{
"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,
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}
},
"results": [
{
"spl_product_data_elements": [
"Obagi Nu-Derm FX System Normal - Oily Skin Transformation Complexion Brightening System Homosalate, Octisalate, and Zinc Oxide NU-DERM FOAMING WATER PHENOXYETHANOL METHYLPARABEN PROPYLPARABEN BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN FD&C YELLOW NO. 5 SODIUM LAUROYL OAT AMINO ACIDS COCAMIDOPROPYL BETAINE SODIUM LAURETH-3 SULFATE ALOE VERA LEAF SODIUM CHLORIDE MEDICAGO SATIVA WHOLE CHAMOMILE XANTHAN GUM D&C RED NO. 33 RED NU-DERM TONER 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 BLUE NU-DERM CLEAR FX SKIN BRIGHTENING WATER ARBUTIN CETYL ALCOHOL GLYCERIN SODIUM LAURYL SULFATE STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE BUTYLATED HYDROXYTOLUENE LACTIC ACID, UNSPECIFIED FORM EDETATE DISODIUM ANHYDROUS BUTYLPARABEN METHYLPARABEN PROPYLPARABEN WHITE NU-DERM EXFODERM FORTE EXFOLIATION ENHANCER WATER GLYCERIN DIMETHICONE METHYLPARABEN PROPYLPARABEN POLYSORBATE 60 TROLAMINE MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL CETYL ALCOHOL LACTIC ACID, UNSPECIFIED FORM EMU OIL STEARIC ACID STEARYL ALCOHOL GLYCOLIC ACID WHITE NU-DERM HYDRATE FACIAL MOISTURIZER 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 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 WHITE NU-DERM BLEND FX Skin Brightener and Blending WATER GLYCERIN CETYL ALCOHOL ARBUTIN PPG-2 MYRISTYL ETHER PROPIONATE SODIUM LAURYL SULFATE TROLAMINE SALICYLATE .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID LACTIC ACID, UNSPECIFIED FORM PHENYL TRIMETHICONE SODIUM METABISULFITE BUTYLATED HYDROXYTOLUENE EDETATE DISODIUM ANHYDROUS METHYLPARABEN PROPYLPARABEN WHITE NU-DERM 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 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": [
"| Active ingredients | Purpose |
|---|
| Homosalate 10% | Sunscreen |
| Octisalate 5% | Sunscreen |
| Zinc Oxide 16.5% | Sunscreen |
"
],
"purpose": [
"Active ingredients Purpose Homosalate 10% Sunscreen Octisalate 5% Sunscreen Zinc Oxide 16.5% Sunscreen"
],
"purpose_table": [
"| Active ingredients | Purpose |
|---|
| Homosalate 10% | Sunscreen |
| Octisalate 5% | Sunscreen |
| Zinc Oxide 16.5% | 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 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 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone"
],
"questions": [
"Questions or comments? 1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - Kit Carton OBAGI ® MEDICAL OBAGI NU-DERM FX™ SYSTEM NORMAL OILY Skin Transformation Kit Complexion Brightening System Principal Display Panel - Kit Carton"
],
"set_id": "04cec275-161a-41d2-b171-33d11f15d324",
"id": "4fe691d6-0f60-499a-96b5-33f7eb291da1",
"effective_time": "20250402",
"version": "3",
"openfda": {
"brand_name": [
"Obagi Nu-Derm FX System Normal - Oily Skin Transformation Complexion Brightening System"
],
"generic_name": [
"HOMOSALATE, OCTISALATE, AND ZINC OXIDE"
],
"manufacturer_name": [
"Obagi Cosmeceuticals LLC"
],
"product_ndc": [
"62032-538"
],
"product_type": [
"HUMAN OTC DRUG"
],
"spl_id": [
"4fe691d6-0f60-499a-96b5-33f7eb291da1"
],
"spl_set_id": [
"04cec275-161a-41d2-b171-33d11f15d324"
],
"package_ndc": [
"62032-538-91"
],
"is_original_packager": [
true
]
}
}
]
}