{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Total Sun Protection Octinoxate, Octisalate, Oxybenzone, Zinc Oxide WATER ALOE VERA LEAF PPG-3 MYRISTYL ETHER GLYCOL STEARATE CETYL ALCOHOL POLYACRYLAMIDE (10000 MW) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) CAMELLIA OLEIFERA LEAF CAMELLIA SINENSIS WHOLE .ALPHA.-TOCOPHEROL ACETATE PROPYLENE GLYCOL C13-14 ISOPARAFFIN DECYL GLUCOSIDE SILICON DIOXIDE CETYL PHOSPHATE GLYCERYL MONOSTEARATE PEG-100 STEARATE GLYCERIN DIAZOLIDINYL UREA TRIETHOXYCAPRYLYLSILANE METHYLPARABEN EDETATE DISODIUM PROPYLPARABEN LAURETH-7 OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE ZINC OXIDE ZINC CATION"
      ],
      "active_ingredient": [
        "Active Ingredients Octinoxate 7.5% w/w Octisalate 3.0% w/w Oxybenzone 3.0% w/w Zinc Oxide 4.0% w/w"
      ],
      "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 doctor if rash occurs. Keep out of reach of children. If product is swalled, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions • Apply liberally 15 minutes before sun exposure and as needed • Reapply: • After 40 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 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 10am to 2pm • Wear long sleeve shirts, pants, hats, and sun glasses • Children under 6 months: Ask a doctor"
      ],
      "storage_and_handling": [
        "Other Information Protect this product from excessive heat and direct sun"
      ],
      "questions": [
        "Questions or Comments: Call 770-965-1022"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, PPG-3 Myristyl Ether, Aloe Barbadensis Leaf Extract, Glycol Stearate, Cetyl Alcohol, Polyacrylamide, PVP/Hexadecene Copolymer, White Tea (Camellia Oleisera) Leaf Extract, Green Tea (Camellia Sinensis) Leaf Extract, Tocopheryl Acetate, Propylene Glycol, C13-14 Isoparaffin, Decyl Glucoside, Silica, Cetyl Phosphate, Glyceryl Stearate, PEG 100 Stearate, Glycerin, Diazolidinyl Urea, Triethoxycaprylylsilane, Methylparaben, Disodium EDTA, Propylparaben, Laureth-7"
      ],
      "package_label_principal_display_panel": [
        "Label"
      ],
      "set_id": "dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f",
      "id": "43545da6-6e83-7dc3-e063-6294a90ab889",
      "effective_time": "20251111",
      "version": "7",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Total Sun Protection"
        ],
        "generic_name": [
          "OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Cosmed Dermaceuticals, Inc."
        ],
        "product_ndc": [
          "61352-004"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTINOXATE",
          "OCTISALATE",
          "OXYBENZONE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "43545da6-6e83-7dc3-e063-6294a90ab889"
        ],
        "spl_set_id": [
          "dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f"
        ],
        "package_ndc": [
          "61352-004-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4Y5P7MUD51",
          "4X49Y0596W",
          "95OOS7VE0Y",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}