{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Bluevado Sunfix Zinc Oxide, Titanium Dioxide ARGAN OIL ASCORBYL PALMITATE LEVOMENOL SHEA BUTTER C13-15 ALKANE MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL CETYL ALCOHOL BERGAMOT OIL CITRUS MAXIMA FRUIT RIND OIL COCONUT OIL GLYCERIN GLYCERYL MONOSTEARATE HEPTYL UNDECYLENATE LAVENDER OIL METHYLENE BLUE RICE BRAN OIL PEG-100 STEARATE GERANIUM OIL, ALGERIAN TYPE PHENOXYETHANOL POLYSORBATE 60 SORBITAN MONOLAURATE .ALPHA.-TOCOPHEROL ACETATE WATER XANTHAN GUM ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE"
      ],
      "active_ingredient": [
        "Active Ingredients Zinc Oxide 8.2% Titanium Dioxide 2.8%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn If used with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging."
      ],
      "warnings": [
        "Warnings: For external use only Do not use on damaged or broken skin. When using thus product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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: Apply liberally 15 minutes before sun exposure Reapply: after 40 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 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 sleeves shirts, pants, hats, and sunglasses Children under 6 months: Ask a physician."
      ],
      "other_safety_information": [
        "Other Information: Protect this product from excessive heat and direct sun. Provides moderate protection against sunburn."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Argania Spinosa (Argan) Kernel Oil, Ascorbyl Palmitate, Bisabolol Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil, Glycerin, Glyceryl Stearate, Heptyl Undecylenate, Jojoba Esters, Lavandula Angustifolia (Lavender) Oil, Methylene Blue, Oryza Sativa (Rice) Bran Oil, PEG-100 Stearate, Pelargonium Graveolens (Geranium) Leaf Oil, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 60, Sorbitan Laurate, Tocopheryl Acetate, Water (Aqua), Xanthan Gum."
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel Bluelene® Bluevado™ SunFix Protects, Repairs & Moisturizes SPF 21 SPF DAY CREAM Revolutionary Anti-aging Technology Mineral + Methylene Blue Broad-Spectrum UVA/UVB Coverage CORAL SAFE 3 fl oz (90 mL) Manufactured for Mblue Labs, Bethesda, MD 20817, USA 1-800-988-8068 www.bluelene.com Label image-01"
      ],
      "set_id": "2e5315bf-39f4-401c-8207-18ef6a97e024",
      "id": "484a56e3-3673-c351-e063-6294a90aa340",
      "effective_time": "20260113",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Bluevado Sunfix"
        ],
        "generic_name": [
          "ZINC OXIDE, TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "Magic Blue, LLC"
        ],
        "product_ndc": [
          "77358-201"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "484a56e3-3673-c351-e063-6294a90aa340"
        ],
        "spl_set_id": [
          "2e5315bf-39f4-401c-8207-18ef6a97e024"
        ],
        "package_ndc": [
          "77358-201-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "15FIX9V2JP"
        ]
      }
    }
  ]
}