{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Alumier MD Post Procedure Kit with Hydrocortisone Titanium Dioxide, Zinc Oxide, Hydrocortisone Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen Titanium Dioxide, Zinc Oxide XYLITOL CAPRYLIC ACID ETHYLHEXYLGLYCERIN HYALURONATE SODIUM LECITHIN, SUNFLOWER POLYHYDROXYSTEARIC ACID (2300 MW) BUTYLENE GLYCOL TRICAPRYLIN GLYCERYL MONOSTEARATE NIACINAMIDE CAPRYLYL METHICONE POLYGONUM AVICULARE TOP ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE TRIETHOXYCAPRYLYLSILANE WATER ACACIA POLYOXYL 20 CETOSTEARYL ETHER MAGNESIUM ASCORBYL PHOSPHATE ASCORBIC ACID BUTYLOCTYL SALICYLATE GLYCERIN VITIS VINIFERA SEED ALUMINUM MONOSTEARATE MEDIUM-CHAIN TRIGLYCERIDES XANTHAN GUM ALKYL (C12-15) BENZOATE PROPANEDIOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL ACETATE MICROCRYSTALLINE CELLULOSE EDETATE DISODIUM EDETIC ACID CETOSTEARYL ALCOHOL PEG-100 STEARATE ALUMINUM OXIDE GLUTATHIONE PHENOXYETHANOL RESVERATROL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) TOCOPHEROL PHYSALIS ANGULATA POLY(METHYL METHACRYLATE; 450000 MW) SODIUM BENZOATE DIMETHICONE CAPRYLYL GLYCOL PENTYLENE GLYCOL POTASSIUM SORBATE Alumier MD SensiCalm Gentle Facial Cleanser CAPRYLYL GLYCOL LINALOOL, (+/-)- SORBITAN MONOOLEATE CERAMIDE NG POLYISOBUTYLENE (1000 MW) CITRIC ACID MONOHYDRATE SUCROSE STEARATE CETYL ALCOHOL NIACINAMIDE ALLANTOIN .ALPHA.-TOCOPHEROL ACETATE P-ANISIC ACID XANTHAN GUM SODIUM HYDROXIDE CAPRYLYL/CAPRYL OLIGOGLUCOSIDE XYLITOL CAPRYLIC ACID 4-TERPINEOL, (+/-)- EDETATE SODIUM EDETIC ACID EDETATE DISODIUM EDETIC ACID COCAMIDOPROPYL HYDROXYSULTAINE WATER GLYCERIN PROPANEDIOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) ALOE VERA LEAF YUCCA SCHIDIGERA ROOT SUNFLOWER OIL LINALYL ACETATE .BETA.-OCIMENE, (3Z)- SODIUM CHLORIDE DISODIUM COCOYL GLUTAMATE SODIUM COCOYL GLUTAMATE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) MEDIUM-CHAIN TRIGLYCERIDES Alumier MD Intensive Recovery Hydrocortisone LECITHIN, SUNFLOWER WATER GLYCERIN DIMETHICONE DOCOSANOL COCOA BUTTER NIACINAMIDE PREZATIDE COPPER INDIAN FRANKINCENSE HONEY EDETATE DISODIUM TRICAPRYLIN XYLITOL SODIUM METHYL STEAROYL TAURATE XANTHAN GUM ETHYLHEXYLGLYCERIN MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL SHEA BUTTER JOJOBA OIL RESVERATROL ASPALATHUS LINEARIS LEAF SQUALANE ALOE VERA LEAF POLY(METHYL METHACRYLATE; 450000 MW) SODIUM HYDROXIDE CAPRYLYL GLYCOL CAPRYLIC ACID HYDROGENATED SOYBEAN LECITHIN HYDROCORTISONE HYDROCORTISONE CERAMIDE NP CERAMIDE NG"
      ],
      "spl_unclassified_section": [
        "Product Facts"
      ],
      "active_ingredient": [
        "Active Ingredients Clear Shield: Titanium Dioxide 7% Zinc Oxide 6.18% Intensive Recovery: Hydrocortisone 1.0%"
      ],
      "purpose": [
        "Purpose Clear Shield: Sunscreen Intensive Recovery: Anti-itch cream"
      ],
      "indications_and_usage": [
        "Uses Clear Shield: helps prevent sunburn Intensive Recovery: adults and children 2 years of age and older: For the temporary relief of minor skin irritations, rashes, itching and redness due to eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis (e.g. caused by soaps, detergents, cosmetics and/or jewelry), seborrheic dermatitis, psoriasis."
