{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 252
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Baby XtraCare Oatmeal Dimethicone WATER PETROLATUM MINERAL OIL GLYCERIN GLYCERYL MONOSTEARATE PROPYLENE GLYCOL PEG-100 STEARATE POLYACRYLAMIDE (10000 MW) CETYL ALCOHOL AVENA SATIVA WHOLE DMDM HYDANTOIN STEARYL ALCOHOL C13-14 ISOPARAFFIN LAURETH-7 EDETATE DISODIUM ALOE VERA LEAF METHYLPARABEN PROPYLPARABEN DIMETHICONE DIMETHICONE"
      ],
      "active_ingredient": [
        "Active Ingredient Purpose Dimethicone 1.2% ............................ Skin Protectant"
      ],
      "purpose": [
        "Use Help prevent and temporarily protects chafed, chapped, or cracked skin."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "indications_and_usage": [
        "Baby XtraCare® Oatmeal Daily Moisturizing Lotion Lightly Scented Dimethicon Skin Protectant with Natural Oat Extract Helps Soothe & Soften Baby's Skin 12 FL OZ (354 mL)"
      ],
      "dosage_and_administration": [
        "Directions Apply liberally as often as needed."
      ],
      "warnings": [
        "Warnings For extenal use only. When using this product avoid contact with eyes. In case of eye contact, flush with water. Stop use and ask a doctor if condition worsens. Symptoms last more than 7days or clear up and occur again within a few days."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients water, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben."
      ],
      "other_safety_information": [
        "Other Information Store at room temperature. Questions/Comments? 1-855-345-5575 DISTRIBUTED BY REJOICE INTERNATIONAL INC NORTHVILLE, MI 48168 U.S.A. MADE IN CHINA"
      ],
      "package_label_principal_display_panel": [
        "8oz label image 12oz label image"
      ],
      "set_id": "0049462b-ff31-440f-9244-b61153625bca",
      "id": "2c6a4461-23ef-636b-e063-6294a90a1f2a",
      "effective_time": "20250123",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Baby XtraCare Oatmeal"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Rejoice International"
        ],
        "product_ndc": [
          "57337-070"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "876980"
        ],
        "spl_id": [
          "2c6a4461-23ef-636b-e063-6294a90a1f2a"
        ],
        "spl_set_id": [
          "0049462b-ff31-440f-9244-b61153625bca"
        ],
        "package_ndc": [
          "57337-070-01",
          "57337-070-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0849607058317",
          "0849607058348"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}