{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "1177, 1178 Sunscreen 1177, 1178 Sunscreen CARBOMER INTERPOLYMER TYPE A (55000 CPS) EDETATE DISODIUM DIMETHICONE 350 SORBITOL SOLUTION 70% TROLAMINE OCTINOXATE OCTINOXATE BUTYLATED HYDROXYANISOLE OXYBENZONE OXYBENZONE EICOSYL POVIDONE SORBITAN MONOSTEARATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE CETYL ALCOHOL WATER BUTYLATED HYDROXYTOLUENE PROPYLPARABEN STEARIC ACID POLYOXYL 20 CETOSTEARYL ETHER GLYCERYL STEARATE SE METHYLPARABEN"
      ],
      "active_ingredient": [
        "Active Ingredients Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses . Protects from excessive heat and direct sun . Helps prevent sunburns . Higher SPF gives more sunburn protection . For skin highly sensitive to sunburn"
      ],
      "warnings": [
        "Warnings For External Use Only. Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin carcer or early skin aging. Do not use On damaged or broken skin When using this product . Keep out of eyes . Rinse with water to remove Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 800-222-1222) 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"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions . Apply liberally 15 minutes before sun exposure . Reapply at least every 2 hours . Children under 6 months: as a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Antaron V-220, Butylated Hydroxyanisole, Butylated Hydroxytoluene, Carbopol Ultrez 10, Ceteareth 20, Cetyl Alcohol, Dimethicone 350, Edetate Disodium, Glyceryl Stearate SE, Methylparaben, Propylparaben, Purified Water, Sorbitan Monostearate, Sorbitol Solution, Stearic Acid, Trolamine"
      ],
      "questions": [
        "Questions? 1-888-DYNAREX Monday - Friday, 9AM - 5PM EST"
      ],
      "package_label_principal_display_panel": [
        "Label 1177 Sunscreen 1177 BX MASTER",
        "Label 1177, 1178 Sunscreen 1177-1178 DM MASTER"
      ],
      "set_id": "c3142ddb-74ea-a7d1-e053-2a95a90a26f3",
      "id": "2758c466-8d6c-3227-e063-6394a90ad9d1",
      "effective_time": "20241120",
      "version": "4",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "1177, 1178 Sunscreen"
        ],
        "generic_name": [
          "1177, 1178 SUNSCREEN"
        ],
        "manufacturer_name": [
          "Dynarex"
        ],
        "product_ndc": [
          "67777-177"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTINOXATE",
          "OXYBENZONE",
          "HOMOSALATE",
          "OCTISALATE"
        ],
        "spl_id": [
          "2758c466-8d6c-3227-e063-6394a90ad9d1"
        ],
        "spl_set_id": [
          "c3142ddb-74ea-a7d1-e053-2a95a90a26f3"
        ],
        "package_ndc": [
          "67777-177-11",
          "67777-177-01",
          "67777-177-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0616784117720"
        ],
        "unii": [
          "4Y5P7MUD51",
          "95OOS7VE0Y",
          "V06SV4M95S",
          "4X49Y0596W"
        ]
      }
    }
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}