TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 ensulizole, octinoxate, octisalate, and zinc oxide 65 mg/mL; 30 mg/mL; 53 mg/mL; 27 mg/mL Emulsion
by TOM FORD BEAUTY DIST · 1 BOTTLE, PUMP in 1 CARTON (76398-015-01) / 30 mL in 1 BOTTLE, PUMP
NDC 76398-0015-01
🏷️ FDA NDC (as labeled)
76398-015-01
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
76398-015-01
Product NDC
76398-015
11-digit billing NDC
76398001501
UNII
4Y5P7MUD51, 4X49Y0596W, SOI2LOH54Z, 9YQ9DI1W42
Application #
M020
SPL Set ID
289b824f-bb0b-313e-e063-6394a90ab783
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-12-06
Route
TOPICAL
Dosage form
EMULSION
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE; ENSULIZOLE
Why two NDCs?
The FDA registers this code as 76398-015-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76398-0015-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏭 Manufacturer & labeler
LabelerTOM FORD BEAUTY DIST
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code76398
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio6 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
🧪 What is this product?
This is a liquid foundation emulsion applied to the skin that contains four active sunscreen ingredients: ensulizole, octinoxate, octisalate, and zinc oxide. These ingredients function as ultraviolet (UV) filters, commonly used in sunscreen products to help protect skin from UVA and UVB sun exposure. The product is formulated as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen products rather than being individually reviewed. The foundation base provides color and coverage while the SPF 50 rating indicates the level of sun protection.
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about ensulizole, octinoxate, octisalate, and zinc oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII L4EL31FWIL
A synthetic peptide (short chain of amino acids) used as a conditioning or texture-enhancing agent in topical formulations. It helps improve product feel and skin compatibility in creams and lotions.
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UNII 9E8X80D2L0
A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
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UNII F01RIY4371
A synthetic polymer made from acrylic compounds and taurate, this substance acts as a thickener and stabilizer. It helps give liquid medicines a smooth texture and keeps ingredients from separating.
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UNII 2V52R0NHXW
Ascorbyl glucoside is a stable form of vitamin C derived from ascorbic acid and glucose. It functions as an antioxidant in medicines to protect other ingredients from breaking down when exposed to air or light.
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UNII 9G1OE216XY
Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII 3XUS85K0RA
Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
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UNII WL3883U2PO
A natural resin derived from the caesalpinia spinosa plant, used as a binder and film-forming agent to help hold tablet ingredients together and create a protective coating on the medicine's surface.
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UNII 3G6A5W338E
Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
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UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII 035JKJ76MT
A silicone-based ingredient that helps oil and water mix together in formulations. It works as an emulsifier to create smooth, stable textures in topical medicines and creams.
-
UNII 97C5T2UQ7J
Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
-
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
-
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
-
UNII T3064TZ75A
A silicone-based polymer mixture used as an anti-foaming agent and skin protectant in topical formulations. It helps reduce surface bubbles during manufacturing and creates a smooth, water-resistant barrier on the skin.
-
UNII 9E4CO0W6C5
A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
-
UNII X687XDK09L
A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
-
UNII 8NLQ36F6MM
Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
-
UNII R5I1HK0UBL
A plant extract from geranium robertianum used as a natural flavoring agent and fragrance ingredient in medicines. It adds taste or aroma to improve how the medication tastes or smells.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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UNII 4CG9F9W01Q
A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
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UNII 5PWM7YLI7R
Barley is a grain plant. It may be used in some medicines as a filler or binder to add bulk and help hold the tablet or capsule together.
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UNII XDD37N2GPR
A fat derived from coconut oil that has been chemically treated to make it more stable. It works as a binder and lubricant to help hold the medicine together and improve how it flows during manufacturing.
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UNII MBQ7DDQ7AR
Hydroxyethyl urea is a synthetic organic compound used in medicines as a humectant and conditioning agent. It helps retain moisture in formulations and may improve texture or stability in topical products.
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UNII Z95S6G8201
A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
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UNII 25G622K2RA
A silicone-based surfactant that helps blend oil and water in cosmetic or topical formulations. It reduces surface tension to improve product spreadability and texture.
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UNII GFD7C86Q1W
A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
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UNII D81QY6I88E
Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
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UNII 9KJL21T0QJ
Linoleic acid is an omega-6 fatty acid derived from plant oils. It serves as an emulsifier and skin conditioning agent in topical formulations, helping ingredients mix smoothly and improving product texture.
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UNII 6777U11MKT
A silicone-based lubricant and anti-foaming agent used to reduce surface tension and prevent foam formation during manufacturing and storage of the medication.
