{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Leg and Body Makeup Broad Spectrum SPF 25 Octisalate 3.2% Octocrylene 6% DISTEARDIMONIUM HECTORITE BUTYLPARABEN HYALURONATE SODIUM OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER CYCLOMETHICONE 5 ISONONYL ISONONANOATE POLYGLYCERYL-4 ISOSTEARATE METHYLPARABEN CHLORPHENESIN DIPROPYLENE GLYCOL FERRIC OXIDE RED ISODODECANE GLYCERIN CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) DIMETHICONE ALCOHOL TOCOPHEROL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) TITANIUM DIOXIDE DISODIUM STEAROYL GLUTAMATE PHENOXYETHANOL POLYBUTENE (1400 MW) ISOBUTANE ALUMINUM HYDROXIDE SODIUM CITRATE"
      ],
      "active_ingredient": [
        "Active ingredients Octisalate 3.2% Octocrylene 6%"
      ],
      "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": [
        "For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if rash occurs"
      ],
      "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."
      ],
      "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."
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs"
      ],
      "dosage_and_administration": [
        "Directions For sunscreen use: ● apply liberally 15 minutes before sun exposure ● 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 ● children under 6 months of age: Ask a doctor"
      ],
      "other_safety_information": [
        "Other information protect the product in this container from excessive heat and direct sun"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG 10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides"
      ],
      "questions": [
        "1-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)"
      ],
      "package_label_principal_display_panel": [
        "Leg and Body Makeup"
      ],
      "set_id": "14adc826-6e9d-382a-e063-6294a90a5d79",
      "id": "3aaeeafe-b737-c1e4-e063-6394a90af100",
      "effective_time": "20250724",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Leg and Body Makeup Broad Spectrum SPF 25"
        ],
        "generic_name": [
          "OCTISALATE 3.2% OCTOCRYLENE 6%"
        ],
        "manufacturer_name": [
          "Baxter of California, LLC"
        ],
        "product_ndc": [
          "84203-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OCTISALATE",
          "OCTOCRYLENE"
        ],
        "spl_id": [
          "3aaeeafe-b737-c1e4-e063-6394a90af100"
        ],
        "spl_set_id": [
          "14adc826-6e9d-382a-e063-6294a90a5d79"
        ],
        "package_ndc": [
          "84203-002-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4X49Y0596W",
          "5A68WGF6WM"
        ]
      }
    }
  ]
}