{
  "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": [
        "Tinted Lip Cream SPF 15 ZINC OXIDE POLYGLYCERYL-4 ISOSTEARATE STEARALKONIUM HECTORITE PROPYLENE CARBONATE KAOLIN DEHYDROACETIC ACID DIMER DILINOLEYL DIMER DILINOLEATE DIGLYCERYL SEBACATE/ISOPALMITATE TRIDECYL TRIMELLITATE GOAT MILK POLYGLYCERYL-3 PENTARICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) TOCOPHEROL CORN OIL SYNTHETIC WAX (540 MW) ZINC OXIDE ZINC OXIDE HYDROGENATED POLYDECENE (1500 CST) CERESIN QUERCETIN LECITHIN, SUNFLOWER IRON OXIDES BIS-DIGLYCERYL POLYACYLADIPATE-2 PENTAERYTHRITYL TETRAISOSTEARATE DIISOSTEARYL MALATE BUTYLOCTYL SALICYLATE CAPRYLIC/CAPRIC TRIGLYCERIDE ETHYLHEXYL PALMITATE SILICA BEHENYL ACRYLATE POLYMER ISOSTEARIC ACID POLYGLYCERYL-2 TRIISOSTEARATE TITANIUM DIOXIDE"
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 9.82%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "USES 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 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"
      ],
      "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 Directions Apply liberally 15 minutes before sun exposure Reapply: use a water resistant sunscreen if swimming or sweating at least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m.- 2p.m. Wear long-sleeved shirts, pants, hats and sunglasses"
      ],
      "inactive_ingredient": [
        "Inactive ingredients: Hydrogenated Polydecene, Diisostearyl Malate, Ozokerite, Synthetic Wax, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Butyloctyl Salicylate, Tridecyl Trimellitate, Bis-Diglyceryl Polyacyladipate-2, Pentaerylhrityl Tetraisostearate, Polyglyceryl-4 Isostearate, Dimer Dilinoleyl Dimer Dilinoleate, Diglyceryl Sebacate/lsopalmitate*, Moringa Oil/Hydrogenated Moringa Oil Esters, Polyhydroxystearic Acid, Silica, Caprae Lac (Goat Milk), Tocopherol (Vitamin E), Kaolin, Hydrogenated Vegetable Oil, Quercetin, Oleic/Linoleic/Linolenic Polyglycerides, Poly C10-30 Alkyl Acrylate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-2 Triisostearate, Stearalkonium Hectorite, Propylene Carbonate, Dehydroacetic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Iron Oxides (CI 77492), Titanium Dioxide (CI 77891), Carmine (CI 75470)."
      ],
      "package_label_principal_display_panel": [
        "Primary Package"
      ],
      "set_id": "29227121-e579-8eea-e063-6394a90a302f",
      "id": "29227121-e57a-8eea-e063-6394a90a302f",
      "effective_time": "20241213",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Tinted Lip Cream SPF 15"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "COSMAX USA, CORPORATION"
        ],
        "product_ndc": [
          "68577-168"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "29227121-e57a-8eea-e063-6394a90a302f"
        ],
        "spl_set_id": [
          "29227121-e579-8eea-e063-6394a90a302f"
        ],
        "package_ndc": [
          "68577-168-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}