{
  "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 Tinted Sunscreen SPF 50 Zinc Oxide and Octinoxate ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE WATER NIACINAMIDE OLETH-3 PHOSPHATE NEOPENTYL GLYCOL DIHEPTANOATE HYDROGENATED POLYBUTENE (1300 MW) OCTYLDODECYL NEOPENTANOATE BUTYLENE GLYCOL HYALURONATE SODIUM .ALPHA.-TOCOPHEROL ACETATE CAFFEINE DIMETHICONE PANTHENOL SUCROSE HYDROLYZED JOJOBA ESTERS (ACID FORM) LACTIC ACID, DL- GLYCERIN ETHYLHEXYL STEARATE TRIETHOXYCAPRYLYLSILANE XANTHAN GUM LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE FERROUS OXIDE 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 ingredient Purpose Zinc Oxide 14.5% Sunscreen Octinoxate 7.5% Sunscreen"
      ],
      "active_ingredient_table": [
        "<table width=\"55%\"><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 14.5%</td><td>Sunscreen</td></tr><tr><td>Octinoxate 7.5%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredient Purpose Zinc Oxide 14.5% Sunscreen Octinoxate 7.5% Sunscreen"
      ],
      "purpose_table": [
        "<table width=\"55%\"><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 14.5%</td><td>Sunscreen</td></tr><tr><td>Octinoxate 7.5%</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 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."
      ],
      "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, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Dimethicone, Panthenol, Sucrose, Jojoba Esters, Lactic Acid, Glycerin, Ethylhexyl Stearate, Triethoxycaprylylsilane, Xanthan Gum, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxides, 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 REPLENiX ® SUNSCREEN ESSENTIAL OIL FREE TINTED SPF 50 14.5% Micronized Zinc Oxide Multi-tasking tinted application Sensitive skin friendly BROAD SPECTRUM UVA/UVB SPF 50 Net wt. 2.22 oz. (63 g) TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701 PRINCIPAL DISPLAY PANEL - 63 g Bottle Label"
      ],
      "set_id": "1fda4a54-e323-4f3c-b659-bded4b1b3dd0",
      "id": "d4677ccd-57aa-437f-b862-58bb18b80028",
      "effective_time": "20230222",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Replenix Tinted Sunscreen SPF 50"
        ],
        "generic_name": [
          "ZINC OXIDE AND OCTINOXATE"
        ],
        "manufacturer_name": [
          "Topiderm, Inc."
        ],
        "product_ndc": [
          "51326-201"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "OCTINOXATE"
        ],
        "spl_id": [
          "d4677ccd-57aa-437f-b862-58bb18b80028"
        ],
        "spl_set_id": [
          "1fda4a54-e323-4f3c-b659-bded4b1b3dd0"
        ],
        "package_ndc": [
          "51326-201-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "4Y5P7MUD51"
        ]
      }
    }
  ]
}