{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30 OCTINOXATE, ZINC OXIDE BUTYLOCTYL SALICYLATE CAMELLIA OLEIFERA LEAF MEDIUM-CHAIN TRIGLYCERIDES CYCLOPENTASILOXANE DIMETHICONE EDETATE DISODIUM ETHYLHEXYLGLYCERIN GLYCERIN 1,2-HEXANEDIOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE NIACINAMIDE OCTYLDODECYL NEOPENTANOATE OLETH-10 PHENOXYETHANOL POLYACRYLATE-13 POLYSORBATE 20 POLYSORBATE 60 SODIUM HYALURONATE SORBITAN ISOSTEARATE .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE WATER XANTHAN GUM OCTINOXATE ETHYLHEXYL METHOXYCINNAMATE ZINC OXIDE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information protect the product in this container from excessive heat and direct sun"
      ],
      "active_ingredient": [
        "Active ingredient Octinoxate 7.50% Zinc Oxide 18.50% Purpose Sunscreen"
      ],
      "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 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 occurs Keep out of reach of children. If 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 occurs"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Butyloctyl Salicylate, Camellia Oleifera Leaf Extract, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, 1,2-Hexanediol, Hydrogenated Polyisobutene, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides (CI 77491, CI 77492, CI 77499), Niacinamide, Octyldodecyl Neopentanoate, Oleth-10, Phenoxyethanol, Polyacrylate-13, Polyglyceryl-3 Polyricinoleate, Polyisobutene, Polysorbate 20, Polysorbate 60, Sodium Hyaluronate, Sorbitan Isostearate, Tocopheryl Acetate, Triethoxycaprylylsilane, Water (Aqua), Xanthan Gum."
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "86dbd8c3-e95a-49a8-afe6-ff9d985e28ba",
      "id": "35b5a241-29c8-3db5-e063-6394a90aec16",
      "effective_time": "20250527",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30"
        ],
        "generic_name": [
          "OCTINOXATE, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "SOLVADERM LLC"
        ],
        "product_ndc": [
          "84197-967"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTINOXATE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "35b5a241-29c8-3db5-e063-6394a90aec16"
        ],
        "spl_set_id": [
          "86dbd8c3-e95a-49a8-afe6-ff9d985e28ba"
        ],
        "package_ndc": [
          "84197-967-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4Y5P7MUD51",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}