{
  "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": [
        "Broad Spectrum SPF45 Zinc Oxide, Octinoxate ZINC OXIDE ZINC CATION OCTINOXATE OCTINOXATE WATER CYCLOMETHICONE 5 NIACINAMIDE OLETH-3 PHOSPHATE OCTYLDODECYL NEOPENTANOATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) POLYISOBUTYLENE (1000 MW) PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER GLYCERIN .ALPHA.-TOCOPHEROL ACETATE POLYGONUM AVICULARE TOP HYALURONATE SODIUM EDETATE DISODIUM SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE PHENOXYETHANOL ETHYLHEXYLGLYCERIN POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE TRIETHOXYCAPRYLYLSILANE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "MEDICAL GRADE SKIN CARE PROTECT defend//prevent Broad Spectrum UVA/UVB Protection Dist. by DRMTLGY, LLC Chatsworth, CA 91311 www.DRMTLGY.com Made in USA"
      ],
      "active_ingredient": [
        "Active ingredients Zinc Oxide 12% Octinoxate 7.5%"
      ],
      "purpose": [
        "Purpose Sunscreen"
      ],
      "indications_and_usage": [
        "Uses Helps prevent sunburn. • If used as directed with other sun protection measures, 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 and ask physician if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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 to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours."
      ],
      "precautions": [
        "Precautions • 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 value of SPF 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. Children under 6 months of age: Ask a physician."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Water, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Glycerin, Tocopheryl Acetate, Polygonum Aviculare Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane"
      ],
      "questions": [
        "Questions or comments? 1-888-DRMTLGY"
      ],
      "package_label_principal_display_panel": [
        "Packaging Broad Spectrum SPF45"
      ],
      "set_id": "ce93b371-26ab-4493-98e0-98234c3a9ba6",
      "id": "f6752fc2-97f8-4812-bd32-c91fb9b703be",
      "effective_time": "20250501",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Broad Spectrum SPF45"
        ],
        "generic_name": [
          "ZINC OXIDE, OCTINOXATE"
        ],
        "manufacturer_name": [
          "Drmtlgy, LLC"
        ],
        "product_ndc": [
          "83286-008"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "OCTINOXATE"
        ],
        "spl_id": [
          "f6752fc2-97f8-4812-bd32-c91fb9b703be"
        ],
        "spl_set_id": [
          "ce93b371-26ab-4493-98e0-98234c3a9ba6"
        ],
        "package_ndc": [
          "83286-008-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z",
          "4Y5P7MUD51"
        ]
      }
    }
  ]
}