{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Avene Face Sunscreen SPF 50 Zinc oxide MEDIUM-CHAIN TRIGLYCERIDES ALKYL (C12-15) BENZOATE GLYCERYL MONOSTEARATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE LEVOMENOL PHENYLPROPANOL ALLANTOIN CAPRYLYL GLYCOL GLYCERYL MONOBEHENATE COCO-CAPRYLATE TETRASODIUM GLUTAMATE DIACETATE WATER TRIDECYL SALICYLATE HYDROGENATED SOYBEAN LECITHIN TOCOPHEROL ZINC OXIDE ZINC OXIDE SODIUM CHLORIDE POLYESTER-7 ISOAMYL LAURATE GLYCERYL DIBEHENATE FERRIC OXIDE RED PROPANEDIOL LECITHIN, SOYBEAN POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE SILICON DIOXIDE TRIBEHENIN SODIUM HYDROXIDE GLYCERIN POLYGLYCERYL-3 PENTARICINOLEATE SHEA BUTTER ETHYL ESTERS NEOPENTYL GLYCOL DIHEPTANOATE ALPHA-TOCOPHEROL ACETATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information • Protect the 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."
      ],
      "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, 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 80 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/Eau/Aqua, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Tridecyl Salicylate, Polyglyceryl-3 Polyricinoleate, Glyceryl Stearate, Shea Butter Ethyl Esters, Sodium Chloride, Polyester-7, Silica, Neopentyl Glycol Diheptanoate, Isoamyl Laurate, Polyglyceryl-2 Dipolyhydroxystearate, Glyceryl Dibehenate, Bisabolol, Phenylpropanol, Iron Oxides, Propanediol, Lecithin, Tribehenin, Allantoin, Caprylyl Glycol,Glyceryl Behenate, Coco-Caprylate, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Hydrogenated Lecithin, Sodium Hydroxide, Tocopherol."
      ],
      "questions": [
        "Questions? 1-866-41-AVENE (28363) 1-877-441-2011 (CAN)"
      ],
      "package_label_principal_display_panel": [
        "Box 337120 Box 337120"
      ],
      "set_id": "132ce436-a783-2ba0-e063-6394a90a4b70",
      "id": "132ce436-a784-2ba0-e063-6394a90a4b70",
      "effective_time": "20240308",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Avene Face Sunscreen SPF 50"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Pierre Fabre USA Inc."
        ],
        "product_ndc": [
          "64760-782"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "132ce436-a784-2ba0-e063-6394a90a4b70"
        ],
        "spl_set_id": [
          "132ce436-a783-2ba0-e063-6394a90a4b70"
        ],
        "package_ndc": [
          "64760-782-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}