SHISEIDO WASO COLOR-SMART DAY MOISTURIZER OCTINOXATE, TITANIUM DIOXIDE 4.255 g/50mL; 3.0475 g/50mL Cream — NDC 58411-0966-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SHISEIDO WASO COLOR-SMART DAY MOISTURIZER OCTINOXATE, TITANIUM DIOXIDE 4.255 g/50mL; 3.0475 g/50mL Cream — NDC 58411-966-60 (Billing 58411-0966-60)

by Shiseido Americas Corporation · 1 TUBE in 1 BOX / 50 mL in 1 TUBE

This is a package of SHISEIDO WASO COLOR-SMART DAY MOISTURIZER OCTINOXATE, TITANIUM DIOXIDE 4.255 g/50mL; 3.0475 g/50mL Cream from Shiseido Americas Corporation, marketed since Sep 2018 and currently FDA-listed. It is this product's only package size.

NDC 58411-0966-60
🏷️ FDA NDC (as labeled) 58411-966-60 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 58411-966-60 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58411 labeler · 966 product · 60 package
Package marketed since
Sep 1, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5841196660 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58411-966-60
Product NDC 58411-966
11-digit billing NDC 58411096660
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M040
SPL Set ID 54f63dd8-e77f-42e4-a6d3-61ab7beecf50
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-09-01
Route TOPICAL
Dosage form CREAM
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 58411-966-60 — 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 → 58411-0966-60. 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.

Clinical

🧪 What is this product?

This is an over-the-counter moisturizing cream applied to the face, marketed under FDA's monograph rules for sunscreen products. It contains octinoxate and titanium dioxide, which are ultraviolet light filters commonly used in sunscreen formulations to help protect skin from UV rays. The product is intended as a daily facial moisturizer with sun-protective ingredients.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58411-0966-60 You're viewing this Main listing 1 TUBE in 1 BOX / 50 mL in 1 TUBE 2018-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Shiseido Waso Color-Smart Day Moisturizer 4.255 g/50mL; 3.0475 g/50mLthis 58411-0966-60 Shiseido 1 tube — — 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 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.

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 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • 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 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 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 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • 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 10525P22U0
    Diglycine is a small peptide made of two amino acids joined together. It acts as a buffer and pH stabilizer in medications, helping keep the product at the right acidity level for effectiveness and stability.
  • 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 Z02066SV11
    A plant extract from loquat leaves used as a natural flavoring and soothing ingredient in medicines. It may help mask bitter tastes and provide mild aromatic or demulcent properties in liquid formulations.
  • 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 4QGR4P2YOI
    A silicone-based lubricant that reduces friction between tablet particles and manufacturing equipment. It helps tablets flow smoothly during production and prevents them from sticking together or to machinery.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII T95771X2XI
    Lamium album flowering top is a plant-derived ingredient used as a natural flavoring or coloring agent in some medicines. It may also serve as a botanical extract to support the product's formulation.
  • 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.
  • 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.
  • UNII 3Z3866YW6P
    A plant extract from peony root used in traditional herbal formulations. It may function as a flavoring agent, natural colorant, or botanical ingredient to support the product's herbal composition.
  • UNII 8PR7V1SVM0
    A silicone-based lubricant combined with polyethylene glycol. It reduces friction and helps the medicine flow smoothly during manufacturing and improves how the product feels when applied or swallowed.
  • 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 65954KGO9Q
    A plant-derived emulsifier made from phytosterols and fatty acids. It helps mix oil and water-based ingredients together and improves texture and spreadability in topical formulations.
  • 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.
  • 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 EU2PSP0G0W
    Silica dimethyl silylate is a silicon-based powder that acts as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during manufacturing and tablet compression.
  • 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.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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 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.
  • 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.
  • UNII 5041RX63GN
    A synthetic silicon-based polymer used as a glidant and anti-caking agent. It helps powder particles flow smoothly and prevents clumping during manufacturing and 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.

