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(from DailyMed)

SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY Avobenzone, Homosalate, Octisalate, and Octocrylene 1.295 g/50mL; 2.331 g/50mL; 2.331 g/50mL; 2.59 g/50mL Cream

by Shiseido Americas Corporation · 1 JAR in 1 CARTON (58411-017-50) / 50 mL in 1 JAR
NDC 58411-0017-50
🏷️ FDA NDC (as labeled) 58411-017-50 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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) 58411-017-50
Product NDC 58411-017
11-digit billing NDC 58411001750
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID cad3a446-36a8-4146-81b5-1cc8d65abf14
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-01
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 58411-017-50 — 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 → 58411-0017-50. 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

LabelerShiseido Americas Corporation
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58411
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio361 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 topical cream marketed as an over-the-counter sunscreen product under FDA's monograph rules for sunscreen ingredients. It contains four UV filters (avobenzone, homosalate, octisalate, and octocrylene) that are typically used to help protect skin from ultraviolet radiation when applied to the skin. The product is formulated as a day cream intended for facial use.

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.

💊 What it looks like

Color brown
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • 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.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 40RUH3S7RZ
    A plant extract from Angelica keiskei, a species native to East Asia. It functions as a flavoring agent and natural colorant in medicines, contributing taste and appearance to the formulation.
  • UNII 39YR661C4U
    A synthetic chemical compound used as a preservative in medicines to prevent bacterial and fungal growth, helping keep the product safe and effective during storage.
  • UNII BJ4GP2IFLN
    Beheneth-20 is a surfactant derived from behenic acid, a fatty acid. It helps mix oil and water-based ingredients together in formulations and can act as an emulsifier or solubilizer.
  • 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.
  • 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.
  • 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.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII RYQ4R60M02
    A green algae ingredient used as a natural colorant and nutritional filler in supplements and medications. It adds color and bulk to tablets and capsules.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII UY43O1Q45N
    A natural plant extract from citrus junos seeds, used as a preservative and antioxidant to help maintain the medicine's stability and prevent degradation over time.
  • 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 I445L28B12
    A silicone-based compound that acts as a lubricant and glidant in tablet and capsule formulations. It reduces friction between particles and on equipment surfaces, helping medicines flow smoothly during manufacturing and tablet compression.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII RA96B954X6
    Erythritol is a sugar alcohol derived from fermented fruits or grains. It's used as a sweetener and bulking agent in medicines to improve taste without adding significant calories.
  • 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 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.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII 6DNW9T7YT2
    A synthetic liquid polymer made from ethylene and propylene compounds. It acts as a solvent and humectant to help dissolve active ingredients and maintain moisture in the formulation.
  • UNII 4ET18WJG5K
    A synthetic liquid polymer made from ethylene glycol and propylene glycol components. Used in medications as a solvent to dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • 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.
  • UNII 233VSF903M
    A plant-derived oil compound used as an emollient and skin-conditioning agent. It helps soften the product texture and improve how the medicine spreads on or absorbs into the skin.
  • UNII EL9825H96J
    Polyquaternium-51 is a synthetic polymer used in topical medicines and cosmetics. It acts as a film-former and conditioning agent, helping the product coat and adhere to skin or mucous membranes.
  • UNII BI896CKT6B
    A plant extract from the tormentil root, used as a natural astringent and binding agent. It helps hold the medicine together and may provide texture or consistency to the formulation.
  • UNII 3D1P12PN9U
    Sapindus mukorossi fruit rind, also called soapnuts, is a natural plant material. It's used in formulations as a natural surfactant and foaming agent to help distribute and mix ingredients evenly.
  • 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.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII 532IUT7IRV
    A salt derived from phosphoric acid, sodium metaphosphate acts as a buffer and sequestrant in medicines. It helps stabilize the product and prevent unwanted chemical reactions during storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.
  • UNII YP632MQS35
    A polysaccharide (sugar-based polymer) produced by a bacterium, used as a thickener and stabilizer to give medicines a consistent texture and prevent separation of ingredients.
  • 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.
  • UNII 420IP921MB
    A chelating agent derived from edetic acid that binds to metals in the formulation. It helps stabilize the medicine by preventing metal ions from causing breakdown or discoloration.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII AQG914O70P
    A plant extract from the jujuba fruit tree, used as a natural sweetener, flavoring agent, and binder in medications to improve taste and help hold the formula together.

