{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Blue Lizard Baby SPF 50 Sunscreen Titanium Dioxide and Zinc Oxide ALUMINUM OXIDE ALUMINUM STEARATE TRIETHOXYCAPRYLYLSILANE YELLOW WAX CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) ALKYL (C12-15) BENZOATE EDETATE DISODIUM ETHYLHEXYL PALMITATE ETHYLHEXYL STEARATE CAPRYLYL GLYCOL HEXYL LAURATE HYDROGENATED CASTOR OIL METHYL GLUCOSE DIOLEATE CHLORPHENESIN OCTYLDODECYL NEOPENTANOATE PEG-7 HYDROGENATED CASTOR OIL POLYGLYCERYL-4 ISOSTEARATE PHENOXYETHANOL PROPANEDIOL WATER SORBITAN MONOOLEATE STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE DIMETHICONE TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE POLYHYDROXYSTEARIC ACID (2300 MW) CETYL DIMETHICONE 25"
      ],
      "active_ingredient": [
        "Active Ingredients Titanium Dioxide 8% Zinc Oxide 10%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn and photodamage caused by UVA/UVB exposure Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see Directions ), decreases the risks of skin cancer and early skin aging caused by the sun"
      ],
      "warnings": [
        "Warnings • When using this product • Keep out of eyes. Rinse with water to remove • Stop use and ask doctor if • Rash or irritation occurs • Do not use • On damaged or broken skin • If allergic to any ingredient • If swallowed, get medical help or contact a Poison Control Center"
      ],
      "dosage_and_administration": [
        "Directions • Shake well prior to use • Apply liberally to dry skin 15 minutes before sun exposure • For topical use only • 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 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. • Reapply to dry skin : • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours Keep out of reach of children"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "other_safety_information": [
        "Other Information Protect the product in this container from excessive heat and direct sun May stain some fabrics"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Alumina, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer"
      ],
      "questions": [
        "Questions? Visit www.bluelizardsunscreen.com or call 800.877.8869 Crown Laboratories, Inc., Johnson City, TN 37604"
      ],
      "package_label_principal_display_panel": [
        "Blue Lizard Baby 3oz Tube BLUE LIZARD AUSTRALIAN SUNSCREEN 50+ UVA/UVB PROTECTION BROAD SPECTRUM SPF 50+ No. 1 PEDIATRICIAN RECOMMENDED mineral-based sunscreen brand BABY mineral sunscreen Smart Cap TECHNOLOGY CAP CHANGES COLOR IN HARMFUL UV LIGHT WATER RESISTANT (80 MINUTES) 3fl oz (89ml) Mineral Sunscreen Protects your skin by acting like thousands of tiny shields that reflect UV rays. P11642.01 p116472"
      ],
      "set_id": "9d237fb7-4f5f-521d-e053-2a95a90a9734",
      "id": "4833f8fa-f0bc-dd53-e063-6294a90a3899",
      "effective_time": "20260112",
      "version": "7",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Blue Lizard Baby SPF 50 Sunscreen"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE AND ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Crown Laboratories"
        ],
        "product_ndc": [
          "0316-2036"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "4833f8fa-f0bc-dd53-e063-6294a90a3899"
        ],
        "spl_set_id": [
          "9d237fb7-4f5f-521d-e053-2a95a90a9734"
        ],
        "package_ndc": [
          "0316-2036-30",
          "0316-2036-40",
          "0316-2036-50",
          "0316-2036-10",
          "0316-2036-45",
          "0316-2036-46"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303162036307"
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}