{
  "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": [
        "Utu Hydrating Sun Balm Broad Spectrum SPF 50 Zinc Oxide ZINC OXIDE ZINC OXIDE PALM OIL BUTYROSPERMUM PARKII (SHEA) BUTTER COCOS NUCIFERA (COCONUT) OIL .ALPHA.-TOCOPHEROL LINOLEATE, D- HAEMATOCOCCUS PLUVIALIS CERAMIDE NP GLYCERYL 1-UNDECYLENATE HIPPOPHAE RHAMNOIDES FRUIT OIL PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL GLYCERYL CAPRYLATE TAPIOCA STARCH CETEARYL ALCOHOL BISABOLOL EUPHORBIA CERIFERA (CANDELILLA) WAX CURCUMA LONGA (TURMERIC) ROOT WATER COPERNICIA CERIFERA (CARNAUBA) WAX POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) TREMELLA FUCIFORMIS FRUITING BODY POLYGLYCERYL-4 OLIVATE/POLYRICINOLEATE ELAEIS GUINEENSIS (PALM) BUTTER"
      ],
      "indications_and_usage": [
        "Uses 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."
      ],
      "dosage_and_administration": [
        "Directions • Apply liberally and evenly 15 minutes before sun exposure • Reapply after 80 minutes of swimming or sweating • Immediately after towel drying • 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10am-2pm. • Wear long-sleeve shirts, pants, hats and sunglasses."
      ],
      "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": [
        "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Prunus Amygdalus Dulcis (Sweet Almond Oil), Vegetable Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Simmondsia Chinese (Jojoba) Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Polyglyceryl-4 Olivate/Polyricinoleate, Elaeis Guineensis (Palm) Butter, Glyceryl Caprylate, Tapioca Starch, Polymethylsilsesquioxane, Tocopheryl Linoleate/Oleate, Cetearyl Alcohol, Water, Glyceryl Undecylenate, Hippophae Rhamnoides Fruit Oil, Tremella Fuciformis Sporocarp (Silver Ear Mushroom) Extract, Curcuma Longa (Turmeric) Root Extract, Ceramide NP, Bisabolol, Haematococcus Pluvialis Algae Extract."
      ],
      "other_safety_information": [
        "Other Information Protect this product from excessive heat and direct sun."
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Hydrating Sun Balm. SPF 50. Broad Spectrum. Face & Lip Protector. Mineral Zinc Oxide, ceramide NP, snow mushroom, sea buckthorn, jojoba oil, vitamin E, astaxanthin. Utu Hydrating Sun Balm carton label"
      ],
      "set_id": "59d1d0ac-2444-d6f9-e063-6294a90ae80c",
      "id": "5a202afd-9ad5-f139-e063-6394a90aaefb",
      "effective_time": "20260828",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Utu Hydrating Sun Balm Broad Spectrum SPF 50"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Utu Co"
        ],
        "product_ndc": [
          "87952-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "5a202afd-9ad5-f139-e063-6394a90aaefb"
        ],
        "spl_set_id": [
          "59d1d0ac-2444-d6f9-e063-6294a90ae80c"
        ],
        "package_ndc": [
          "87952-003-01",
          "87952-003-02",
          "87952-003-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}