{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "OUTER REEF MINERAL SUNSCREEN SPF 30 TITANIUM DIOXIDE ALOE VERA LEAF WATER BUTYLOCTYL SALICYLATE GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL CETEARYL OLIVATE CETYL PALMITATE WATERMELON COCONUT OIL CARROT DODECANE GLYCERIN GLYCERYL CAPRYLATE GLYCERYL MONOSTEARATE GLYCERYL 1-UNDECYLENATE HELIANTHUS ANNUUS FLOWERING TOP HYDROGENATED CASTOR OIL HYDROXYMETHYL CELLULOSE MAGNESIUM ALUMINUM SILICATE SILICON DIOXIDE SORBITAN OLIVATE STEARIC ACID TOCOPHEROL TRIDECYL SALICYLATE TITANIUM DIOXIDE TITANIUM DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information: • Protect this product from excessive heat and direct sunlight."
      ],
      "active_ingredient": [
        "Active Ingredient Titanium Dioxide 8.00% Purpose Sunscreen"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses: • Helps prevent sunburn • Higher SPF gives more sunburn protection • Retains SPF after 80 minutes of swimming or sweating • 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 not intended for ingestion. Do Not Use: • on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. • stop use and consult physician if irritation or rash develops. Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately."
      ],
      "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 and consult physician if irritation or rash develops."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately."
      ],
      "dosage_and_administration": [
        "Directions: • Apply liberally 15-minutes before sun exposure. • Children under 6-months of age: ask a doctor. • Reapply: -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures -Limit time in the sun, especially between 10am and 2pm. -Wear long sleeve shirts, pants, hats and sunglasses. Sun Protection Measures:"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: *Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Palmitate, Citrullus Lanatus (Watermelon) Extract, *Cocos Nucifera (coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, *Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, *Helianthus Annuus (Sunflower) Oil, Hydrogenated Castor Oil, Hydroxymethylcellulose, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Silica, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate. *Denotes certified organic ingredient."
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "86ee2fdf-8a88-44e6-b12a-36a92360477a",
      "id": "48c0bc5e-03f5-d430-e063-6394a90aac6b",
      "effective_time": "20260119",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "OUTER REEF MINERAL SUNSCREEN SPF 30"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "Coral Reef Park Co., Inc."
        ],
        "product_ndc": [
          "73691-047"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "48c0bc5e-03f5-d430-e063-6394a90aac6b"
        ],
        "spl_set_id": [
          "86ee2fdf-8a88-44e6-b12a-36a92360477a"
        ],
        "package_ndc": [
          "73691-047-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0722537977135"
        ],
        "unii": [
          "15FIX9V2JP"
        ]
      }
    }
  ]
}