{
  "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": [
        "CorTex SunX 50 Thick Avobenzone, Homosalate, Octisalate, Octocrylene PHENOXYETHANOL PROPYLENE GLYCOL ETHYLHEXYLGLYCERIN WATER THEOBROMA CACAO WHOLE SODIUM HYDROXIDE C12-20 ALKYL BENZOATE DISODIUM EDTA-COPPER METHYLCELLULOSE, UNSPECIFIED ACRYLATES CROSSPOLYMER-6 .ALPHA.-TOCOPHEROL ACETATE PEG-6 SORBITAN OLEATE ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE MEDIUM DENSITY POLYETHYLENE POLYSORBATE 20 HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE CorTex SunX 50 Thick Avobenzone, Homosalate, Octisalate, Octocrylene PHENOXYETHANOL PROPYLENE GLYCOL ETHYLHEXYLGLYCERIN WATER THEOBROMA CACAO WHOLE SODIUM HYDROXIDE C12-20 ALKYL BENZOATE DISODIUM EDTA-COPPER METHYLCELLULOSE, UNSPECIFIED ACRYLATES CROSSPOLYMER-6 .ALPHA.-TOCOPHEROL ACETATE PEG-6 SORBITAN OLEATE ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE MEDIUM DENSITY POLYETHYLENE POLYSORBATE 20 HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE"
      ],
      "active_ingredient": [
        "Active Ingredients: Avobenzone...3% Homosalate...10% Octisalate...5% Octocrylene...5%"
      ],
      "purpose": [
        "Purpose Sunscreen Sunscreen Sunscreen Sunscreen"
      ],
      "indications_and_usage": [
        "Uses: helps prevent sunburn. higher SPF gives more sunburn protection. retains SPF after 80 minutes of activity in the water or sweating. provides high protection against sunburn."
      ],
      "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 or irritation develops and lasts Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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."
      ],
      "dosage_and_administration": [
        "Directions: apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating after towel drying, swimming, or at least every 2 hours Children under 6 months of age: ask a doctor."
      ],
      "other_safety_information": [
        "Other Information: Protect this product from excessive heat and direct sun. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun."
      ],
      "inactive_ingredient": [
        "Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbedensis leaf juice, C12-15 alkyl benzoate,carbomer, disodium EDTA, ethylhexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol,polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan oleate, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water."
      ],
      "questions": [
        "Questions? Call: 1-877-684-5774"
      ],
      "spl_patient_package_insert": [
        "65753-603-09 604-09"
      ],
      "package_label_principal_display_panel": [
        "65753-602-24 602-24",
        "65753-602-22,-23,-26,and -31 602",
        "65753-603-03 604-03",
        "65753-603-22,-23,-24,-25,-26 603-22",
        "65753-603-10 604-10",
        "65753-603-35 604-35",
        "65753-603-02 604-02",
        "65753-603-01 604-01",
        "65753-603-33 604-33",
        "65753-603-07 604-07",
        "65753-603-05 604-05",
        "65753-603-04 604-04",
        "65753-603-34 604-34",
        "65753-603-32 604-32",
        "65753-603-39 603-39"
      ],
      "set_id": "f67a6c6c-c314-1c9d-e053-2a95a90a7f1a",
      "id": "4f1d54d8-37c3-ff62-e063-6394a90a458e",
      "effective_time": "20260410",
      "version": "6",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "CorTex SunX 50 Thick"
        ],
        "generic_name": [
          "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE"
        ],
        "manufacturer_name": [
          "CoreTex Products Inc"
        ],
        "product_ndc": [
          "65753-602",
          "65753-603"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HOMOSALATE",
          "OCTOCRYLENE",
          "OCTISALATE",
          "AVOBENZONE"
        ],
        "spl_id": [
          "4f1d54d8-37c3-ff62-e063-6394a90a458e"
        ],
        "spl_set_id": [
          "f67a6c6c-c314-1c9d-e053-2a95a90a7f1a"
        ],
        "package_ndc": [
          "65753-603-39",
          "65753-603-22",
          "65753-603-23",
          "65753-603-24",
          "65753-603-26",
          "65753-603-01",
          "65753-603-02",
          "65753-603-35",
          "65753-603-09",
          "65753-603-10",
          "65753-603-25",
          "65753-603-03",
          "65753-603-32",
          "65753-603-33",
          "65753-603-04",
          "65753-603-05",
          "65753-603-07",
          "65753-603-34",
          "65753-603-08",
          "65753-602-22",
          "65753-602-23",
          "65753-602-24",
          "65753-602-26",
          "65753-602-31"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0698229616722",
          "0698229616760",
          "0698229616678",
          "0698229616623",
          "0698229616654",
          "0698229617712",
          "0698229615572",
          "0698229616715",
          "0698229616685",
          "0698229616647",
          "0698229614339",
          "0698229616661",
          "0698229616005"
        ],
        "unii": [
          "5A68WGF6WM",
          "G63QQF2NOX",
          "4X49Y0596W",
          "V06SV4M95S"
        ]
      }
    }
  ]
}