{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "OS-01 Lip SPF BS SPF15 Zinc Oxide OLEIC ACID BISABOLOL ETHYLHEXYLGLYCERIN PROPYLENE HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL SODIUM HYALURONATE GLYCERYL DIOLEATE ECTOIN ETHYLHEXYL PALMITATE TRIBEHENIN SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL .ALPHA.-TOCOPHEROL ACETATE DIPALMITOYL HYDROXYPROLINE POLYHYDROXYSTEARIC ACID (2300 MW) GLYCERIN TRIHYDROXYSTEARIN WATER GARCINIA INDICA SEED BUTTER GLYCERYL OLEATE SQUALENE LACTIC ACID GLUCOMANNAN POLYGLYCERYL-3 PENTARICINOLEATE ETHYLENE BUTYLOCTYL SALICYLATE HIPPOPHAE RHAMNOIDES SEED OIL ISOSTEARIC ACID LECITHIN, SUNFLOWER TETRAHEXYLDECYL ASCORBATE SORBITAN ISOSTEARATE CAPRYLIC/CAPRIC TRIGLYCERIDE 1-BUTENE PALMITOYL TRIPEPTIDE-1 CAPRYLYL/CAPRYL GLUCOSIDE PROPANEDIOL CENTELLA ASIATICA TRITERPENOIDS CARNAUBA WAX TOCOPHEROL PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE BETA-SITOSTEROL PALMITIC ACID ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active ingredie: Zinc Oxide 5.5%."
      ],
      "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 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 swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions: • Apply liberally 15 minutes before sun exposure. • Reapply at least every 2 hours • Use a water-resistant sunscreen If swimming or sweating. • Children under 8 months of age: Ask a Doctor. • Sun Probation 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"
      ],
      "other_safety_information": [
        "Other information Protect the product in this container from excessive heat and direct sun."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Simmondsia Chinensis (Jojoba) Seed Oil, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Palmitate, Butyl octyl Salicylate. Caprylic/Capric Triglyceride, Water (Aqua), Garcinia Indica Seed Butter, Tocopheryl Acetate, Butylene/Ethylene/Styrene Copolymer, Glyceryl Oleate, Glyceryl Dioleate, Glycerin, Oleic Acid, Tribehenin, Sorbitan Isostearate, Palmitoyl Tripeptide-1, Dipalmitoyl Hydroxyproline, Trihydroxystearin, Sodium Hyaluronate, Glucomannan, Tetrahexyldecyl Ascorbate, Bisabolol, Decapeptide-52*,Ethylhexylglycerin, Caprylyl/Capryl Glucoside, Propanediol, Ectoin, Centella Asiatica Extract, Hippophae Rhamnoides oil, Helianthus Annuus (Sunflower) Seed Oil, Copernicia Cerifera (Carnauba)Wax, Tocopherol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxy stearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Beta-Sitosterol, Squalene, Lactic Acid, Palmitic acid."
      ],
      "package_label_principal_display_panel": [
        "OS-01 lip spf"
      ],
      "set_id": "351d55f6-fcd9-1d47-e063-6294a90a2cf0",
      "id": "351d69f9-5ae2-1dec-e063-6294a90ad7a1",
      "effective_time": "20250514",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "OS-01 Lip SPF BS SPF15"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "ONESKIN INC."
        ],
        "product_ndc": [
          "84451-004"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "351d69f9-5ae2-1dec-e063-6294a90ad7a1"
        ],
        "spl_set_id": [
          "351d55f6-fcd9-1d47-e063-6294a90a2cf0"
        ],
        "package_ndc": [
          "84451-004-01",
          "84451-004-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}