{
  "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": "2026-10-29",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Aveeno Calm Plus Restore Skin Therapy Balm Colloidal Oatmeal BENZALKONIUM CHLORIDE OATMEAL OATMEAL SODIUM CHLORIDE PANTHENOL ISOPROPYL PALMITATE STEARETH-20 OAT KERNEL OIL CERAMIDE NP MEDIUM-CHAIN TRIGLYCERIDES OAT WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE DISTEARYLDIMONIUM PETROLATUM CETYL ALCOHOL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: Kenvue Brands LLC Summit, NJ 07901"
      ],
      "active_ingredient": [
        "Active ingredient Colloidal Oatmeal 1%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites"
      ],
      "warnings": [
        "Warnings For external use only When using this product Do not get into eyes 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. 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 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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Apply as needed."
      ],
      "storage_and_handling": [
        "Other information Do not use if quality seal is broken or missing. Store at Room Temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Caprylic/Capric Triglyceride, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Avena Sativa (Oat) Kernel Extract, Sodium Chloride"
      ],
      "questions": [
        "Questions? 866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 48g Tube Carton NEW ! Aveeno ® Calm + Restore SKIN THERAPY BALM Colloidal Oatmeal Skin Protectant Sensitive Skin Soothes and deeply moisturizes to help strengthen skin’s natural moisture barrier STEROID FREE FRAGRANCE-FREE DERMATOLOGIST RECOMMENDED BRAND COLLOIDAL OATMEAL + CERAMIDE net wt. 1.7 oz (48 g) Aveeno_1"
      ],
      "set_id": "dbe7a2cc-9c21-2a48-e053-2a95a90a54e2",
      "id": "36bdeede-e154-67e7-e063-6294a90ac506",
      "effective_time": "20250604",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Aveeno Calm Plus Restore Skin Therapy Balm"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0755"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240651"
        ],
        "spl_id": [
          "36bdeede-e154-67e7-e063-6294a90ac506"
        ],
        "spl_set_id": [
          "dbe7a2cc-9c21-2a48-e053-2a95a90a54e2"
        ],
        "package_ndc": [
          "69968-0755-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0381372022204"
        ],
        "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"
        ]
      }
    }
  ]
}