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cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50 OCTINOXATE and TITANIUM DIOXIDE 1.715 g/35mL; 1.155 g/35mL Emulsion — NDC 58411-0013-20 package photo

cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50 OCTINOXATE and TITANIUM DIOXIDE 1.715 g/35mL; 1.155 g/35mL Emulsion

by SHISEIDO AMERICAS CORPORATION · 35 VIAL in 1 CARTON (58411-013-20) / 35 mL in 1 VIAL (58411-013-70)
NDC 58411-0013-20
🏷️ FDA NDC (as labeled) 58411-013-20 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 20, 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) 58411-013-20
Product NDC 58411-013
11-digit billing NDC 58411001320
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M020
SPL Set ID 4490f968-46b6-44d2-af2d-5130b52c8861
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-01
Route TOPICAL
Dosage form EMULSION
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 58411-013-20 — 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 → 58411-0013-20. 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 marketedJan 2021
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?

Cle de Peau Beaute Radiant Fluid Foundation is a liquid makeup emulsion applied to the skin that contains two active sunscreen ingredients: octinoxate and titanium dioxide. These are ultraviolet (UV) filters typically used in cosmetic and personal-care products to help protect skin from sun exposure. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen products rather than undergoing individual approval.

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 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 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 3W51R3EK30
    A plant extract from angelica root used in traditional Asian medicine preparations. It may serve as a flavoring agent, fragrance component, or natural additive in herbal formulations.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII 25BB7EKE2E
    Barium sulfate is a white powder mineral compound used as a filler and opacifying agent in tablets and capsules. It adds bulk to the medicine and may be included in formulations for imaging purposes.
  • UNII 366D9UAY69
    A waxy, fatty substance derived from plant or animal sources. In medicines, it typically acts as a lubricant or glidant to help powder ingredients flow smoothly during manufacturing and tablet production.
  • UNII YG6YAQ6XCX
    A silicone-based chemical compound that acts as a glidant and lubricant in tablet and powder formulations. It reduces friction between particles and equipment surfaces, helping medicine flow smoothly during manufacturing and improving tablet compression.
  • UNII 1N032N7MFO
    A brown-colored mineral form of iron oxide used as a colorant in tablets and capsules. It gives medicines their brown or tan appearance without affecting how the drug works.
  • 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 Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII DSO12WL7AU
    A salt derived from citric acid, this ingredient acts as a buffer and pH regulator in medicines. It helps maintain stable acidity levels and may improve taste or aid preservation.
  • 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 JXU526QH1V
    A natural plant extract from quince seeds, used as a binder and thickener to help hold the medicine together and create the right texture in tablets or liquids.
  • UNII QBS8A3XZGQ
    A synthetic oil made from diisostearyl alcohol and malic acid. It serves as an emollient and solvent in formulations, helping to dissolve and deliver active ingredients while improving texture and spreadability.
  • 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 21AS8B1BSS
    A silicone-based ingredient that combines dimethicone (silicone oil) with polyethylene glycol. It works as a skin-conditioning agent and texture enhancer, helping smooth the product's feel and improve how it spreads on skin.
  • UNII H895X08VNQ
    A silicone-based polymer that forms small, hard particles. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • 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 45ASM2L11M
    A synthetic ingredient derived from glutamic acid and stearic acid. It acts as an emulsifier and surfactant, helping oils and water mix smoothly in the medication formulation.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII 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 4TJZ1118I8
    A red colorant derived from the cochineal insect or made synthetically. It adds color to medicines and helps identify the product.
  • UNII 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • 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 TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 2428CXY2LA
    A protein derived from goat hair that's been broken down into smaller pieces through enzymes. Used as a film-former and binder to help hold tablet or capsule ingredients together.
  • UNII R6K7AW17SU
    A protein derived from sheep wool that has been broken down into smaller molecules. It functions as a film-former and conditioning agent, helping to create protective coatings and improve texture in topical formulations.
  • 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 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 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 YK3DC63Y5M
    A mineral compound derived from natural or synthetic sources that acts as an anti-caking agent and flow aid. It helps prevent clumping and improves the powder's ability to flow smoothly during manufacturing and tablet formation.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 287GF3Y3WC
    PEG-10 Dimethicone is a silicone-based compound that acts as an emulsifier and surfactant in medicines. It helps blend water and oil-based ingredients together and reduces surface tension to improve how the product spreads and feels.
  • 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 T4L5881Y68
    A plant-derived ingredient from perilla leaves, used as a natural flavoring agent and to provide potential sensory or aromatic qualities to the medicine.
  • 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 Z570VEV8XK
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles so the medicine flows smoothly during manufacturing and remains free-flowing in the bottle.
  • UNII F8DRP5BB29
    A silicone-based polymer that acts as an emulsifier and skin-conditioning agent. It helps blend oil and water ingredients together and improves the texture and feel of topical formulations.
  • UNII CVT1AA87FF
    A plant extract from Rosa roxburghii fruit (also called chestnut rose), used as a natural flavoring agent, colorant, or antioxidant in medicines to improve taste and help preserve the product.
  • 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 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 8021PR16QO
    Theanine is an amino acid found naturally in tea leaves. In medications, it's typically used as an active ingredient for its potential calming effects, though it may also function as a flavor component or dietary supplement ingredient in some formulations.
  • 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 X75PL53TZJ
    A silicone-based polymer that functions as a glidant and anti-caking agent, helping the medicine powder flow smoothly during manufacturing and preventing clumping in the final product.
  • 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 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 VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

