{
  "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": [
        "PRO-TECT SUNSCREEN FOR PROFESSIONALS Meradimate, Octinoxate, Octisalate, Oxybenzone OCTINOXATE OCTINOXATE MERADIMATE MERADIMATE OXYBENZONE OXYBENZONE WATER ALOE VERA LEAF LANOLIN IODOPROPYNYL BUTYLCARBAMATE STEARIC ACID MINERAL OIL TALC TROLAMINE BENZYL ALCOHOL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYL ALCOHOL CETYL DIMETHICONE 45 DIAZOLIDINYL UREA DIETHANOLAMINE CETYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- EICOSYL POVIDONE OCTISALATE OCTISALATE"
      ],
      "active_ingredient": [
        "Active ingredients Meradimate 5.0% Octinoxate 7.5% Octisalate 5.0% Oxybenzone 5.0%"
      ],
      "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. • Stop use and ask a doctor if rash occurs. • 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 right away."
      ],
      "dosage_and_administration": [
        "Directions • apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor • Sun protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protections measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sun-glasses"
      ],
      "other_safety_information": [
        "Other Information • protect this product from excessive heat and direct sun."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aloe Vera Leaf, Benzyl Alcohol, C18-36 Acid Glycol Ester, Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked), Cetyl Alcohol, Cetyl Dimethicone 45, Diazolidinyl Urea, Diethanolamine Cetyl Phosphate, dl-Alpha Tocopheryl Acetate, Eicosyl Povidone, Iodopropynyl Butylcarbamate, Lanolin, Mineral Oil, Stearic Acid, Talc, Trolamine, Water."
      ],
      "questions": [
        "Questions or Comments 281-835-8051 | Bio-Med & Pharm. Mfg. Corp."
      ],
      "recent_major_changes": [
        "uses 06/2021 directions 06/2021"
      ],
      "keep_out_of_reach_of_children": [
        ""
      ],
      "package_label_principal_display_panel": [
        "Package label SUNSCREEN FOR PROFESSIONALS PRO-SPECTRUM PROCESS BROAD-SPECTRUM UVA/UVB SUNSCREEN PRO-TECT Water-Resistant Fragrance-Free Aloe & vitamin E spf 30"
      ],
      "set_id": "374e172b-90e8-4fca-8934-dee3ed7b599d",
      "id": "450fca6c-31a2-cde7-e063-6394a90a30c8",
      "effective_time": "20251203",
      "version": "15",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "PRO-TECT SUNSCREEN FOR PROFESSIONALS"
        ],
        "generic_name": [
          "MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE"
        ],
        "manufacturer_name": [
          "Bio-Medical & Pharmaceutical Manufacturing Corporation"
        ],
        "product_ndc": [
          "37945-860"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "CUTANEOUS"
        ],
        "substance_name": [
          "OCTINOXATE",
          "MERADIMATE",
          "OXYBENZONE",
          "OCTISALATE"
        ],
        "spl_id": [
          "450fca6c-31a2-cde7-e063-6394a90a30c8"
        ],
        "spl_set_id": [
          "374e172b-90e8-4fca-8934-dee3ed7b599d"
        ],
        "package_ndc": [
          "37945-860-64",
          "37945-860-65"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4Y5P7MUD51",
          "J9QGD60OUZ",
          "95OOS7VE0Y",
          "4X49Y0596W"
        ]
      }
    }
  ]
}