{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "BABYGANICS SPF 50 Plus SUNSCREEN ZINC OXIDE, OCTISALATE, and OCTOCRYLENE ZINC OXIDE ZINC OXIDE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN BUTYLOCTYL SALICYLATE GLYCERYL MONOSTEARATE POLYSORBATE 80 PHENYLETHYL ALCOHOL GLYCERYL MONOCAPRYLATE LAPONITE XANTHAN GUM HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) CITRIC ACID MONOHYDRATE SQUALANE TOMATO SEED OIL SUNFLOWER OIL SOYBEAN LECITHIN POLYSORBATE 60 ALOE VERA LEAF CRANBERRY SEED OIL RASPBERRY SEED OIL NIGELLA SATIVA SEED OIL SORBITAN ISOSTEARATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "dist. by KAS Direct, LLC. Westbury, NY 11590"
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide 11.20%, Octocrylene 6.0%, Octisalate 5.0%"
      ],
      "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": [
        "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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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 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 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours do not spray directly into face. Spray on hands then apply to face. children under 6 months of age: 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"
      ],
      "storage_and_handling": [
        "Other information protect this product from excessive heat and direct sun"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, caprylic/capric triglyceride, glycerin, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label 50 + SPF tear free water resistant babyganics SPF 50+ sunscreen spray broad spectrum SPF 50+ UVA + UVB protection water resistant (80 minutes) non-allergenic • pediatrician & dermatologist tested formulated with: Zinc Oxide, Octocrylene, Octisalate* formulated without: PABA phthalates • parabens fragrances • nano-particles Discover which of our ingredients are Certified Organic on back panel. 6 FL OZ (177 mL) 040-12078-B02 PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label"
      ],
      "set_id": "4075f9dc-c25f-434f-a3fc-a7f896295c3d",
      "id": "0bd9880a-6b33-495b-a58e-7a5e65cbac4a",
      "effective_time": "20241220",
      "version": "4",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "BABYGANICS SPF 50 Plus SUNSCREEN"
        ],
        "generic_name": [
          "ZINC OXIDE, OCTISALATE, AND OCTOCRYLENE"
        ],
        "manufacturer_name": [
          "KAS Direct LLC dba Babyganics"
        ],
        "product_ndc": [
          "59062-0120"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "OCTISALATE",
          "OCTOCRYLENE"
        ],
        "spl_id": [
          "0bd9880a-6b33-495b-a58e-7a5e65cbac4a"
        ],
        "spl_set_id": [
          "4075f9dc-c25f-434f-a3fc-a7f896295c3d"
        ],
        "package_ndc": [
          "59062-0120-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0813277012078"
        ],
        "unii": [
          "SOI2LOH54Z",
          "4X49Y0596W",
          "5A68WGF6WM"
        ]
      }
    }
  ]
}