{
  "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 Hydrance Moisturizing SPF 30 Zinc oxide TRIDECYL SALICYLATE COCO-CAPRYLATE C13-15 ALKANE DISTEARDIMONIUM HECTORITE SILICON DIOXIDE CAPRYLYL GLYCOL SODIUM CHLORIDE WATER TOCOPHEROL METHYLPROPANEDIOL SHEA BUTTER ETHYL ESTERS PROPANEDIOL POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE ZINC OXIDE ZINC OXIDE GLYCERIN POLYGLYCERYL-3 PENTARICINOLEATE APPLE ALLANTOIN PHENYLPROPANOL TETRASODIUM GLUTAMATE DIACETATE SODIUM HYDROXIDE TRIDECANE MEDIUM-CHAIN TRIGLYCERIDES UNDECANE ISOAMYL LAURATE LEVOMENOL LECITHIN, SOYBEAN ALOE VERA LEAF"
      ],
      "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 10%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses • helps prevent sunburn."
      ],
      "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 • Use a water resistant sunscreen if swimming or sweating • 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, Tridecyl Salicylate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Propanediol, Coco-Caprylate, C13-15 Alkane, Glycerin, Undecane, Methylpropanediol, Polyglyceryl-3 Polyricinoleate, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Disteardimonium Hectorite, Isoamyl Laurate, Silica, Tridecane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Allantoin, Lecithin, Aloe Barbadensis Leaf Juice Powder, Phenylpropanol, Tetrasodium Glutamate Diacetate, Tocopherol, Sodium Hydroxide."
      ],
      "questions": [
        "Questions? 1-866-41-AVENE (28363) 1-877-441-2011 (CAN)"
      ],
      "package_label_principal_display_panel": [
        "Box 336505 Box 336505"
      ],
      "set_id": "1361ebe5-2659-d88f-e063-6294a90a71bb",
      "id": "1361ebe5-265a-d88f-e063-6294a90a71bb",
      "effective_time": "20240311",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Avene Hydrance Moisturizing SPF 30"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Pierre Fabre USA Inc."
        ],
        "product_ndc": [
          "64760-783"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "1361ebe5-265a-d88f-e063-6294a90a71bb"
        ],
        "spl_set_id": [
          "1361ebe5-2659-d88f-e063-6294a90a71bb"
        ],
        "package_ndc": [
          "64760-783-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}