The official label also statesWATER･DIMETHICONE･GLYCERIN･BUTYLENE GLYCOL･TRIMETHYLSILOXYSILICATE･POLYMETHYLSILSESQUIOXANE･ISODODECANE･CAPRYLYL METHICONE･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･PEG-10 DIMETHICONE･ISOPROPYL MYRISTATE･SYNTHETIC FLUORPHLOGOPITE･DIMETHICONE/PEG-10/15 CROSSPOLYMER･ERYTHRITOL･XYLITOL･BARIUM SULFATE･PYRUS CYDONIA SEED EXTRACT･TREHALOSE･ARGANIA SPINOSA KERNEL OIL･GLYCINE･PEG/PPG-14/7 DIMETHYL ETHER･CITRUS JUNOS SEED EXTRACT･ROSA ROXBURGHII FRUIT EXTRACT･ANGELICA ACUTILOBA ROOT EXTRACT･HYDROLYZED CONCHIOLIN PROTEIN･HYDROLYZED SILK･DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER･PERILLA OCYMOIDES LEAF EXTRACT･ISOSTEARIC ACID･BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATE･DIISOSTEARYL MALATE･DISTEARDIMONIUM HECTORITE･ALUMINUM HYDROXIDE･STEARIC ACID･TRISODIUM EDTA･POLYSILICONE-2･TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE･BHT･ALCOHOL･CITRIC ACID･SODIUM CITRATE･TRIETHOXYCAPRYLYLSILANE･DIPROPYLENE GLYCOL･TOCOPHEROL･DISODIUM STEAROYL GLUTAMATE･SODIUM METABISULFITE･THEANINE･PHENOXYETHANOL･METHYLPARABEN･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.

