{
  "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": [
        "Barrier Cream ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES COCONUT OIL YELLOW WAX CANDELILLA WAX JOJOBA OIL TOCOPHEROL OLEA EUROPAEA LEAF ORANGE PEEL WAX ASTAXANTHIN BENTONITE CETEARYL OLIVATE SORBITAN OLIVATE PROPOLIS WAX LAVENDER OIL ROSEMARY ALOE VERA WHOLE ST. JOHN'S WORT CHAMOMILE LICORICE CALENDULA OFFICINALIS FLOWER MANUKA OIL PEPPERMINT OIL ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active Ingredients Zinc Oxide (Non-nano) 10%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness. Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin."
      ],
      "warnings": [
        "Warnings For external use only Avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor Condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Do not use: if allergic to ingredients. on deep or puncture wounds on animal bites •on serious burns. Test small area first. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "stop_use": [
        "Stop use and ask a doctor Condition worsens symptoms last for more than 7 days or clear up and occur again within a few days"
      ],
      "do_not_use": [
        "Do not use: if allergic to ingredients. on deep or puncture wounds on animal bites •on serious burns. Test small area first."
      ],
      "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, directly on skin as needed. Safe to apply to prosthetics, protective equipment, etc."
      ],
      "recent_major_changes": [
        ""
      ],
      "inactive_ingredient": [
        "Inactive ingredients *Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic"
      ],
      "other_safety_information": [
        "Other information store product between 45 to 100F Gently warm or knead product as needed to soften before use."
      ],
      "questions": [
        "Questions? Call 888-805-1507 or visit www.avasol.com"
      ],
      "package_label_principal_display_panel": [
        "Avasol Barrier Cream"
      ],
      "set_id": "bc6a2736-faa6-46d3-af9b-a70f0762e9ce",
      "id": "fbc1e407-09f5-1d83-e053-6294a90aef0f",
      "effective_time": "20230515",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Barrier Cream"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Avasol LLC"
        ],
        "product_ndc": [
          "58518-040"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "fbc1e407-09f5-1d83-e053-6294a90aef0f"
        ],
        "spl_set_id": [
          "bc6a2736-faa6-46d3-af9b-a70f0762e9ce"
        ],
        "package_ndc": [
          "58518-040-02",
          "58518-040-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}