{
  "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": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Johnsons Baby Care Essentials Gift Set Zinc Oxide Desitin Maximum Strength Zinc Oxide Diaper Rash Zinc Oxide PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PETROLATUM COD LIVER OIL LANOLIN STARCH, CORN GLYCERIN SORBITAN SESQUIOLEATE YELLOW WAX .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE Johnsons Head To Toe Wash WATER COCAMIDOPROPYL BETAINE PEG-80 SORBITAN LAURATE GLYCERIN PEG-150 PENTAERYTHRITYL TETRASTEARATE PPG-2 HYDROXYETHYL COCAMIDE PHENOXYETHANOL SODIUM METHYL COCOYL TAURATE SODIUM BENZOATE DECYL GLUCOSIDE CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN Johnsons Baby PHENOXYETHANOL POLYSORBATE 20 MAGNESIUM ALUMINUM SILICATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) P-ANISIC ACID SODIUM HYDROXIDE XANTHAN GUM ETHYLHEXYLGLYCERIN TITANIUM DIOXIDE WATER GLYCERIN ISOPROPYL PALMITATE STEARIC ACID GLYCERYL MONOSTEARATE CETYL ALCOHOL COCONUT OIL CETOSTEARYL ALCOHOL"
      ],
      "spl_unclassified_section": [
        "DESITIN Maximum Strength Zinc Oxide Diaper Rash Drug Facts",
        "Distributed by: Kenvue brands LLC Summit, NJ 07901"
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide (40%)"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses • helps treat and prevent diaper rash • protects chafed skin due to diaper rash and helps seal out wetness"
      ],
      "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 • change wet and soiled diapers promptly • cleanse the diaper area • allow to dry • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged"
      ],
      "storage_and_handling": [
        "Other information • store at 20°C to 25°C (68°F to 77°F) • may stain clothing"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Petrolatum, Cod Liver Oil, Lanolin, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopheryl Acetate, Fragrance"
      ],
      "questions": [
        "Questions? Call toll-free 800-720-3843 or 215-273-8755 (collect)"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - Kit Package Johnson’s® baby baby care essentials value pack all products are TSA compliant! Includes JOHNSON’S® baby lotion 3.4 FL OZ (100 mL) JOHNSON’S® HEAD-TO-TOE® wash & shampoo 3.4 FL OZ (100 mL) DESITIN® Maximum Strength Zinc Oxide Diaper Rash Paste 1 OZ (28 g). A selection of gentle products to cleanse, moisturize, and care for baby’s delicate skin Johnsons_01"
      ],
      "set_id": "1ac59efd-9efd-09d9-e063-6394a90a5e40",
      "id": "2c23de94-80b2-6435-e063-6394a90a3df5",
      "effective_time": "20250120",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Johnsons Baby Care Essentials Gift Set"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0894"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "1094560",
          "1797059"
        ],
        "spl_id": [
          "2c23de94-80b2-6435-e063-6394a90a3df5"
        ],
        "spl_set_id": [
          "1ac59efd-9efd-09d9-e063-6394a90a5e40"
        ],
        "package_ndc": [
          "69968-0894-9",
          "69968-0848-9"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0381371197569"
        ]
      }
    }
  ]
}