{
  "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": [
        "Dynamic Sunscreen Broad Spectrum SPF 55 Octinoxate and Zinc Oxide WATER ISOCETYL STEARATE SORBITOL CETOSTEARYL ALCOHOL CYCLOMETHICONE 5 GLYCERYL MONOSTEARATE PEG-100 STEARATE ALCOHOL OCTISALATE POLYOXYL 20 CETOSTEARYL ETHER .ALPHA.-TOCOPHEROL ACETATE VINYLPYRROLIDONE/EICOSENE COPOLYMER HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) ETHYLHEXYLGLYCERIN BETULA PUBESCENS BARK GARDEN CRESS SPROUT SAGE COLA ACUMINATA SEED CAMELLIA OLEIFERA LEAF ALOE VERA LEAF XANTHAN GUM ISOMALT EDETATE DISODIUM ANHYDROUS TRIETHOXYCAPRYLYLSILANE SODIUM BENZOATE ZINC OXIDE ZINC OXIDE CAPRYLYL GLYCOL PHENOXYETHANOL OCTINOXATE OCTINOXATE"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENTS Octinoxate 7.5% Zinc Oxide 4.8%"
      ],
      "purpose": [
        "PURPOSE Sunscreen"
      ],
      "indications_and_usage": [
        "USES Help prevent sunburn."
      ],
      "warnings": [
        "WARNINGS For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use on damaged or 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 or irritation occurs."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "DIRECTIONS Apply liberally and evenly 15 minutes before sun exposure. For children under 6 months of age: Ask a doctor. Reapply: At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 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 spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone."
      ],
      "storage_and_handling": [
        "OTHER INFORMATION Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun."
      ],
      "package_label_principal_display_panel": [
        "Pura Vitale Professional Skincare Dynamic Sunscreen Broad Spectrum Sun Protection SPF 55 Sun Protection 4 fl oz (120ml) Pura Vitale Professional Skincare Dynamic Sunscreen Broad Spectrum Sun Protection SPF 55 Sun Protection 4 fl oz (120ml) Pura Vitale Professional Skincare Dynamic Sunscreen Broad Spectrum Sun Protection SPF 55 Sun Protection 4 fl oz (120ml)"
      ],
      "set_id": "c74440af-cbc0-7269-e053-2995a90a1426",
      "id": "c74440af-cbc1-7269-e053-2995a90a1426",
      "effective_time": "20210716",
      "version": "1",
      "openfda": {}
    }
  ]
}