{
  "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": [
        "TONEfitSUN Sebum Control Vegan Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene C12-15 ALKYL BENZOATE MICROCRYSTALLINE WAX BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE TRIETHOXYCAPRYLYLSILANE 1,2-HEXANEDIOL DIBUTYL ADIPATE BUTYLOCTYL SALICYLATE VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER SILICON DIOXIDE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE VP/HEXADECENE COPOLYMER ALPHA-TOCOPHEROL ACETATE PANTHENOL"
      ],
      "active_ingredient": [
        "Active ingredients Avobenzone 2.7% Homosalate 13.5% Octisalate 4.5% Octocrylene 9.5%"
      ],
      "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."
      ],
      "dosage_and_administration": [
        "Directions • apply liberally 15 minutes before sun exposure • 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 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.- 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses"
      ],
      "other_safety_information": [
        "Other Information • Protect this product from excessive heat and direct sun"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Dibutyl Adipate, Butyloctyl Salicylate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Silica, Synthetic Wax, C12-15 Alkyl Benzoate, Polyester-8, Butylene Glycol Dicaprylate/Dicaprate, VP/Hexadecene Copolymer, Synthetic Fluorphlogopite, Microcrystalline Wax, 1,2-Hexanediol, Caprylic/Capric Glycerides, Fragrance(Parfum), Triethoxycaprylylsilane, Tocopheryl Acetate, Panthenol"
      ],
      "package_label_principal_display_panel": [
        "Carton Image"
      ],
      "set_id": "506b96ae-eb2a-edad-e063-6294a90a470e",
      "id": "506b8ae9-30a9-7e7e-e063-6394a90aa9eb",
      "effective_time": "20260427",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "TONEfitSUN Sebum Control Vegan Sunscreen"
        ],
        "generic_name": [
          "AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE"
        ],
        "manufacturer_name": [
          "Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory"
        ],
        "product_ndc": [
          "58544-160"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTOCRYLENE",
          "AVOBENZONE",
          "HOMOSALATE",
          "OCTISALATE"
        ],
        "spl_id": [
          "506b8ae9-30a9-7e7e-e063-6394a90aa9eb"
        ],
        "spl_set_id": [
          "506b96ae-eb2a-edad-e063-6294a90a470e"
        ],
        "package_ndc": [
          "58544-160-01",
          "58544-160-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5A68WGF6WM",
          "G63QQF2NOX",
          "V06SV4M95S",
          "4X49Y0596W"
        ]
      }
    }
  ]
}