      ],
      "warnings": [
        "Warnings For external use only Do not use Clear Shield: on broken skin Intensive Recovery: for the treatment of diaper rash, except on the advice of a physician When using this product Clear Shield: avoid contact with eyes. If contact occurs, rinse thoroughly with water. Intensive Recovery: avoid contact with eyes, do not use in or around the eyes Stop use and ask a doctor Clear Shield: if rash occurs Intensive Recovery: if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. Do not begin use of any other hydrocortisone product unless directed by a physician. Keep out of reach of children If swallowed, call a Poison Control Centre or get medical help right away."
      ],
      "do_not_use": [
        "Do not use Clear Shield: on broken skin Intensive Recovery: for the treatment of diaper rash, except on the advice of a physician"
      ],
      "when_using": [
        "When using this product Clear Shield: avoid contact with eyes. If contact occurs, rinse thoroughly with water. Intensive Recovery: avoid contact with eyes, do not use in or around the eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor Clear Shield: if rash occurs Intensive Recovery: if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. Do not begin use of any other hydrocortisone product unless directed by a physician."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If swallowed, call a Poison Control Centre or get medical help right away."
      ],
      "dosage_and_administration": [
        "Directions Clear Shield: apply liberally/generously (and evenly) 15 minutes before sun exposure reapply at least every 2 hours 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 use a water resistant sunscreen if swimming or sweating Intensive Recovery: adults and children 2 years of age and older, apply sparingly to affected area not more than three to four times daily do not use on children under 2 years of age, consult a physician"
      ],
      "other_safety_information": [
        "Other Information Clear Shield: Store in a cool, dry place at room temperature. Do not use if security seal on box is broken or missing. You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701 Intensive Recovery: Do not use if security seal on box is broken or missing. You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701"
      ],
      "inactive_ingredient": [
        "Non-medicinal ingredients Clear Shield: Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Niacinamide, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Caprylyl Methicone, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, PEG-100 Stearate, Vitis Vinifera Seed Extract, Sodium Hyaluronate, Resveratrol, Lecithin, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Glutathione, Acacia Senegal Gum, Cellulose Gum, Microcrystalline Cellulose, Polysilicone-11, Triethoxycaprylylsilane, Ceteareth-20, Polyhydroxystearic Acid, Xanthan Gum, Disodium EDTA, Alumina, Tocopherol, Alteromonas Ferment Extract, Butylene Glycol, Physalis Angulata Extract, Polygonum Aviculare Extract, Xylitol, Caprylic Acid, Caprylyl Glycol, Polymethyl Methacrylate, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Pentylene Glycol, Ethylhexylglycerin. Intensive Recovery: Water/Aqua/Eau, Butyrospermum Parkii (Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Caprylic/Capric Triglyceride, Dimethicone, Propanediol, Theobroama Cacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Juice, Niacinamide, Resveratrol, Poria Cocos Sclerotium Extract, Boswellia Serrata Gum Extract, Honey Extract (Extait De. Miel), Tetrapeptide-14, Copper Tripeptide-1, Aspalathus Linearis Extract, Ceramide NP, Ceramide NG, Squalane, Hydrogenated Lecithin, Sodium Acrylates Copolymer, Lecithin, Behenyl Alchol, Xanthan Gum, Caprylic Acid, Sodium Methyl Stearoyl Taurate, Tricaprylin, Polymethyl Methacrylate, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Ethylhexylglycerin."
      ],
      "package_label_principal_display_panel": [
        "Product Packaging 2 2 2 1 1 1"
      ],
      "set_id": "2551d748-c3d6-cd18-e063-6294a90adab6",
      "id": "2551d9c3-b0ce-c683-e063-6294a90ad978",
      "effective_time": "20241025",
      "version": "1",
      "openfda": {
        "application_number": [
          "M020"
        ],
        "brand_name": [
          "Alumier MD Post Procedure Kit with Hydrocortisone"
        ],
        "generic_name": [
          "TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE"
        ],
        "manufacturer_name": [
          "Alumier Labs"
        ],
        "product_ndc": [
          "69473-020"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "rxcui": [
          "106258"
        ],
        "spl_id": [
          "2551d9c3-b0ce-c683-e063-6294a90ad978"
        ],
        "spl_set_id": [
          "2551d748-c3d6-cd18-e063-6294a90adab6"
        ],
        "package_ndc": [
          "69473-020-01"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}