40 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesWater・Glycerin・Dipropylene Glycol・Dimethicone・Alcohol Denat.・C12-15 Alkyl Benzoate・Behenyl Alcohol・Butylene Glycol・Silica・Diphenylsiloxy Phenyl Trimethicone・Isododecane・Sorbitol・Stearyl Alcohol・Phytosteryl Macadamiate・Erythritol・Tocopheryl Acetate・PEG/PPG-14/7 Dimethyl Ether・PEG/PPG-17/4 Dimethyl Ether・Xanthan Gum・Caffeine・Sapindus Mukorossi Peel Extract・Angelica Keiskei Leaf/Stem Extract・Camellia Sinensis Leaf Extract・Citrus Junos Seed Extract・Ziziphus Jujuba Fruit Extract・Eucheuma Serra/Grateloupia Sparsa/Saccharina Angustata/Ulva Linza/Undaria Pinnatifida Extract・Potentilla Erecta Root Extract・Polyquaternium-51・Saccharina Angustata/Undaria Pinnatifida Extract・Chlorella Vulgaris Extract・Beheneth-20・Batyl Alcohol・Alcohol・Succinoglycan・Trisodium EDTA・Sodium Citrate・Sodium Metaphosphate・BHT・Citric Acid・Sodium Metabisulfite・PPG-3 Dipivalate・Tocopherol・Phenoxyethanol・Fragrance・Iron Oxides・

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 DailyMedingredient 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 systemPer gPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Shiseido Benefiance Wrinkle Smoothing Day 1.295 g/50mL; 2.331 g/50mL; 2.331 g/50mL; 2.59 g/50mLthis 58411-0017-50 Shiseido 1 jar 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 NDCDescription Marketing startStatus
58411-0017-50 You're viewing this 1 JAR in 1 CARTON (58411-017-50) / 50 mL in 1 JAR 2026-05-01 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 — Not published for this NDC No photo available yet for this listing.
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 58411-017-50, 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: 58411-0017-50, written without dashes as 58411001750. 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 58411-0017-50, the first segment (58411) is the labeler code FDA assigned to Shiseido Americas Corporation; the middle segment (0017) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Shiseido Americas Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shiseido Americas Corporation 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 4 words

Uses helps prevent sunburn

⏱️ Dosage and Administration 93 words

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 increase 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

⚠️ Warnings 5 words

Warnings For external use only

📦 Storage and Handling 14 words

Other information protect this product in this container from excessive heat and direct sun.

🧪 Inactive Ingredients 54 words

Water・Glycerin・Dipropylene Glycol・Dimethicone・Alcohol Denat.・C12-15 Alkyl Benzoate・Behenyl Alcohol・Butylene Glycol・Silica・Diphenylsiloxy Phenyl Trimethicone・Isododecane・Sorbitol・Stearyl Alcohol・Phytosteryl Macadamiate・Erythritol・Tocopheryl Acetate・PEG/PPG-14/7 Dimethyl Ether・PEG/PPG-17/4 Dimethyl Ether・Xanthan Gum・Caffeine・Sapindus Mukorossi Peel Extract・Angelica Keiskei Leaf/Stem Extract・Camellia Sinensis Leaf Extract・Citrus Junos Seed Extract・Ziziphus Jujuba Fruit Extract・Eucheuma Serra/Grateloupia Sparsa/Saccharina Angustata/Ulva Linza/Undaria Pinnatifida Extract・Potentilla Erecta Root Extract・Polyquaternium-51・Saccharina Angustata/Undaria Pinnatifida Extract・Chlorella Vulgaris Extract・Beheneth-20・Batyl Alcohol・Alcohol・Succinoglycan・Trisodium EDTA・Sodium Citrate・Sodium Metaphosphate・BHT・Citric Acid・Sodium Metabisulfite・PPG-3 Dipivalate・Tocopherol・Phenoxyethanol・Fragrance・Iron Oxides・

🎯 Purpose 15 words

Active Ingredients Purpose Avobenzone 2.5% Sunscreen Homosalate 4.5% Sunscreen Octisalate 4.5% Sunscreen Octocrylene 5.0% Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.