{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Calming Primer SPF 20 Titanium Dioxide and Zinc Oxide Titanium Dioxide Titanium Dioxide Zinc Oxide Zinc Oxide Cyclomethicone 5 Dimethicone Crosspolymer (450000 MPA.S AT 12% IN Cyclopentasiloxane) MEDIUM-CHAIN TRIGLYCERIDES Water Glycerin Dimethicone Disodium Lauriminodipropionate Tocopheryl Phosphates Dimethiconol (100000 CST) ARTHROSPIRA MAXIMA FERRIC OXIDE YELLOW Citrus Paradisi Seed Phenoxyethanol Triethoxycaprylylsilane Ascorbic Acid Green Tea Leaf PALMARIA PALMATA FERRIC OXIDE RED Opuntia Ficus-Indica Stem FERROSOFERRIC OXIDE Benzoic Acid Dehydroacetic Acid"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Titanium Dioxide 5.4% Sunscreen Zinc Oxide 5.4% Sunscreen"
      ],
      "active_ingredient_table": [
        "<table width=\"50%\"><col width=\"60%\" align=\"left\" valign=\"bottom\"/><col width=\"40%\" align=\"right\" valign=\"bottom\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Titanium Dioxide 5.4%</td><td>Sunscreen</td></tr><tr><td>Zinc Oxide 5.4%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purpose Titanium Dioxide 5.4% Sunscreen Zinc Oxide 5.4% Sunscreen"
      ],
      "purpose_table": [
        "<table width=\"50%\"><col width=\"60%\" align=\"left\" valign=\"bottom\"/><col width=\"40%\" align=\"right\" valign=\"bottom\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Titanium Dioxide 5.4%</td><td>Sunscreen</td></tr><tr><td>Zinc Oxide 5.4%</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. 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. Works best on moisturized skin. Reapply: After 40 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: 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."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Cyclopentasiloxane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Glycerin, Water, Dimethicone/Vinyl Dimethicone Crosspolymer, Cucumis Sativus (Cucumber) Fruit Extract, Spirulina Maxima Extract, Camellia Sinensis Leaf Extract, Opuntia Ficus-Indica Stem Extract, Palmaria Palmata Extract, Disodium Lauriminodipropionate Tocopheryl Phosphates, Citrus Paradisi (Grapefruit) Seed Extract, Ascorbic Acid, Dimethiconol, Dimethicone, Triethoxycaprylylsilane, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)"
      ],
      "storage_and_handling": [
        "Other information Protect this product from excessive heat and direct sun."
      ],
      "questions": [
        "Questions or comments? Call toll free 866.426.5673"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton colorescience ® CALMING PRIMER 3-IN-1 FACE PRIMER Neutralizes redness Soothes & nourishes skin Extends makeup wear 20 Broad Spectrum SPF 20 Sunscreen CHEMICAL-FREE ACTIVES | 100% MINERAL WATER/SWEAT RESISTANT (40 MINUTES) 1 fl. oz. / 30 mL PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton"
      ],
      "set_id": "d681cdb5-307e-4a2a-8e1d-2b29131d48d0",
      "id": "54f6f676-1299-4c63-b090-fc1bc26b76eb",
      "effective_time": "20241213",
      "version": "2",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Calming Primer SPF 20"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE AND ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Colorescience"
        ],
        "product_ndc": [
          "68078-040"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TITANIUM DIOXIDE",
          "ZINC OXIDE"
        ],
        "spl_id": [
          "54f6f676-1299-4c63-b090-fc1bc26b76eb"
        ],
        "spl_set_id": [
          "d681cdb5-307e-4a2a-8e1d-2b29131d48d0"
        ],
        "package_ndc": [
          "68078-040-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "15FIX9V2JP",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}