{
  "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": [
        "Replenix Sheer SPF 50 Zinc Oxide Titanium Dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ACRYLATES CROSSPOLYMER-4 ASCORBIC ACID BIOTIN BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL CETETH-10 PHOSPHATE CYCLOMETHICONE DIHEXADECYL PHOSPHATE DIMETHICONE EDETATE DISODIUM HEXYL LAURATE ISODODECANE LAURYL PEG/PPG-18/18 METHICONE LECITHIN, SUNFLOWER PEG-10 DIMETHICONE (200 CST) PHENOXYETHANOL PHYLLANTHUS EMBLICA FRUIT POLYHYDROXYSTEARIC ACID (2300 MW) POLYMETHYLSILSESQUIOXANE (11 MICRONS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) POTASSIUM CETYL PHOSPHATE POTASSIUM HYDROXIDE WATER RESVERATROL STEARIC ACID UBIDECARENONE VITAMIN A PALMITATE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Purpose Zinc Oxide 16.5% Sunscreen Titanium Dioxide 2.3% Sunscreen"
      ],
      "active_ingredient_table": [
        "<table width=\"50%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredient</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Zinc Oxide 16.5%</td><td>Sunscreen</td></tr><tr><td>Titanium Dioxide 2.3%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredient Purpose Zinc Oxide 16.5% Sunscreen Titanium Dioxide 2.3% Sunscreen"
      ],
      "purpose_table": [
        "<table width=\"50%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredient</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Zinc Oxide 16.5%</td><td>Sunscreen</td></tr><tr><td>Titanium Dioxide 2.3%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "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 10a.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."
      ],
      "dosage_and_administration": [
        "Directions Apply liberally and spread evenly by hand 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 Acrylates Crosspolymer-4, Ascorbic Acid, Biotin, Butyrospermum Parkii Butter, Camellia Sinensis Leaf (Green Tea) Polyphenols, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclomethicone, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Hexyl Laurate, Isododecane, Lauryl PEG/PPG-18/18 Methicone, Lecithin, PEG-10 Dimethicone, Phenoxyethanol, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polysilicone-11, Potassium Cetyl Phosphate, Potassium Hydroxide, Purified Water, Resveratrol, Stearic Acid, Ubiquinone (Coenzyme Q-10), Retinyl Palimtate, Xanthan Gum."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 60 g Bottle Label REPLENiX ® SHEER PHYSICAL SUNSCREEN SPF 50+ CREAM UVA UVB BROAD SPECTRUM SPF 50+ Zinc Oxide 13.75% Green Tea Polyphenols Resveratrol Vitamin C Emblica CoQ10 Net 2 fl. oz. (60 ml) Topix Pharmaceuticals, Inc. N. Amityville, NY 11701 PRINCIPAL DISPLAY PANEL - 60 g Bottle Label"
      ],
      "set_id": "37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4",
      "id": "1abf4f5e-ecc6-41c4-9bfb-617ad5a786fd",
      "effective_time": "20240729",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Replenix Sheer SPF 50"
        ],
        "generic_name": [
          "ZINC OXIDE TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "Topiderm, Inc."
        ],
        "product_ndc": [
          "51326-858"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "1abf4f5e-ecc6-41c4-9bfb-617ad5a786fd"
        ],
        "spl_set_id": [
          "37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4"
        ],
        "package_ndc": [
          "51326-858-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "15FIX9V2JP"
        ]
      }
    }
  ]
}