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SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 350 OCTINOXATE 2.30805 g/30mL Emulsion, 30 mL — NDC 58411-0875-40 package photo

SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 350 OCTINOXATE 2.30805 g/30mL Emulsion, 30 mL

by SHISEIDO AMERICAS CORPORATION · 1 CONTAINER in 1 CARTON (58411-875-40) / 30 mL in 1 CONTAINER
NDC 58411-0875-40
🏷️ FDA NDC (as labeled) 58411-875-40 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) 58411-875-40
Product NDC 58411-875
11-digit billing NDC 58411087540
UNII 4Y5P7MUD51
Application # M020
SPL Set ID 393ce1fa-f188-45d0-a23e-2818de974995
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-01
Route TOPICAL
Dosage form EMULSION
Substance OCTINOXATE
Why two NDCs? The FDA registers this code as 58411-875-40 — 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 → 58411-0875-40. 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 marketedAug 2023
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?

Shiseido Revitalessence Skin Glow Foundation is a liquid emulsion applied to the skin that contains octinoxate, an ultraviolet (UV) filter. This product functions as a cosmetic foundation with sun protection properties. Octinoxate is commonly used in sunscreens and tinted foundations to help absorb UVB rays and reduce sun exposure to the skin. As an OTC monograph product, it is marketed under the FDA's established rulebook for over-the-counter sunscreen ingredients rather than as an individually reviewed drug application.

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.

💊 What it looks like

Color White
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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • 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 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 LZ291VH90H
    A synthetic polymer used as a thickener and stabilizer in liquid and gel formulations. It increases viscosity to achieve the desired texture and helps keep ingredients uniformly mixed throughout the product.
  • 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 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 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 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.
  • 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 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 7D1YQ9Y5EZ
    Hydrogenated polybutene is a thick, wax-like ingredient made by chemically processing petroleum. It acts as a binder and lubricant, helping hold tablet ingredients together and allowing pills to slide smoothly during manufacturing and packaging.
  • 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • 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.
  • UNII ZEL54N6W95
    A silicone-based compound that helps oils and water mix together. Used in medicines as an emulsifier and anti-foaming agent to improve texture and prevent bubbles in liquids and creams.
  • UNII 02NG325BQG
    A synthetic oil made by chemically treating castor oil. It acts as a solubilizer and emulsifier to help mix water and oily ingredients together in liquid medicines.
  • UNII EHH90CO7TL
    A silicone-based ingredient combining polyethylene glycol and polypropylene glycol chains. It acts as an emulsifier and surfactant to help mix oil and water components, and reduces foam in liquid or semi-solid 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 4NYV2HT01X
    A plant extract from the roots of Sanguisorba officinalis (burnett). Used in formulations as a natural thickener, preservative, or conditioning agent to improve texture and stability.
  • UNII MNJ7VPT2R5
    A synthetic compound derived from amino acids and fatty acids, used as an emulsifier and surfactant. It helps blend oil and water-based ingredients together in formulations.
  • 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 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 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 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.