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

The official label also statesWATER・CYCLOPENTASILOXANE・SD ALCOHOL 40-B・GLYCERIN・METHYL METHACRYLATE CROSSPOLYMER・DIMETHICONE・PEG-10 DIMETHICONE・POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER・LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE・POLYMETHYLSILSESQUIOXANE・TALC・ERYTHRITOL・SILICA・TREHALOSE・DISTEARDIMONIUM HECTORITE・TRIMETHYLSILOXYSILICATE・CAFFEINE・BETAINE・PEG/PPG-17/4 DIMETHYL ETHER・PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE・DIPEPTIDE-15・ERIOBOTRYA JAPONICA LEAF PROTOPLASTS・PAEONIA ALBIFLORA ROOT EXTRACT・LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT・CITRUS JUNOS SEED EXTRACT・ERIOBOTRYA JAPONICA LEAF EXTRACT・ALUMINUM HYDROXIDE・STEARIC ACID・ISOSTEARIC ACID・BUTYLENE GLYCOL・TRISODIUM EDTA・POLYESTER-1・ALCOHOL・SILICA DIMETHYL SILYLATE・ALUMINA・TRIETHOXYCAPRYLYLSILANE・HYDROGEN DIMETHICONE・BHT・TOCOPHEROL・PHENOXYETHANOL・BENZOIC ACID・FRAGRANCE・TITANIUM DIOXIDE・IRON OXIDES・MICA・

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.

Manufacturer & labeler

LabelerShiseido Americas Corporation
FDA applicationM040 (OTC MONOGRAPH DRUG)
Labeler code58411
First marketedSep 2018
Product typeHuman Otc Drug
Portfolio361 products on file

More NDCs from Shiseido Americas Corporation labeler code 58411

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.

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 29 words ▾

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

⏱️ Dosage and Administration 91 words ▾

Directions apply liberally 15 minutes before sun exposure use a water resistant sun screen 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 of 15 or higher and other sun protection measures including: -limit time in the sun, especially from 10 a.m. - 2p.m. -wear long-sleeve shirts, pant, 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 44 words ▾

Inactive Ingredients WATER・CYCLOPENTASILOXANE・SD ALCOHOL 40-B・GLYCERIN・METHYL METHACRYLATE CROSSPOLYMER・DIMETHICONE・PEG-10 DIMETHICONE・POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER・LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE・POLYMETHYLSILSESQUIOXANE・TALC・ERYTHRITOL・SILICA・TREHALOSE・DISTEARDIMONIUM HECTORITE・TRIMETHYLSILOXYSILICATE・CAFFEINE・BETAINE・PEG/PPG-17/4 DIMETHYL ETHER・PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE・DIPEPTIDE-15・ERIOBOTRYA JAPONICA LEAF PROTOPLASTS・PAEONIA ALBIFLORA ROOT EXTRACT・LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT・CITRUS JUNOS SEED EXTRACT・ERIOBOTRYA JAPONICA LEAF EXTRACT・ALUMINUM HYDROXIDE・STEARIC ACID・ISOSTEARIC ACID・BUTYLENE GLYCOL・TRISODIUM EDTA・POLYESTER-1・ALCOHOL・SILICA DIMETHYL SILYLATE・ALUMINA・TRIETHOXYCAPRYLYLSILANE・HYDROGEN DIMETHICONE・BHT・TOCOPHEROL・PHENOXYETHANOL・BENZOIC ACID・FRAGRANCE・TITANIUM DIOXIDE・IRON OXIDES・MICA・

🎯 Purpose 10 words ▾

Active Ingredients Purpose OCTINOXATE 7.4% Sunscreen TITANIUM DIOXIDE 5.3% Sunscreen

📄 Do Not Use 19 words ▾

Do not use on damaged or broken skin

Flammable . Do not use near heat, flame, or while smoking

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 6 words ▾

Questions or Comments? Call toll free-1-800-906-7503

📄 Package Label / Principal Display Panel 25 words ▾

PRINCIPLE DISPLAY PANEL- 50 mL WASO SHISEIDO GINZA TOKYO COLOR-SMART DAY MOISTURIZER OIL- FREE BROAD SPECTRUM SPF-30 SUNSCREEN 50 mL NET WT.1.9 OZ image description

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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
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.