{
  "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,
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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "Tinted Lip Balm SPF30 Wild Peony SPF30 Lip Balm TITANIUM DIOXIDE MICA YELLOW WAX AMMONIUM GLYCYRRHIZATE HYDROGENATED CASTOR OIL BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER SHEA BUTTER THEOBROMA GRANDIFLORUM SEED BUTTER GLYCERYL STEARATE SE GLYCERYL 1-UNDECYLENATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE CASTOR OIL SUNFLOWER OIL .ALPHA.-TOCOPHEROL ACETATE POLYGLYCERYL-3 DIISOSTEARATE ARGAN OIL ALMOND OIL ISOAMYL LAURATE HELIANTHUS ANNUUS SEED WAX FERRIC OXIDE YELLOW GLYCERYL MONOBEHENATE GLYCERIN SOYBEAN OIL SESAME OIL GLYCERYL CAPRYLATE VANILLA BEAN OLIVE OIL COCONUT JOJOBA OIL WHEAT GERM OIL MEDIUM-CHAIN TRIGLYCERIDES TOCOPHEROL ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredient Zinc Oxide 19.5%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "dosage_and_administration": [
        "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. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs."
      ],
      "instructions_for_use": [
        "Directions For sunscreen use Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply 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 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."
      ],
      "keep_out_of_reach_of_children": [
        "children under 6 months: Ask a doctor"
      ],
      "other_safety_information": [
        "Other Information Protect this product from excessive heat and direct sun."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Isoamyl Laurate, Sesamum Indicum (Sesame) Seed Oil, Oleic/Linoleic/Linolenic Polyglycerides, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Fruit Oil, Ricinus Communis (Castor) Seed Oil, Glycerin, Helianthus Annuus (Sunflower) Seed Wax, Beeswax, Flavor*, Glyceryl Behenate, Glyceryl Stearate, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Dioctyldecyl Dimer Dilinoleate, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum Seed Butter, Glyceryl Caprylate, Propanediol, Tocopherol, Bisabolol, Glyceryl Undecylenate, Glycine Soja (Soybean) Oil, Ammonium Glycyrrhizate, Mica, Carmine, Titanium dioxide, Iron Oxides. * Natural Flavor"
      ],
      "questions": [
        "Questions? 1-800-849-7112 or www.burtsbees.com"
      ],
      "indications_and_usage": [
        "Helps prevent sunburn Apply as needed For external use only Do not use on damaged or broken skin"
      ],
      "package_label_principal_display_panel": [
        "image components Primary label_1"
      ],
      "set_id": "d0604720-623a-e8a9-e053-2995a90ab0e6",
      "id": "f1efbede-120a-4d12-e053-2995a90a0d82",
      "effective_time": "20230110",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Tinted Lip Balm SPF30 Wild Peony"
        ],
        "generic_name": [
          "SPF30 LIP BALM"
        ],
        "manufacturer_name": [
          "Autumn Harp"
        ],
        "product_ndc": [
          "51514-0357"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "f1efbede-120a-4d12-e053-2995a90a0d82"
        ],
        "spl_set_id": [
          "d0604720-623a-e8a9-e053-2995a90ab0e6"
        ],
        "package_ndc": [
          "51514-0357-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}