{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "BRICKELL Element Defense Moisturizer SPF-45 OCTOCRYLENE, OCTISALATE, ZINC OXIDE ALOE VERA LEAF WATER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES WATERMELON DECYL GLUCOSIDE ETHYLHEXYLGLYCERIN GLYCERIN SUNFLOWER OIL C13-14 ISOPARAFFIN LAURETH-7 PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE TRIDECYL SALICYLATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE ZINC OXIDE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information: Protect the product in this container from excessive heat and direct sun."
      ],
      "active_ingredient": [
        "Active Ingredients Octocrylene 10.00% Octisalate 5.00% Zinc Oxide 5.00% Purpose Sunscreen"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses: Helps prevent sunburn. higher SPF gives more sunburn protection 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: not intended for ingestion 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 or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use."
      ],
      "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 or irritation develops and lasts."
      ],
      "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."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "dosage_and_administration": [
        "Directions: Apply liberally 15 minutes before sun exposure. Children under 6 months of age: ask a doctor. Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every2 hourr Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection SPF of 15 or higher, along with other sun protection measues including: SUN PROTECTION MEASURES: Limit time in the sun, especially between 10 am - 2 pm. Wear long-sleeve shirts, pants, hats and sunglasses."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citrullus Lantatus (Watermelon) Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, polyacrylamide, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate."
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "94be278a-3773-469b-8e40-3242d1072a3d",
      "id": "09e2e2ce-d877-0711-e063-6294a90a9213",
      "effective_time": "20231111",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "BRICKELL Element Defense Moisturizer SPF-45"
        ],
        "generic_name": [
          "OCTOCRYLENE, OCTISALATE, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "BRICKELL BRANDS LLC"
        ],
        "product_ndc": [
          "82247-234"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTOCRYLENE",
          "OCTISALATE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "09e2e2ce-d877-0711-e063-6294a90a9213"
        ],
        "spl_set_id": [
          "94be278a-3773-469b-8e40-3242d1072a3d"
        ],
        "package_ndc": [
          "82247-234-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850005016786"
        ],
        "unii": [
          "5A68WGF6WM",
          "4X49Y0596W",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}