{
  "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": [
        "SPF 50 MINERAL SUNSCREEN LIP Zinc Oxide , Titanium Dioxide ZINC OXIDE ZINC OXIDE WATER PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) SORBITAN SESQUIOLEATE ISOPROPYL PALMITATE SILICON DIOXIDE ETHYLHEXYL PALMITATE TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) DISTEARDIMONIUM HECTORITE DIMETHICONE BUTYLENE GLYCOL TRIETHOXYCAPRYLYLSILANE TITANIUM DIOXIDE TITANIUM DIOXIDE ISOHEXADECANE GLYCERIN CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) SODIUM CHLORIDE PEG-30 DIPOLYHYDROXYSTEARATE TRIBEHENIN MAGNESIUM STEARATE PHENOXYETHANOL ETHYLHEXYLGLYCERIN"
      ],
      "active_ingredient": [
        "Zinc Oxide 4.85% Titanium Dioxide 8%"
      ],
      "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 agingcaused 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.lf swallowed, getmedical help or contact Posion Center right away."
      ],
      "dosage_and_administration": [
        "Directions ·Applyliberally15 minutes before sun exposure·Reapply:·after 80 minutes of swimming orsweating·after towel drying, swimming, or·at least every 2 hours ·children under 6 months of age: ask a doctor."
      ],
      "other_safety_information": [
        ".Protect this product from excessive heat and direct sun.Sun alert: Limiting sunexposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects ofthe sun."
      ],
      "inactive_ingredient": [
        "Water,Dimethicone, lsohexadecane, EthylhexylPalmitate, Butylene Glycol, Glycerin, lsopropyl PalmitateSorbitan Sesquioleate, Cetyl Peg/Ppg-10/ Dimethicone.Silica, Disteardimonium Hectorite, Sodium Chloride,Trimethylsiloxysilicate, Peg-30 Dipolyhydroxystearate, Tribehenin, Magnesium Stearate, Phenoxyethanol,Triethoxycaprylylsilane Ethylhexylglycerin, PentaerythrityTetra-Di-T-Buty Hydroxyhydrocinnamate"
      ],
      "questions": [
        "Please call:1-817-398-8817 or emus at info@redi-usa.com."
      ],
      "package_label_principal_display_panel": [
        "labeling"
      ],
      "set_id": "1c6f0964-9bee-1c06-e063-6294a90ac2a4",
      "id": "46872f1f-b25a-abbb-e063-6394a90a0e8f",
      "effective_time": "20251222",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "SPF 50 MINERAL SUNSCREEN LIP"
        ],
        "generic_name": [
          "ZINC OXIDE , TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "Guangzhou Tata Biotechnology Co., Ltd."
        ],
        "product_ndc": [
          "84066-104"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "46872f1f-b25a-abbb-e063-6394a90a0e8f"
        ],
        "spl_set_id": [
          "1c6f0964-9bee-1c06-e063-6294a90ac2a4"
        ],
        "package_ndc": [
          "84066-104-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "15FIX9V2JP"
        ]
      }
    }
  ]
}