Home › NDC Lookup › Ingredients › Octisalate, Octocrylene, Zinc Oxide › 58411-0971-60
SHISEIDO ULTIMATE SUN PROTECTOR OCTISALATE, OCTOCRYLENE, ZINC OXIDE 1.8105 g/50mL; 1.8105 g/50mL; 11.7079 g/50mL Cream — NDC 58411-0971-60 package photo

SHISEIDO ULTIMATE SUN PROTECTOR OCTISALATE, OCTOCRYLENE, ZINC OXIDE 1.8105 g/50mL; 1.8105 g/50mL; 11.7079 g/50mL Cream

by Shiseido Americas Corporation · 1 TUBE in 1 BOX (58411-971-60) / 50 mL in 1 TUBE
NDC 58411-0971-60
🏷️ FDA NDC (as labeled) 58411-971-60 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 58411-971-60
Product NDC 58411-971
11-digit billing NDC 58411097160
UNII 5A68WGF6WM, 4X49Y0596W, SOI2LOH54Z
Application # M020
SPL Set ID ce6a28c1-56e6-4105-bc9d-9d1986ead420
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-01
Route TOPICAL
Dosage form CREAM
Substance OCTOCRYLENE; OCTISALATE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 58411-971-60 — 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 → 58411-0971-60. 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.

🏭 Manufacturer & labeler

LabelerShiseido Americas Corporation
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58411
First marketedMar 2025
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 sunscreen product marketed as an over-the-counter monograph drug. It contains three active ingredients that work together to protect skin from ultraviolet radiation: octisalate and octocrylene are chemical UV filters that absorb sunlight, while zinc oxide is a physical UV filter that reflects and scatters rays away from the skin. Products of this type are typically used to help reduce sun exposure and the associated skin damage that can result from prolonged time outdoors.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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 5L08GE4332
    Hypotaurine is an organic compound and precursor to taurine, a naturally occurring amino acid. It may be used in formulations as a buffer or antioxidant to help stabilize the medication and maintain its effectiveness over time.
  • 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 I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII 89B2BSF9I3
    A synthetic compound made by chemically combining corn dextrin (a starch derivative) with palmitic acid. It acts as a binder and flow agent, helping hold tablet ingredients together and improve powder handling during manufacturing.
  • UNII J8T3X564IH
    A clear oily liquid derived from sebacic acid, used as a plasticizer and solvent in pharmaceutical coatings and films to improve flexibility and help active ingredients dissolve properly.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • 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 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 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 MG58AH4FJ8
    Hypromellose 2208 is a plant-based thickener and film-former made from cellulose. It's used in medicines as a coating on tablets and capsules to control how quickly the drug releases, and to improve how the medicine flows during manufacturing.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 LM6Q66468X
    A synthetic polymer made from polyethylene glycol and polypropylene glycol combined with dimethyl ether. Used as a solvent and humectant to help dissolve active ingredients and retain moisture in topical formulations.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • UNII O3TMV4903H
    A plant extract from saxifraga stolonifera (creeping saxifrage), used as a natural flavoring agent or botanical additive in medicines to enhance taste or provide mild plant-based properties to the formulation.
  • 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 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.
  • 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 IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • 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 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 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 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.

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

The official label also statesWATER･DIISOPROPYL SEBACATE･ISOPROPYL MYRISTATE･ALCOHOL DENAT.･PEG/PPG-9/2 DIMETHYL ETHER･GLYCERIN･ALCOHOL･PPG-3 DIPIVALATE･TALC･POLYGLYCERYL-6 POLYRICINOLEATE･SILICA･DEXTRIN PALMITATE･DEXTRIN PALMITATE/ETHYLHEXANOATE･ACRYLAMIDES/DMAPA ACRYLATES/METHOXY PEG METHACRYLATE COPOLYMER･DIPOTASSIUM GLYCYRRHIZATE･AMINOETHANESULFINIC ACID･PEG/PPG-14/7 DIMETHYL ETHER･SAXIFRAGA SARMENTOSA EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SODIUM HYALURONATE･SOPHORA ANGUSTIFOLIA ROOT EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･HYDROGEN DIMETHICONE･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･SUCCINOGLYCAN･TOCOPHEROL･BHT･BUTYLENE GLYCOL･STEARIC ACID･SODIUM METABISULFITE･PEG-6･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SYZYGIUM JAMBOS LEAF EXTRACT･CHLORPHENESIN･FRAGRANCE

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 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 Ultimate Sun Protector 1.8105 g/50mL; 1.8105 g/50mL; 11.7079 g/50mLthis 58411-0971-60 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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 NDCDescription Marketing startStatus
58411-0971-60 You're viewing this 1 TUBE in 1 BOX (58411-971-60) / 50 mL in 1 TUBE 2025-03-01 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 ✓ 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 58411-971-60, 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: 58411-0971-60, written without dashes as 58411097160. 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 58411-0971-60, the first segment (58411) is the labeler code FDA assigned to Shiseido Americas Corporation; the middle segment (0971) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 4 words ▾

Uses helps prevent sunburn

⏱️ Dosage and Administration 92 words ▾

Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying 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 16 words ▾

Warnings For external use only

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

📦 Storage and Handling 14 words ▾

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

🧪 Inactive Ingredients 49 words ▾

WATER･DIISOPROPYL SEBACATE･ISOPROPYL MYRISTATE･ALCOHOL DENAT.･PEG/PPG-9/2 DIMETHYL ETHER･GLYCERIN･ALCOHOL･PPG-3 DIPIVALATE･TALC･POLYGLYCERYL-6 POLYRICINOLEATE･SILICA･DEXTRIN PALMITATE･DEXTRIN PALMITATE/ETHYLHEXANOATE･ACRYLAMIDES/DMAPA ACRYLATES/METHOXY PEG METHACRYLATE COPOLYMER･DIPOTASSIUM GLYCYRRHIZATE･AMINOETHANESULFINIC ACID･PEG/PPG-14/7 DIMETHYL ETHER･SAXIFRAGA SARMENTOSA EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SODIUM HYALURONATE･SOPHORA ANGUSTIFOLIA ROOT EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･HYDROGEN DIMETHICONE･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･SUCCINOGLYCAN･TOCOPHEROL･BHT･BUTYLENE GLYCOL･STEARIC ACID･SODIUM METABISULFITE･PEG-6･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SYZYGIUM JAMBOS LEAF EXTRACT･CHLORPHENESIN･FRAGRANCE

🎯 Purpose 11 words ▾

Active ingredients Purpose Octisalate 3.0% Sunscreen Octocrylene 3.0% Zinc Oxide 19.4%

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58411-0970-60 · Shiseido 58411-0973-60 · Shiseido →
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.