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UNII V8A1AW0880
Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
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UNII 7829X3G2X5
A plant extract from the morinda citrifolia fruit, used as a natural flavoring agent and colorant in medicines. It may also provide antioxidant properties to help preserve the product's stability.
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UNII REM6A5QMC0
A plant-based oil extracted from moringa tree seeds. It's used in medicines as an emollient to soften and smooth the product, and sometimes as a natural carrier or conditioning agent in formulations.
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UNII 5LKW3C543X
A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.
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UNII 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
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UNII 2UMI9U37CP
Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
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UNII 2V16EO95H1
Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
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UNII F3VOA31UHQ
A natural oil extracted from passion fruit seeds. It serves as an emollient and skin-conditioning agent in topical products, helping to soften and moisturize the formulation while improving texture and spreadability.
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UNII HIE492ZZ3T
Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
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UNII DR0K5NOJ4R
Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
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UNII 820DPX33S7
A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
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UNII YXH47AOU0F
A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
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UNII 59Z907ZB69
A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
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UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
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UNII 66H9NW427Y
A natural extract from the soapberry fruit used as a cleansing agent and surfactant in topical formulations. It helps distribute active ingredients evenly and may serve as a natural preservative or emulsifier in the product.
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UNII II877K4UNR
A plant extract from the night-blooming cereus flower, used as a natural flavoring or fragrance agent in medicines to improve taste or aroma.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 8W46YN971G
Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
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UNII YSE9PPT4TH
Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
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UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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UNII GW89575KF9
Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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UNII MP1J8420LU
A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
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UNII R0ZB2556P8
Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
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UNII B8WCK70T7I
Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
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UNII LDC331P08E
A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
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UNII O05EC62663
A natural oil derived from glycerin and oleic acid. It acts as a lubricant and emollient in medicines, helping ingredients mix smoothly and improving how the product flows during manufacturing and application.
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UNII YR3G369F5A
Wheat germ is the nutrient-rich central part of the wheat kernel. It's used in medications as a natural filler and source of vitamins and oils that can help bind and preserve the product.
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UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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UNII 8617Z5FMF6
Whey is a milk-derived protein and carbohydrate byproduct. It functions as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the formulation.
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UNII C32PQ86DH4
Zinc PCA is a zinc salt of pyroglutamic acid, a naturally occurring amino acid derivative. It's used in medications as a skin-conditioning agent and to help maintain product stability and texture in topical formulations.
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UNII C5529G5JPQ
Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
