{
  "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": [
        "celazome Moisturizing SPF 30 Active OXYBENZONE, OCTINOXATE, OCTISALATE, and HOMOSALATE OXYBENZONE OXYBENZONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE HOMOSALATE HOMOSALATE WATER DIOCTYL MALEATE ALCOHOL SORBITOL DIETHANOLAMINE CETYL PHOSPHATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE, UNSPECIFIED CETYL ALCOHOL TROLAMINE PROPYLPARABEN METHYLPARABEN"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Manufactured for Celazome ® by: Dermazone Solutions St. Petersburg, FL 33713"
      ],
      "active_ingredient": [
        "Active ingredients Benzophenone-3 5.0% Ethylhexyl Methoxycinnamate 7.5% Ethylhexyl Salicylate 5.0% Homosalate 5.0%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses helps prevent sunburn"
      ],
      "warnings": [
        "Warnings Skin Cancer/Skin Aging Alert 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 cancer or early skin aging. 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 occurs. Keep out of reach of children. If product is 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 occurs."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If product is 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 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients purifed water, sorbitol, dicaprylyl maleate, alcohol, potassium cetyl phosphate, lecithin, cetyl alcohol, dimethicone, tocopheryl acetate, aloe barbadensis leaf juice, carbomer, methylparaben, propylparaben, triethanolamine"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 113 g Bottle Carton celazome ® clinical skin care Moisturizing Sunscreen Clinical Skin Care with Lyphazome ® Technology SPF 30 ACTIVE SPORT WATER RESISTANT (80 MINUTES) 4 OZ (113 g) Principal Display Panel - 113 g Bottle Carton"
      ],
      "set_id": "5ec1510d-1465-4849-9e23-f16e11ff0e65",
      "id": "586f453e-4b57-49b8-8139-91fa03099f92",
      "effective_time": "20250725",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "celazome Moisturizing SPF 30 Active"
        ],
        "generic_name": [
          "OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE"
        ],
        "manufacturer_name": [
          "Dermazone LLC"
        ],
        "product_ndc": [
          "58466-901"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OXYBENZONE",
          "OCTINOXATE",
          "OCTISALATE",
          "HOMOSALATE"
        ],
        "spl_id": [
          "586f453e-4b57-49b8-8139-91fa03099f92"
        ],
        "spl_set_id": [
          "5ec1510d-1465-4849-9e23-f16e11ff0e65"
        ],
        "package_ndc": [
          "58466-901-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "95OOS7VE0Y",
          "4Y5P7MUD51",
          "4X49Y0596W",
          "V06SV4M95S"
        ]
      }
    }
  ]
}