💲 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
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O30 1.715 g/35mL; 1.155 g/35mL 58411-0919-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O50 1.715 g/35mL; 1.155 g/35mL 58411-0921-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O60 1.715 g/35mL; 1.155 g/35mL 58411-0922-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B30 1.715 g/35mL; 1.155 g/35mL 58411-0909-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50 1.715 g/35mL; 1.155 g/35mLthis 58411-0013-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL BF10 1.715 g/35mL; 1.155 g/35mL 58411-0016-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B60 1.715 g/35mL; 1.155 g/35mL 58411-0899-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B80 1.715 g/35mL; 1.155 g/35mL 58411-0015-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL BF10 1.715 g/35mL; 1.155 g/35mL 58411-0901-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B20 1.715 g/35mL; 1.155 g/35mL 58411-0908-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL I100 1.715 g/35mL; 1.155 g/35mL 58411-0917-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B60 1.715 g/35mL; 1.155 g/35mL 58411-0014-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O10 1.715 g/35mL; 1.155 g/35mL 58411-0916-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O40 1.715 g/35mL; 1.155 g/35mL 58411-0920-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O80 1.715 g/35mL; 1.155 g/35mL 58411-0896-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B10 1.715 g/35mL; 1.155 g/35mL 58411-0906-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL I10 1.715 g/35mL; 1.155 g/35mL 58411-0915-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B40 1.715 g/35mL; 1.155 g/35mL 58411-0910-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O70 1.715 g/35mL; 1.155 g/35mL 58411-0923-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50 1.715 g/35mL; 1.155 g/35mL 58411-0898-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B70 1.715 g/35mL; 1.155 g/35mL 58411-0911-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL BF50 1.715 g/35mL; 1.155 g/35mL 58411-0913-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B100 1.715 g/35mL; 1.155 g/35mL 58411-0907-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL BF60 1.715 g/35mL; 1.155 g/35mL 58411-0914-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O20 1.715 g/35mL; 1.155 g/35mL 58411-0918-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL O90 1.715 g/35mL; 1.155 g/35mL 58411-0897-20 SHISEIDO 35 vials — — FDA listed —
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B80 1.715 g/35mL; 1.155 g/35mL 58411-0900-20 SHISEIDO 35 vials — — 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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 OCTINOXATE and TITANIUM DIOXIDE — the ingredient across all brands.

Top reported reactions

Asphyxia1
Blister1
Dyspnoea1
Eye Disorder1
Eye Pain1
Eye Swelling1
Gingival Blister1

Reporter sex

1 reports
Female · 100%
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
58411-0013-20 You're viewing this 35 VIAL in 1 CARTON (58411-013-20) / 35 mL in 1 VIAL (58411-013-70) 2021-01-01 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 58411-013-20, 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: 58411-0013-20, written without dashes as 58411001320. 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 58411-0013-20, the first segment (58411) is the labeler code FDA assigned to SHISEIDO AMERICAS CORPORATION; the middle segment (0013) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) 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 10 words ▾

Active ingredients Purpose OCTINOXATE 4.9% Sunscreen TITANIUM DIOXIDE 3.3% Sunscreen

🧪 Inactive Ingredients 54 words ▾

Inactive Ingredients WATER･DIMETHICONE･GLYCERIN･BUTYLENE GLYCOL･TRIMETHYLSILOXYSILICATE･POLYMETHYLSILSESQUIOXANE･ISODODECANE･CAPRYLYL METHICONE･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･PEG-10 DIMETHICONE･ISOPROPYL MYRISTATE･SYNTHETIC FLUORPHLOGOPITE･DIMETHICONE/PEG-10/15 CROSSPOLYMER･ERYTHRITOL･XYLITOL･BARIUM SULFATE･PYRUS CYDONIA SEED EXTRACT･TREHALOSE･ARGANIA SPINOSA KERNEL OIL･GLYCINE･PEG/PPG-14/7 DIMETHYL ETHER･CITRUS JUNOS SEED EXTRACT･ROSA ROXBURGHII FRUIT EXTRACT･ANGELICA ACUTILOBA ROOT EXTRACT･HYDROLYZED CONCHIOLIN PROTEIN･HYDROLYZED SILK･DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER･PERILLA OCYMOIDES LEAF EXTRACT･ISOSTEARIC ACID･BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATE･DIISOSTEARYL MALATE･DISTEARDIMONIUM HECTORITE･ALUMINUM HYDROXIDE･STEARIC ACID･TRISODIUM EDTA･POLYSILICONE-2･TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE･BHT･ALCOHOL･CITRIC ACID･SODIUM CITRATE･TRIETHOXYCAPRYLYLSILANE･DIPROPYLENE GLYCOL･TOCOPHEROL･DISODIUM STEAROYL GLUTAMATE･SODIUM METABISULFITE･THEANINE･PHENOXYETHANOL･METHYLPARABEN･FRAGRANCE･TITANIUM DIOXIDE･IRON OXIDES･MICA･

🎯 Purpose 10 words ▾

Active ingredients Purpose OCTINOXATE 4.9% Sunscreen TITANIUM DIOXIDE 3.3% Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58411-0012-10 · Shiseido 58411-0014-20 · 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.