{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Avene Multi-Defense Fluid Tinted Zinc oxide POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE NYLON-12 ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES SILICON DIOXIDE COCO-CAPRYLATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE ALLANTOIN HYDROGENATED SOYBEAN LECITHIN ALUMINUM HYDROXIDE TOCOPHEROL ROSEMARY STEARALKONIUM HECTORITE PHENYLPROPANOL TETRASODIUM GLUTAMATE DIACETATE WATER PROPANEDIOL TRIDECYL SALICYLATE JOJOBA OIL, RANDOMIZED ALKYL (C12-15) BENZOATE NIACINAMIDE TITANIUM DIOXIDE FERRIC OXIDE RED GLYCERIN SODIUM CHLORIDE LECITHIN, SOYBEAN POLYGLYCERYL-3 DIISOSTEARATE POLYGLYCERYL-3 PENTARICINOLEATE HELIANTHUS ANNUUS FLOWERING TOP SODIUM HYDROXIDE LEVOMENOL METHYLPROPANEDIOL CAPRYLYL GLYCOL RICE BRAN"
      ],
      "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."
      ],
      "when_using": [
        "When using this product • keep out of eyes. Rinse with water to remove."
      ],
      "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, Caprylic/Capric Triglyceride, Jojoba Esters, C12-15 Alkyl Benzoate, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Tridecyl Salicylate, Nylon-12, Niacinamide, Methylpropanediol, Titanium Dioxide, Iron Oxides, 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 (Sunflower) Extract, Hydrogenated Lecithin, Aluminum Hydroxide, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide."
      ],
      "questions": [
        "Questions? 1-866-41-AVENE (28363)"
      ],
      "package_label_principal_display_panel": [
        "Box 338079 Box 338079"
      ],
      "set_id": "132bdf9a-c5d0-e7e5-e063-6394a90a6180",
      "id": "132bdf9a-c5d1-e7e5-e063-6394a90a6180",
      "effective_time": "20240308",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Avene Multi-Defense Fluid Tinted"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Pierre Fabre USA Inc."
        ],
        "product_ndc": [
          "64760-779"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "132bdf9a-c5d1-e7e5-e063-6394a90a6180"
        ],
        "spl_set_id": [
          "132bdf9a-c5d0-e7e5-e063-6394a90a6180"
        ],
        "package_ndc": [
          "64760-779-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}