{
  "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": [
        "BabyGanics Sunscreen 30 SPF ZINC OXIDE, OCTINOXATE, and OCTISALATE ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN HEXADECYL POVIDONE ALOE VERA LEAF GLYCERYL MONOSTEARATE POLYGLYCERYL-6 DIOLEATE POLYSORBATE 80 PHENYLETHYL ALCOHOL GLYCERYL MONOCAPRYLATE SODIUM MAGNESIUM FLUOROSILICATE XANTHAN GUM HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) SQUALANE CITRIC ACID MONOHYDRATE SOYBEAN LECITHIN POLYSORBATE 60 SORBITAN ISOSTEARATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: KAS Direct, LLC. Hicksville, NY 11801"
      ],
      "active_ingredient": [
        "Active ingredients Octinoxate 5.0%, Octisalate 4.0%, Zinc oxide 11.2%"
      ],
      "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 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, vp/hexadecene copolymer, aloe barbadensis leaf juice, glyceryl stearate, hexaglyceryl polyricinoleate, polysorbate 80, phenethyl alcohol, glyceryl caprylate, sodium magnesium silicate, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, squalane, citric acid, lecithin, polysorbate 60, sorbitan isostearate."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label 30 SPF tear free water resistant babyganics ® mineral-based sunscreen spray broad spectrum SPF 30 UVA + UVB protection water resistant (80 minutes) non-allergenic no: PABA, phthalates, parabens, fragrances or nano-particles 6 FL OZ (177mL) 040-12290-01 Principal Display Panel - 177 mL Bottle Label"
      ],
      "set_id": "391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1",
      "id": "288cb5ff-0e3f-40de-8e46-3424f6d03c2c",
      "effective_time": "20241219",
      "version": "5",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "BabyGanics Sunscreen 30 SPF"
        ],
        "generic_name": [
          "ZINC OXIDE, OCTINOXATE, AND OCTISALATE"
        ],
        "manufacturer_name": [
          "KAS Direct LLC dba BabyGanics"
        ],
        "product_ndc": [
          "59062-1229"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "OCTINOXATE",
          "OCTISALATE"
        ],
        "spl_id": [
          "288cb5ff-0e3f-40de-8e46-3424f6d03c2c"
        ],
        "spl_set_id": [
          "391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1"
        ],
        "package_ndc": [
          "59062-1229-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0813277012290"
        ],
        "unii": [
          "SOI2LOH54Z",
          "4Y5P7MUD51",
          "4X49Y0596W"
        ]
      }
    }
  ]
}