{
  "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": [
    {
      "effective_time": "20181210",
      "inactive_ingredient": [
        "Inactive ingredients Purified Water, Cyclomethicone, C12-15 Alkyl Lactate, Butyloctyl Salicylate, Glyceryl Stearate SE, Isododecane, Glycerin, Cetearyl Alcohol, Butylene/Ethylene/Propylene Copolymer, Polyacrylamide, Cetyl Alcohol, Dicetyl Phosphate, Ceteth-10 Phosphate, Cholesterol, Tocopheryl Acetate, Edetate Disodium, Methylparaben, Phenoxyethanol, Xanthan Gum, Camellia Sinensis Leaf (Green Tea) Extract, Camellia Sinensis Leaf (White Tea) Extract, C13-C14 Isoparaffin, Laureth-7."
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "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."
      ],
      "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 product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product keep out of eyes. Rinse with water to remove."
      ],
      "questions": [
        "Questions or comments? call 1-973-882-7512"
      ],
      "spl_product_data_elements": [
        "Niseko Sunscreen SPF 25 Avobenzone, Octinoxate, and Octisalate Avobenzone Avobenzone Octinoxate Octinoxate Octisalate Octisalate water C12-15 Alkyl lactate butyloctyl salicylate Glyceryl Stearate SE isododecane glycerin cetostearyl alcohol cetyl alcohol dihexadecyl phosphate ceteth-10 phosphate cholesterol .alpha.-tocopherol acetate edetate disodium methylparaben phenoxyethanol xanthan gum green tea leaf C13-14 isoparaffin Laureth-7"
      ],
      "openfda": {},
      "version": "2",
      "dosage_and_administration": [
        "Directions apply liberally 15 minutes before sun exposure apply to all skin exposed to the sun reapply: at least every 2 hours use 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 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 children under 6 months: Ask a doctor"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Mfd. by: IGI Laboratories, Inc., Buena, NJ 08310"
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs"
      ],
      "storage_and_handling": [
        "Other information protect product from excessive heat and direct sun"
      ],
      "do_not_use": [
        "Do not use on damaged or broken skin"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 85 g Tube Carton niseko ® SUNSCREEN Broad Spectrum SPF 25 UVA/UVB Protection Formulated with Green & White Tea • Vitamin E Dermatologist-tested Non-comedogenic Net Wt. 3 oz (85 g) MEDIMETRIKS PHARMACEUTICALS, INC. Principal Display Panel - 85 g Tube Carton"
      ],
      "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"
      ],
      "set_id": "b782e60f-ab5f-4e71-a3d5-76c8367487c4",
      "id": "e81419d5-5f8b-43a6-9b1e-c57eb03a916e",
      "active_ingredient": [
        "Active Ingredient Avobenzone 3.0% Octinoxate 7.5% Octisalate 5.0%"
      ]
    }
  ]
}