{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Obagi Nu-Derm System Normal-Dry Skin Transformation Kit Hydroquinone, Homosalate, Octisalate, Zinc Oxide NU-DERM GENTLE CLEANSER Cosmetic WATER GLYCERIN PHENOXYETHANOL METHYLPARABEN PROPYLPARABEN BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM LAUROYL OAT AMINO ACIDS COCAMIDOPROPYL BETAINE SODIUM LAURETH-3 SULFATE ALOE VERA LEAF GLYCERETH-7 PANTHENOL DIETHYLENE GLYCOL MONOETHYL ETHER TROLAMINE SAGE FD&C YELLOW NO. 5 APRICOT KERNEL OIL OLEYL LACTATE NU-DERM TONER Cosmetic WATER GLYCERIN HAMAMELIS VIRGINIANA TOP WATER SODIUM PYRROLIDONE CARBOXYLATE DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE POTASSIUM ALUM PANTHENOL SAGE CALENDULA OFFICINALIS FLOWER POLYSORBATE 80 ALLANTOIN ALOE VERA LEAF FD&C BLUE NO. 1 NU-DERM CLEAR Skin Bleaching and Corrector HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM BUTYLPARABEN STEARYL ALCOHOL SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE NU-DERM EXFODERM Skin Smoothing Cosmetic WATER GLYCERIN METHYLPARABEN PROPYLPARABEN POLYSORBATE 60 CETOSTEARYL ALCOHOL STEARETH-20 CANOLA OIL ISOHEXADECANE MAGNESIUM ALUMINUM SILICATE CETYL ALCOHOL FYTIC ACID GLYCERYL MONOSTEARATE PEG-100 MONOSTEARATE DIMETHICONE, UNSPECIFIED PEG-150 STEARATE PHENOXYETHANOL BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN POTASSIUM CETYL PHOSPHATE XANTHAN GUM .ALPHA.-TOCOPHEROL ACETATE GLYCERETH-7 DIETHYLENE GLYCOL MONOETHYL ETHER BIS-DIGLYCERYL POLYACYLADIPATE-2 SODIUM HYDROXIDE NU-DERM HYDRATE FACIAL MOISTURIZER Cosmetic WATER GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES SODIUM HYDROXIDE TARA SPINOSA RESIN SHEA BUTTER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CYCLOMETHICONE 5 CETYL ALCOHOL SACCHARIDE ISOMERATE DIMETHICONE, UNSPECIFIED TOCOPHEROL LAURETH-12 PHENOXYETHANOL ETHYLHEXYLGLYCERIN STEARIC ACID AVOCADO OIL SOY STEROL CAPRYLYL GLYCOL LEVOMENOL HEXYLENE GLYCOL TETRAHYDRODIFERULOYLMETHANE PANTHENOL MANGIFERA INDICA SEED BUTTER SODIUM STEAROYL GLUTAMATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ALLANTOIN GLYCERYL MONOSTEARATE NU-DERM BLENDER Skin Lightener and Blending HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM PPG-2 MYRISTYL ETHER PROPIONATE TROLAMINE SALICYLATE SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE PHENYL TRIMETHICONE SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN HOMOSALATE, OCTISALATE, AND ZINC OXIDE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE ZINC OXIDE ZINC OXIDE WATER GLYCERIN HYDROXYACETOPHENONE XANTHAN GUM SODIUM CHLORIDE SODIUM HYDROXIDE OCTYLDODECYL NEOPENTANOATE TRIETHOXYCAPRYLYLSILANE C15-19 ALKANE DISTEARDIMONIUM HECTORITE POLYGLYCERYL-2 ISOSTEARATE SORBITAN OLIVATE DIMETHICONE, UNSPECIFIED 1,2-HEXANEDIOL CAPRYLYL GLYCOL EDETATE DISODIUM CANDELILLA WAX YELLOW WAX POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) SILICON DIOXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Homosalate 10% Sunscreen Octisalate 5% Sunscreen Zinc Oxide 16.5% Sunscreen"
      ],
      "active_ingredient_table": [
        "<table width=\"50%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"right\" valign=\"top\"/><thead><tr><th styleCode=\"italics\">Active ingredients</th><th styleCode=\"italics\">Purpose</th></tr></thead><tbody><tr><td>Homosalate 10%</td><td>Sunscreen</td></tr><tr><td>Octisalate 5%</td><td>Sunscreen</td></tr><tr><td>Zinc Oxide 16.5%</td><td>Sunscreen</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purpose Homosalate 10% Sunscreen Octisalate 5% Sunscreen Zinc Oxide 16.5% Sunscreen"
      ],
      "purpose_table": [
        "<table width=\"50%\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"right\" valign=\"top\"/><thead><tr><th styleCode=\"italics\">Active ingredients</th><th styleCode=\"italics\">Purpose</th></tr></thead><tbody><tr><td>Homosalate 10%</td><td>Sunscreen</td></tr><tr><td>Octisalate 5%</td><td>Sunscreen</td></tr><tr><td>Zinc Oxide 16.5%</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 Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. 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"
      ],
      "stop_use": [
        "Stop use and ask a doctor if rash occurs"
      ],
      "when_using": [
        "When using this product keep out of eyes. Rinse with water to remove."
      ],
      "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 use a water resistant sunscreen if swimming or sweating 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 children under 6 months: Ask a doctor"
      ],
      "storage_and_handling": [
        "Other information store at controlled room temperature: 15°C–25°C (59°F–77°F) protect this product from excessive heat and direct sun"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (Candelilla) Wax, Beeswax (Cera Alba), Dimethicone"
      ],
      "questions": [
        "Questions or comments? 1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. PST"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - Kit Carton OBAGI ® MEDICAL OBAGI NU-DERM ® SYSTEM Addresses signs of skin aging, gently exfoliates to promote cell turnover and suppresses melanocyte activity to reduce hyperpigmentaion. NORMAL DRY Skin Transformation Kit PRINCIPAL DISPLAY PANEL - Kit Carton"
      ],
      "set_id": "16efa2db-8172-4026-a519-08f53d68b3c9",
      "id": "6feb35fd-243a-4a73-8206-84a3fd9ccd6f",
      "effective_time": "20251023",
      "version": "4",
      "openfda": {
        "brand_name": [
          "Obagi Nu-Derm System Normal-Dry Skin Transformation Kit"
        ],
        "generic_name": [
          "HYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Obagi Cosmeceuticals LLC"
        ],
        "product_ndc": [
          "62032-911"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "197795"
        ],
        "spl_id": [
          "6feb35fd-243a-4a73-8206-84a3fd9ccd6f"
        ],
        "spl_set_id": [
          "16efa2db-8172-4026-a519-08f53d68b3c9"
        ],
        "package_ndc": [
          "62032-911-01",
          "62032-101-36",
          "62032-100-36",
          "62032-140-09"
        ],
        "is_original_packager": [
          true
        ]
      }
    }
  ]
}