{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "IOPE UV DEFENSE SUN PROTECTOR Homosalate, Octocrylene, Octisalate, Avobenzone CETEARYL GLUCOSIDE SORBITAN ISOSTEARATE ANHYDROUS DEXTROSE OCTISALATE OCTISALATE .BETA.-CITRONELLOL, (R)- 1,2-HEXANEDIOL OCTOCRYLENE OCTOCRYLENE .ALPHA.-HEXYLCINNAMALDEHYDE PHENYL TRIMETHICONE CAPRYLYL TRISILOXANE WATER AVOBENZONE AVOBENZONE POTASSIUM CETYL PHOSPHATE SODIUM POLYACRYLOYLDIMETHYL TAURATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) ETHYLHEXYLGLYCERIN BUTYLENE GLYCOL GLYCERIN BUTYLOCTYL SALICYLATE TOCOPHEROL LINALOOL, (+/-)- EDETATE DISODIUM HOMOSALATE HOMOSALATE CETOSTEARYL ALCOHOL GLYCERYL CAPRYLATE LIMONENE, (+)- FERULIC ACID"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Avobenzone 2.5% Homosalate 9% Octisalate 4.5% Octocrylene 9%"
      ],
      "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 externel 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. 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."
      ],
      "storage_and_handling": [
        "Other information Protect the product in this container from excessive heat and direct sun. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun."
      ],
      "inactive_ingredient": [
        "Inactive ingredients WATER, BUTYLENE GLYCOL,GLYCERIN, BUTYLOCTYL SALICYLATE, CETEARYL ALCOHOL, PHENYL TRIMETHICONE, CAPRYLYL METHICONE, POTASSIUM CETYL PHOSPHATE, CETEARYL GLUCOSIDE, 1,2-HEXANEDIOL, SODIUM POLYACRYLOYLDIMETHYL, TAURATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, FRAGRANCE / PARFUM, TOCOPHEROL, GLYCERYL CAPRYLATE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, LIMONENE, SORBITAN ISOSTEARATE, LINALOOL, GLUCOSE, CITRONELLOL, HEXYL CINNAMAL, FERULIC ACID"
      ],
      "troubleshooting": [
        "Questions? support@us.amorepacific.com"
      ],
      "package_label_principal_display_panel": [
        "IOPE UV Defense Sun Protector Sunscreen IOPE UV DEFENSE SUN PROTECTOR SUNSCREEN BROAD SPECTRUM SPF45 50 mL / 1.69 fl. oz. pdp"
      ],
      "set_id": "0f2a87f7-2185-16a5-e063-6294a90a92a3",
      "id": "23f91031-feea-4c2e-e063-6294a90a3200",
      "effective_time": "20241008",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "IOPE UV DEFENSE SUN PROTECTOR"
        ],
        "generic_name": [
          "HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE"
        ],
        "manufacturer_name": [
          "AMOREPACIFIC CORPORATION"
        ],
        "product_ndc": [
          "43419-420"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTISALATE",
          "OCTOCRYLENE",
          "AVOBENZONE",
          "HOMOSALATE"
        ],
        "spl_id": [
          "23f91031-feea-4c2e-e063-6294a90a3200"
        ],
        "spl_set_id": [
          "0f2a87f7-2185-16a5-e063-6294a90a92a3"
        ],
        "package_ndc": [
          "43419-420-08"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4X49Y0596W",
          "5A68WGF6WM",
          "G63QQF2NOX",
          "V06SV4M95S"
        ]
      }
    }
  ]
}