{
  "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,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Nivea Smoothness Lip Care Avobenzone,Octocrylene OCTYLDODECANOL CASTOR OIL GLYCERIN YELLOW WAX SHEA BUTTER WATER POLYGLYCERYL-3 DIISOSTEARATE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE TOCOPHEROL ASCORBYL PALMITATE SUNFLOWER OIL HYDROGENATED CASTOR OIL HELIANTHUS ANNUUS SEED WAX"
      ],
      "active_ingredient": [
        "Active ingredients: Avobenzone 2.5 Octocrylene 7%"
      ],
      "purpose": [
        "Purpose: Sunscreen"
      ],
      "indications_and_usage": [
        "Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun"
      ],
      "warnings": [
        "Warnings: For external use only"
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs"
      ],
      "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": [
        "For sunscreen use apply liberally at least 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every two hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad SpectrumSPFvalue of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m. – 2 p.m. •wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients: Octyldodecanol, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Wax, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-3 Diisostearate, Hydrogenated Castor Oil, Glycerin, Tocopherol, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Water, Flavor."
      ],
      "questions": [
        "Questions? 1-800-227-4703"
      ],
      "package_label_principal_display_panel": [
        "NIVEA Smoothness Lip Care Broad spectrum SPF 15 3X Care: 1. MOISTURE 2. REPAIR+ 3. SUNSCREEN with Nourishing Oils, Vitamin C & E & ethically sourced Shea Butter* +FOR DRY LIPS smoothnesscardwif"
      ],
      "set_id": "c28e327d-ad39-9bd6-e053-2a95a90a04eb",
      "id": "474adb10-a17f-2c51-e063-6394a90a31f0",
      "effective_time": "20251231",
      "version": "5",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Nivea Smoothness Lip Care"
        ],
        "generic_name": [
          "AVOBENZONE,OCTOCRYLENE"
        ],
        "manufacturer_name": [
          "Beiersdorf Inc"
        ],
        "product_ndc": [
          "10356-819"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "AVOBENZONE",
          "OCTOCRYLENE"
        ],
        "spl_id": [
          "474adb10-a17f-2c51-e063-6394a90a31f0"
        ],
        "spl_set_id": [
          "c28e327d-ad39-9bd6-e053-2a95a90a04eb"
        ],
        "package_ndc": [
          "10356-819-25",
          "10356-819-41"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "G63QQF2NOX",
          "5A68WGF6WM"
        ]
      }
    }
  ]
}