{
  "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": [
        "Claravie Zinc Oxide, Dimethicone ZINC OXIDE ZINC OXIDE DIMETHICONE DIMETHICONE ALOE BARBADENSIS LEAF ALUMINUM STEARATE BEESWAX CHLOROXYLENOL CHOLECALCIFEROL CORN OIL ETHYLHEXYLGLYCERIN IMIDAZOLIDINYL UREA LANOLIN MINERAL OIL PARAFFIN PETROLATUM PHENOXYETHANOL PROPYLENE GLYCOL SORBITAN SESQUIOLEATE ALPHA-TOCOPHEROL ACETATE VITAMIN A PALMITATE WATER"
      ],
      "description": [
        "“Powered by nature, perfected by science—the ClaraVie™ skin care collection offers a harmonious blend of advanced technology and natural ingredients for radiant, healthy skin.”"
      ],
      "active_ingredient": [
        "Active Ingredient Zinc Oxide 12% w/w Dimethicone 1% w/w"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps prevent and protect protective undergarment rash. Protects minor skin irritation associated with protective undergarment rash and helps seal out wetness."
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children In case of accidental ingestion, contact a physician or Poison Control Center right away."
      ],
      "instructions_for_use": [
        "Directions Change wet and soiled protective undergarments promptly. Cleanse the protective undergarment area, and allow to dry. Apply cream liberally as often as necessary with each protective undergarment change, especially at bedtime or anytime when exposure to wet protective undergarments may be prolonged."
      ],
      "storage_and_handling": [
        "Other Information Store between 59°F–86°F (15°C–30°C)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Aloe Barbadensis Leaf Extract, Aluminum Stearate, Beeswax, Chloroxylenol, Cholecalciferol, Corn Oil, Ethylhexylglycerin, Fragrance, Imidazolidinyl Urea, Lanolin, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Propylene Glycol, Sorbitan Sesquioleate, Tocopherol Acetate, Vitamin A Palmitate, Water"
      ],
      "dosage_and_administration": [
        "Apply cream liberally as often as necessary with each protective undergarment change, especially at bedtime or anytime when exposure to wet protective undergarments may be prolonged."
      ],
      "questions": [
        "1-800-840-9041 www.gentell.com"
      ],
      "package_label_principal_display_panel": [
        "Advanced Barrier Cream Advance barrier Cream Label: AB Cream"
      ],
      "set_id": "598a5c0b-1e2f-1335-e063-6394a90ac4f4",
      "id": "598a5c0b-1e30-1335-e063-6394a90ac4f4",
      "effective_time": "20260821",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Claravie"
        ],
        "generic_name": [
          "ZINC OXIDE, DIMETHICONE"
        ],
        "manufacturer_name": [
          "Gentell LLC"
        ],
        "product_ndc": [
          "61554-312"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "DIMETHICONE"
        ],
        "rxcui": [
          "637565"
        ],
        "spl_id": [
          "598a5c0b-1e30-1335-e063-6394a90ac4f4"
        ],
        "spl_set_id": [
          "598a5c0b-1e2f-1335-e063-6394a90ac4f4"
        ],
        "package_ndc": [
          "61554-312-11"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "SOI2LOH54Z",
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}