{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Coppertone Pure and Simple Sunscreen SPF 50 Zinc Oxide 24.08% ALKYL (C12-15) BENZOATE ISOPROPYL PALMITATE BUTYLOCTYL SALICYLATE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) WATER ETHYLHEXYL ISONONANOATE TEA LEAF DIMETHICONE POLYESTER-7 CYCLOMETHICONE 5 BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER ETHYLHEXYL METHOXYCRYLENE MACROCYSTIS PYRIFERA NELUMBO NUCIFERA LEAF SYNTHETIC BEESWAX HYDROXYACETOPHENONE PEG-12 DIMETHICONE CAPRYLYL GLYCOL 1,2-HEXANEDIOL PROPYLENE GLYCOL SODIUM CHLORIDE TRIETHOXYCAPRYLYLSILANE ZINC OXIDE ZINC OXIDE white to off-white"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information ■ protect this product from excessive heat and direct sun ■ may stain or damage some fabrics or surfaces"
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide 24.08%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Use ■ helps prevent sunburn"
      ],
      "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 product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions ■ shake well before each use ■ apply liberally 15 minutes before sun exposure ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ 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-sleeve shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl pelargonate, ethylhexyl methoxycrylene, polyester-27, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, 1,2-hexanediol, caprylyl glycol"
      ],
      "questions": [
        "Questions? 1-866-288-3330"
      ],
      "package_label_principal_display_panel": [
        "Coppertone ® Sunscreen Lotion Pure & Simple 100% Mineral Sun Protection † 50 Free Of oxybenzone, octinoxate, PABA, parabens, dyes, fragrance Hypoallergenic Naturally sourced zinc oxide With nourishing botanicals* Water Resistant (80 Minutes) Broad Spectrum SPF 50 PS baby PS PS kids"
      ],
      "set_id": "d8d80a15-8282-a18e-e053-2a95a90a2c6c",
      "id": "4746e3ec-5fb5-d700-e063-6394a90a7e30",
      "effective_time": "20251231",
      "version": "8",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Coppertone Pure and Simple Sunscreen SPF 50"
        ],
        "generic_name": [
          "ZINC OXIDE 24.08%"
        ],
        "manufacturer_name": [
          "Beiersdorf Inc"
        ],
        "product_ndc": [
          "66800-3993"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "4746e3ec-5fb5-d700-e063-6394a90a7e30"
        ],
        "spl_set_id": [
          "d8d80a15-8282-a18e-e053-2a95a90a2c6c"
        ],
        "package_ndc": [
          "66800-3993-2",
          "66800-3993-6",
          "66800-3993-7",
          "66800-3993-1",
          "66800-3993-5"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041100580733"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}