA.-TOCOPHEROL ACETATE LANTHANUM CHLORIDE MAGNESIUM CHLORIDE CALCIUM CHLORIDE BENZYL ALCOHOL CHLORPHENESIN BENZOIC ACID SORBIC ACID DEHYDROACETIC ACID WATER ZINC OXIDE ZINC CATION"
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 10.9%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn If used as direacted with other sun protection measures (see directions), decreases the risk of skin cancer and early aging skin 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."
      ],
      "dosage_and_administration": [
        "Directions Apply liberally 15 minutes before sun exposure reapply: After 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours Sun Protection MeasuresSpending 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.to 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor."
      ],
      "spl_unclassified_section": [
        "Other Information Give particular attention to coverage of arms and legs. In water infested by Sea Lice, Safe Sea should also be applied under the bathing suit. Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings. In case of sting do not use Safe Sea as a treatment - seek medical attention.*Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file. Protect this product from excessive heat and direct sun."
      ],
      "keep_out_of_reach_of_children": [
        ""
      ],
      "inactive_ingredient": [
        "Inactive ingredients Benzoic Acid, Benzyl Alcohol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Chloride, Caprylic / Capric triglyceride, Chlorphenisine, Dehydroacetic Acid, Dibutyl Adipate, Hydrogenated Castor Oil, Lanthanum Chloride, Magnesium Chloride, Magnesium Stearate, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-4 Diisostearate /Polyhydroxystearate/Sebacate, Sorbic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water"
      ],
      "package_label_principal_display_panel": [
        "Product label image description"
      ],
      "set_id": "91bf07ed-0be4-43c9-b5f3-4e8eb892bca5",
      "id": "445736eb-4083-8204-e063-6394a90a6024",
      "effective_time": "20251124",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Safe Sea SPF 30"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Nidaria Technology Ltd."
        ],
        "product_ndc": [
          "65435-0600"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "445736eb-4083-8204-e063-6394a90a6024"
        ],
        "spl_set_id": [
          "91bf07ed-0be4-43c9-b5f3-4e8eb892bca5"
        ],
        "package_ndc": [
          "65435-0600-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}