{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Avene Multi-Defense Fluid Zinc oxide MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL CAPRYLYL GLYCOL TOCOPHEROL TETRASODIUM GLUTAMATE DIACETATE ZINC OXIDE ZINC OXIDE TRIDECYL SALICYLATE NYLON-12 NIACINAMIDE METHYLPROPANEDIOL SILICON DIOXIDE ALLANTOIN STEARALKONIUM HECTORITE WATER JOJOBA OIL, RANDOMIZED POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE GLYCERIN SODIUM CHLORIDE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE LEVOMENOL RICE BRAN SOYBEAN LECITHIN PHENYLPROPANOL ROSEMARY POLYGLYCERYL-3 DIISOSTEARATE SODIUM HYDROXIDE ALKYL (C12-15) BENZOATE COCO-CAPRYLATE POLYGLYCERYL-3 PENTARICINOLEATE HELIANTHUS ANNUUS FLOWERING TOP"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information • Protect this product in this container from excessive heat and direct sun."
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 12%"
      ],
      "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."
      ],
      "do_not_use": [
        "Do not use • on broken skin."
      ],
      "ask_doctor": [
        "Stop use and ask a doctor if • rash occurs."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, call a poison control center or get medical help right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 months and older: • Apply generously 15 minutes before sun exposure • Reapply: • at least every 2 hours • after 40 minutes of swimming or sweating • immediately after towel drying • Children under 6 months of age: Ask a doctor • 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 spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. to 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Tridecyl Salicylate, Nylon-12, Niacinamide, Methylpropanediol, Silica, Glycerin, Sodium Chloride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Lecithin, Stearalkonium Hectorite, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Helianthus Annuus (Sun‑ower) Extract, Tocopherol, Rosmarinus Of­cinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide."
      ],
      "questions": [
        "Questions? 1-866-41-AVENE (28363)"
      ],
      "package_label_principal_display_panel": [
        "Box 338075 Box 338075"
      ],
      "set_id": "1329e56d-1e74-4bcc-e063-6394a90ae0c3",
      "id": "1329e56d-1e75-4bcc-e063-6394a90ae0c3",
      "effective_time": "20240308",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Avene Multi-Defense Fluid"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Pierre Fabre USA Inc."
        ],
        "product_ndc": [
          "64760-778"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "1329e56d-1e75-4bcc-e063-6394a90ae0c3"
        ],
        "spl_set_id": [
          "1329e56d-1e74-4bcc-e063-6394a90ae0c3"
        ],
        "package_ndc": [
          "64760-778-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}