{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Essential Sheer SPF 50 zinc oxide titanium dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER NIACINAMIDE OLETH-3 PHOSPHATE NEOPENTYL GLYCOL DIHEPTANOATE HYDROGENATED POLYISOBUTENE (1300 MW) OCTYLDODECYL NEOPENTANOATE BUTYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE HYALURONATE SODIUM CAFFEINE PANTHENOL DIMETHICONE SUCROSE LACTIC ACID, UNSPECIFIED FORM GLYCERIN ETHYLHEXYL STEARATE TRIETHOXYCAPRYLYLSILANE XANTHAN GUM PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER PHENOXYETHANOL EDETATE DISODIUM HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide 14.5% Octinoxate 7.5%"
      ],
      "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. When using this product keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. 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 sunscreen measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses"
      ],
      "when_using": [
        "When using this product keep out of eyes, rinse with water to remove."
      ],
      "stop_use": [
        "Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. 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 sunscreen measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses"
      ],
      "dosage_and_administration": [
        "Directions Apply liberally to face and neck and spread evenly 15 minutes before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Purified Water, Niacinamide, Oleth-3 Phosphate, Neopentyl Glycol Diheptanoate, Polyisobutene, Octyldodecyl, Neopentanoate, Butylene Glycol, Tocopheryl Acetate, Sodium Hyaluronate, Caffeine, Panthenol, Dimethicone, Sucrose, Lactic Acid, Glycerin, Ethylhexyl Stearate, Triethoxycaprylylsilan, Xanthan Gum, Lauryl PEG Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Phenoxyethanol, Disodium EDTA."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 63 g Bottle Label COMPLIMENTS OF TOPIX PHARMACEUTICALS, INC DAILY Sheer Lightweight Brightening Sunscreen SPF 50 Broad Spectrum SPF 50 Sunscreen FOR PATIENTS WITH ACNE, ROSACEA PRONE AND HYPERPIGMENTED SKIN Net wt. 2.22 oz. (63 g) Available Custom Branded 800.445.2595 c.service@topixpharm.com PRINCIPAL DISPLAY PANEL - 63 g Bottle Label"
      ],
      "set_id": "2132dc18-85ee-4449-86d2-d9f698f286c6",
      "id": "e627f035-e882-4c96-851e-c37debdf6910",
      "effective_time": "20240731",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Essential Sheer SPF 50"
        ],
        "generic_name": [
          "ZINC OXIDE TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "Topiderm, Inc."
        ],
        "product_ndc": [
          "51326-200"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "e627f035-e882-4c96-851e-c37debdf6910"
        ],
        "spl_set_id": [
          "2132dc18-85ee-4449-86d2-d9f698f286c6"
        ],
        "package_ndc": [
          "51326-200-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "15FIX9V2JP"
        ]
      }
    }
  ]
}