{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Extreme Protect SPF 40 All Shades Zinc Oxide, Titanium Dioxide TITANIUM DIOXIDE TITANIUM DIOXIDE ETHYLHEXYLGLYCERIN ALOE VERA LEAF POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) WATER CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) XANTHAN GUM PHENOXYETHANOL ISOSTEARIC ACID EDETATE DISODIUM FERRIC OXIDE RED POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) GLYCERIN MAGNESIUM ALUMINUM SILICATE OLEYL ALCOHOL MADECASSIC ACID DIMETHICONE 100 FERRIC OXIDE YELLOW CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) FERROSOFERRIC OXIDE PANTHENOL TRIACETATE, (+)- ETHYL LINOLEATE ASIATICOSIDE ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES TOCOPHEROL SORBITAN MONOSTEARATE HEXYL LAURATE BUTYLENE GLYCOL PENTYLENE GLYCOL POLYGLYCERYL-4 ISOSTEARATE ALUMINUM STEARATE ALUMINUM OXIDE TRIDECETH-6 ZINC OXIDE ZINC OXIDE PROPYLENE GLYCOL ASIATIC ACID TRIBEHENIN OLEA EUROPAEA LEAF POLYHYDROXYSTEARIC ACID (2300 MW)"
      ],
      "active_ingredient": [
        "Zinc Oxide: 15.3% Titanium Dioxide: 1.3%"
      ],
      "purpose": [
        "Sunscreen"
      ],
      "indications_and_usage": [
        "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": [
        "For external use only."
      ],
      "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 product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am - 2pm. wear long-sleeve shirts, pants, hats, and sunglasses."
      ],
      "other_safety_information": [
        "Protect this product from excessive heat and direct sun."
      ],
      "questions": [
        "Call Customer Care at (888) 804 - 4447"
      ],
      "inactive_ingredient": [
        "Water/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients"
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "69219-108-21 5g 10 pack 69219-108-01 Bronze 100g bottle 69219-108-11 Beige Box 69219-108-01 Beige 100g bottle 69219-108-01 NT 100g bottle 69219-108-02 5g single 69219-108-11 NT Box 69219-108-11 Bronze 100g box 69219-108-03 69219-108-31"
      ],
      "set_id": "b69db78b-5f0e-8ca2-e053-2a95a90ac88c",
      "id": "2b4f67e8-6794-c22e-e063-6394a90ac9ac",
      "effective_time": "20250109",
      "version": "4",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Extreme Protect SPF 40 All Shades"
        ],
        "generic_name": [
          "ZINC OXIDE, TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "Science of Skincare, LLC."
        ],
        "product_ndc": [
          "69219-108"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "2b4f67e8-6794-c22e-e063-6394a90ac9ac"
        ],
        "spl_set_id": [
          "b69db78b-5f0e-8ca2-e053-2a95a90ac88c"
        ],
        "package_ndc": [
          "69219-108-01",
          "69219-108-11",
          "69219-108-02",
          "69219-108-21",
          "69219-108-03",
          "69219-108-31"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0817244011675",
          "0817244011668",
          "0817244011682"
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}