{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN zinc oxide, titanium dioxide ALUMINUM OXIDE ETHYLENE BRASSYLATE SOLANUM LYCOPERSICUM FRUITING TOP ALPHA-TOCOPHEROL ACETATE RICE BRAN FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE APRICOT KERNEL OIL LUPINUS ALBUS SEED OIL TRIETHOXYCAPRYLYLSILANE ZINC OXIDE ZINC OXIDE DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) WHEAT GERM OIL UNSAPONIFIABLES TITANIUM DIOXIDE TITANIUM DIOXIDE TRIHYDROXYSTEARIN HEXYL LAURATE CARNAUBA WAX PEG-10 DIMETHICONE (220 CST) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) STEARIC ACID ISONONYL ISONONANOATE POLYGLYCERYL-4 ISOSTEARATE TOCOPHEROL"
      ],
      "spl_unclassified_section": [
        "Product Facts / Drug Facts Active ingredient: Titanium Dioxide 11.2% Zinc Oxide 8.4% Purpose Sunscreen",
        "www.gmcollin.com DISTRIBUÉ PAR / DISTRIBUTED BY: ® LAB. DERMO-COSMETIK INC. 68 STINSON, MONTREAL, QUEBEC, CANADA H4N 2E7 FABRIQUÉ AU CANADA / MADE IN CANADA"
      ],
      "active_ingredient": [
        "Active ingredient: Titanium Dioxide 11.2% Zinc Oxide 8.4%"
      ],
      "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. 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 Adults over 18 years old: • apply liberally 15 minutes before sun exposure. • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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."
      ],
      "storage_and_handling": [
        "Other information • protect this product from excessive heat and direct sun. • keep at room temperature (15 - 30˚C / 59 - 86˚F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients DIMETHICONE, PEG-10 DIMETHICONE, HEXYL LAURATE, COPERNICIA CERIFERA (CARNAUBA) WAX / CIRE DE CARNAUBA, POLYSILICONE-11, ISONONYL ISONONANOATE, TRIHYDROXYSTEARIN, POLYGLYCERYL-4 ISOSTEARATE, POLYMETHYLSILSESQUIOXANE, STEARIC ACID / ACIDE STÉARIQUE, IRON OXIDES / OXYDES DE FER, PRUNUS ARMENIACA (APRICOT) KERNEL OIL / HUILE DE NOYAU D’ABRICOT, TOCOPHERYL ACETATE, LUPINUS ALBUS SEED OIL / HUILE DE GRAINES DE LUPIN, TRITICUM VULGARE (WHEAT) GERM OIL UNSAPONIFIABLES / HUILES INSAPONIFIABLES DE GERME BLÉ, SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT / EXTRAIT DE FRUIT/FEUILLE/TIGE DE TOMATE, TOCOPHEROL, ALUMINA, ETHYLENE BRASSYLATE, ORYZA SATIVA (RICE) BRAN WAX / CIRE DE SON DE RIZ, TRIETHOXYCAPRYLYLSILANE."
      ],
      "questions": [
        "Questions? USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263"
      ],
      "package_label_principal_display_panel": [
        "PP label"
      ],
      "set_id": "01dcfd14-7a1d-98fa-e063-6294a90a0336",
      "id": "458b7274-da08-6bf7-e063-6394a90a4881",
      "effective_time": "20251209",
      "version": "3",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN"
        ],
        "generic_name": [
          "ZINC OXIDE, TITANIUM DIOXIDE"
        ],
        "manufacturer_name": [
          "LABORATOIRES DERMO-COSMETIK INC."
        ],
        "product_ndc": [
          "64127-244"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE",
          "TITANIUM DIOXIDE"
        ],
        "spl_id": [
          "458b7274-da08-6bf7-e063-6394a90a4881"
        ],
        "spl_set_id": [
          "01dcfd14-7a1d-98fa-e063-6294a90a0336"
        ],
        "package_ndc": [
          "64127-244-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0845144017466"
        ],
        "unii": [
          "SOI2LOH54Z",
          "15FIX9V2JP"
        ]
      }
    }
  ]
}