72 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWATER\AQUA\EAU,DIMETHICONE,PHENYL TRIMETHICONE,BUTYLENE GLYCOL,GLYCERIN,NIACINAMIDE,TROMETHAMINE,POLYMETHYLSILSESQUIOXANE,ASCORBYL GLUCOSIDE,LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER,TRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMER,POLYSILICONE-11,CETYL PEG/PPG-10/1 DIMETHICONE,HEXYL LAURATE,ZINC PCA,NEOPENTYL GLYCOL DIHEPTANOATE,TOCOPHEROL,SODIUM HYALURONATE,SQUALANE,ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT,HORDEUM DISTICHON (BARLEY) EXTRACT\EXTRAIT D'ORGE À DEUX RANGS,TRITICUM VULGARE (WHEAT) GERM EXTRACT,CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT,GERANIUM ROBERTIANUM EXTRACT,SAPINDUS MUKOROSSI FRUIT EXTRACT,MORINDA CITRIFOLIA FRUIT EXTRACT,PASSIFLORA EDULIS SEED OIL,MORINGA OLEIFERA SEED OIL,HYDROGENATED COCO-GLYCERIDES,PHOSPHOLIPIDS,PHYTOSTERYL CANOLA GLYCERIDES,WHEY PROTEIN\LACTIS PROTEIN\PROTÉINE DU PETIT-LAIT,CAFFEINE,POLYGLYCERYL-4 ISOSTEARATE,CAPRYLIC/CAPRIC TRIGLYCERIDE,TREHALOSE,TRIETHYL CITRATE,CHOLESTEROL,LINOLEIC ACID,METHICONE,TRIOLEIN,CAESALPINIA SPINOSA GUM,ACETYL HEXAPEPTIDE-8,DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER,SILICA,DISTEARDIMONIUM HECTORITE,POLYHYDROXYSTEARIC ACID,HYDROXYETHYL UREA,GLYCERYL STEARATE,OLEIC ACID,STEARIC ACID,POLYSORBATE 80,POLYSORBATE 20,LECITHIN,LAURETH-7,PALMITIC ACID,CETEARYL ALCOHOL,AMMONIUM POLYACRYLOYLDIMETHYL TAURATE,STEARYL ALCOHOL,BEHENYL ALCOHOL,TRIETHOXYCAPRYLYLSILANE,FRAGRANCE (PARFUM),LIMONENE,LINALOOL,TOCOPHERYL ACETATE,BHT,TETRASODIUM EDTA,DISODIUM EDTA,PHENOXYETHANOL,SODIUM DEHYDROACETATE,POTASSIUM SORBATE, [+/- MICA,TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499)] <ILN53465>
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tom Ford Architecture Radiance Hydrating Foundation Broad Spectrum Spf 50 65 mg/mL; 30 mg/mL; 53 mg/mL; 27 mg/mLthis 76398-0015-01 | TOM | 1 bottle | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76398-0015-01 You're viewing this | 1 BOTTLE, PUMP in 1 CARTON (76398-015-01) / 30 mL in 1 BOTTLE, PUMP | 2024-12-06 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 76398-015-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76398-0015-01, written without dashes as 76398001501. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 76398-0015-01, the first segment (76398) is the labeler code FDA assigned to TOM FORD BEAUTY DIST; the middle segment (0015) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by TOM FORD BEAUTY DIST. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TOM FORD BEAUTY DIST is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
USE helps prevent sunburn
⏱️ Dosage and Administration ▾
Directions For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two 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 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 of age: ask a doctor
⚠️ 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 product is swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information protect the product in this container from excessive heat and direct sun
🧪 Active Ingredient ▾
Active Ingredients ENSULIZOLE 2.7% OCTINOXATE 6.5% OCTISALATE 3% ZINC OXIDE 5.3%
🧪 Inactive Ingredients ▾
Inactive Ingredients WATER\AQUA\EAU,DIMETHICONE,PHENYL TRIMETHICONE,BUTYLENE GLYCOL,GLYCERIN,NIACINAMIDE,TROMETHAMINE,POLYMETHYLSILSESQUIOXANE,ASCORBYL GLUCOSIDE,LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER,TRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMER,POLYSILICONE-11,CETYL PEG/PPG-10/1 DIMETHICONE,HEXYL LAURATE,ZINC PCA,NEOPENTYL GLYCOL DIHEPTANOATE,TOCOPHEROL,SODIUM HYALURONATE,SQUALANE,ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT,HORDEUM DISTICHON (BARLEY) EXTRACT\EXTRAIT D'ORGE À DEUX RANGS,TRITICUM VULGARE (WHEAT) GERM EXTRACT,CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT,GERANIUM ROBERTIANUM EXTRACT,SAPINDUS MUKOROSSI FRUIT EXTRACT,MORINDA CITRIFOLIA FRUIT EXTRACT,PASSIFLORA EDULIS SEED OIL,MORINGA OLEIFERA SEED OIL,HYDROGENATED COCO-GLYCERIDES,PHOSPHOLIPIDS,PHYTOSTERYL CANOLA GLYCERIDES,WHEY PROTEIN\LACTIS PROTEIN\PROTÉINE DU PETIT-LAIT,CAFFEINE,POLYGLYCERYL-4 ISOSTEARATE,CAPRYLIC/CAPRIC TRIGLYCERIDE,TREHALOSE,TRIETHYL CITRATE,CHOLESTEROL,LINOLEIC ACID,METHICONE,TRIOLEIN,CAESALPINIA SPINOSA GUM,ACETYL HEXAPEPTIDE-8,DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER,SILICA,DISTEARDIMONIUM HECTORITE,POLYHYDROXYSTEARIC ACID,HYDROXYETHYL UREA,GLYCERYL STEARATE,OLEIC ACID,STEARIC ACID,POLYSORBATE 80,POLYSORBATE 20,LECITHIN,LAURETH-7,PALMITIC ACID,CETEARYL ALCOHOL,AMMONIUM POLYACRYLOYLDIMETHYL TAURATE,STEARYL ALCOHOL,BEHENYL ALCOHOL,TRIETHOXYCAPRYLYLSILANE,FRAGRANCE (PARFUM),LIMONENE,LINALOOL,TOCOPHERYL ACETATE,BHT,TETRASODIUM EDTA,DISODIUM EDTA,PHENOXYETHANOL,SODIUM DEHYDROACETATE,POTASSIUM SORBATE, [+/- MICA,TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499)] <ILN53465>
🎯 Purpose ▾
Purpose Sunscreen
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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.