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

The official label also statesWATER･DIPHENYLSILOXY PHENYL TRIMETHICONE･DIPROPYLENE GLYCOL･GLYCERIN･NIACINAMIDE･ALCOHOL DENAT.･PEG-8･PEG-60 HYDROGENATED CASTOR OIL･LACTOBACILLUS/RICE FERMENT･AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER･TOCOPHERYL ACETATE･SODIUM DILAURAMIDOGLUTAMIDE LYSINE･MAGNESIUM CHLORIDE･POLYQUATERNIUM-51･LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL･SANGUISORBA OFFICINALIS ROOT EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･HYDROGENATED POLYISOBUTENE･PEG-12 DIMETHICONE･ISOSTEARIC ACID･POLYGLYCERYL-6 POLYRICINOLEATE･PEG-100 HYDROGENATED CASTOR OIL･BUTYLENE GLYCOL･ALUMINUM HYDROXIDE･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER･TRISODIUM EDTA･BHT･TOCOPHEROL･POTASSIUM HYDROXIDE･ALCOHOL･SODIUM METABISULFITE･PEG/PPG-19/19 DIMETHICONE･STEARIC ACID･PHENOXYETHANOL･TITANIUM DIOXIDE･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 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 mLPer 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 Revitalessence Skin Glow Foundation 150 2.30805 g/30mL 58411-0863-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 260 2.30805 g/30mL 58411-0870-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 410 2.30805 g/30mL 58411-0877-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 420 2.30805 g/30mL 58411-0878-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 440 2.30805 g/30mL 58411-0880-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 510 2.30805 g/30mL 58411-0883-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 520 2.30805 g/30mL 58411-0884-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 140 2.30805 g/30mL 58411-0862-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 430 2.30805 g/30mL 58411-0879-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 210 2.30805 g/30mL 58411-0865-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 220 2.30805 g/30mL 58411-0866-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 540 2.30805 g/30mL 58411-0886-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 320 2.30805 g/30mL 58411-0872-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 110 2.30805 g/30mL 58411-0859-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 230 2.30805 g/30mL 58411-0867-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 310 2.30805 g/30mL 58411-0871-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 350 2.30805 g/30mLthis 58411-0875-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 360 2.30805 g/30mL 58411-0876-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 450 2.30805 g/30mL 58411-0881-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 460 2.30805 g/30mL 58411-0882-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 530 2.30805 g/30mL 58411-0885-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 120 2.30805 g/30mL 58411-0860-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 130 2.30805 g/30mL 58411-0861-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 160 2.30805 g/30mL 58411-0864-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 250 2.30805 g/30mL 58411-0869-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 340 2.30805 g/30mL 58411-0874-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 550 2.30805 g/30mL 58411-0887-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 240 2.30805 g/30mL 58411-0868-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 330 2.30805 g/30mL 58411-0873-40 SHISEIDO 30 ml — — FDA listed —
Shiseido Revitalessence Skin Glow Foundation 560 2.30805 g/30mL 58411-0895-40 SHISEIDO 30 ml — — 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 350 (this brand).

Top reported reactions

Diverticulitis7
Anaphylactic Reaction6
Bronchiectasis6
Bursitis6
Diverticulum Intestinal6
Hypersensitivity6
Hyperthyroidism6

Reporter sex

8 reports
Male · 29%
Female · 71%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 5 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58411-0875-40 You're viewing this 1 CONTAINER in 1 CARTON (58411-875-40) / 30 mL in 1 CONTAINER 2023-08-01 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 58411-875-40, 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: 58411-0875-40, written without dashes as 58411087540. 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 58411-0875-40, the first segment (58411) is the labeler code FDA assigned to SHISEIDO AMERICAS CORPORATION; the middle segment (0875) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 30 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 94 words ▾

Directions For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

⚠️ Warnings 56 words ▾

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 14 words ▾

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

🧪 Active Ingredient 4 words ▾

Active ingredients OCTINOXATE 6.9%

🧪 Inactive Ingredients 48 words ▾

Inactive Ingredients WATER･DIPHENYLSILOXY PHENYL TRIMETHICONE･DIPROPYLENE GLYCOL･GLYCERIN･NIACINAMIDE･ALCOHOL DENAT.･PEG-8･PEG-60 HYDROGENATED CASTOR OIL･LACTOBACILLUS/RICE FERMENT･AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER･TOCOPHERYL ACETATE･SODIUM DILAURAMIDOGLUTAMIDE LYSINE･MAGNESIUM CHLORIDE･POLYQUATERNIUM-51･LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL･SANGUISORBA OFFICINALIS ROOT EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･HYDROGENATED POLYISOBUTENE･PEG-12 DIMETHICONE･ISOSTEARIC ACID･POLYGLYCERYL-6 POLYRICINOLEATE･PEG-100 HYDROGENATED CASTOR OIL･BUTYLENE GLYCOL･ALUMINUM HYDROXIDE･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER･TRISODIUM EDTA･BHT･TOCOPHEROL･POTASSIUM HYDROXIDE･ALCOHOL･SODIUM METABISULFITE･PEG/PPG-19/19 DIMETHICONE･STEARIC ACID･PHENOXYETHANOL･TITANIUM DIOXIDE･IRON OXIDES･

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58411-0874-40 · SHISEIDO 58411-0876-40 · 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.