{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Whipped Gel Colloidal Oatmeal CETEARYL OLIVATE SORBITAN OLIVATE FUCUS VESICULOSUS SORBITAN MONOPALMITATE LACTIC ACID SUNFLOWER OIL SHEA BUTTER ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) INULIN PHENOXYETHANOL CETYL PALMITATE LECITHIN, SOYBEAN XANTHAN GUM BETASIZOFIRAN PULLULAN WATER PROPANEDIOL GLYCERIN SILICON DIOXIDE ALLANTOIN ETHYLHEXYLGLYCERIN CYANOCOBALAMIN OATMEAL OATMEAL"
      ],
      "spl_unclassified_section": [
        "OCEAN OLIVE Whipped Gel Nourishing Eczema Spot Treatment Skin Protectant Accepted National Eczema Association 1.7 oz / 50 ml"
      ],
      "active_ingredient": [
        "Colloidal Oatmeal 0.1%"
      ],
      "purpose": [
        "Skin Protectant"
      ],
      "indications_and_usage": [
        "temporarily protects and helps relieve minor skin irritation and itching due to eczema"
      ],
      "warnings": [
        "For external use only. When using this product do not get into eyes. Stop use and consult a doctor if conditions worsen symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product do not get into eyes."
      ],
      "stop_use": [
        "Stop use and consult a doctor if conditions worsen 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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions apply as needed."
      ],
      "inactive_ingredient": [
        "Water, Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Cetearyl Olivate, Sorbitan Olivate, Butyspermum Parkii (Shea) Butter, Sodium Acrylates Copolymer, Glycerin, Inulin, Fucus Vesiculosis (Bladderwrack) Extract, Cetyl Palmitate, Sorbitan Palmitate, Lecithin, Allantoin, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Lactic Acid, Sclerotium Gum, Cyanocobalamin, Pullulan, Silica."
      ],
      "questions": [
        "Questions or comments? Call toll free 1-800-484-9354 M-F 8am-5pm CST www.ocean-olive.com"
      ],
      "recent_major_changes": [
        "Mislabeled section"
      ],
      "package_label_principal_display_panel": [
        "Ocean Olive Whipped Gel"
      ],
      "set_id": "222b381c-665e-177d-e063-6394a90a3306",
      "id": "222b381c-665f-177d-e063-6394a90a3306",
      "effective_time": "20240915",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Whipped Gel"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "OCEAN OLIVE LLC"
        ],
        "product_ndc": [
          "84293-010"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "spl_id": [
          "222b381c-665f-177d-e063-6394a90a3306"
        ],
        "spl_set_id": [
          "222b381c-665e-177d-e063-6394a90a3306"
        ],
        "package_ndc": [
          "84293-010-01",
          "84293-010-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "8PI54V663Y"
        ]
      }
    }
  ]
}