cle de peau BEAUTE RADIANT FOUNDATION N BF60 octinoxate and titanium dioxide 1.07 g/21mL; .3 g/21mL Emulsion — NDC 58411-0654-60 package photo

cle de peau BEAUTE RADIANT FOUNDATION N BF60 octinoxate and titanium dioxide 1.07 g/21mL; .3 g/21mL Emulsion

by SHISEIDO AMERICAS CORPORATION · 1 TUBE in 1 CARTON (58411-654-60) / 21 mL in 1 TUBE
NDC 58411-0654-60
🏷️ FDA NDC (as labeled) 58411-654-60 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 →

🆔 Identity & classification

FDA NDC (as labeled) 58411-654-60
Product NDC 58411-654
11-digit billing NDC 58411065460
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M020
SPL Set ID 05ffb157-5e28-4e94-866d-9e3371480d84
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-05-01
Route TOPICAL
Dosage form EMULSION
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 58411-654-60 — 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 → 58411-0654-60. 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 marketedMay 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?

This is a topical emulsion foundation sold as an over-the-counter sunscreen product under FDA's OTC monograph rules. The two active ingredients, octinoxate and titanium dioxide, are UV filters commonly used together in sunscreen formulations to help protect skin from ultraviolet radiation. Octinoxate is an organic UV absorber, while titanium dioxide is an inorganic reflective agent. This product is meant to be applied to the face as a cosmetic foundation with built-in sun protection.

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 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 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 H390488X0A
    Behenic acid is a waxy substance derived from plant oils. It functions as a lubricant and binder in tablets and capsules, helping reduce friction during manufacturing and holding ingredients together.
  • 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 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 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • 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 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 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • 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 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 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 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 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 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 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 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 U076Q6Q621
    Polyethylene glycol 1000 is a synthetic compound made from ethylene oxide. It serves as a solvent, lubricant, and humectant in medicines, helping dissolve active ingredients and improve how the product flows and feels.
  • UNII 1212Z7S33A
    PEG-32 is a synthetic polymer derived from ethylene oxide. It acts as a humectant and solvent in medications, helping to dissolve or suspend active ingredients and maintain moisture in solid dosage forms.
  • UNII 5655G9Y8AQ
    A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.
  • 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 BI896CKT6B
    A plant extract from the tormentil root, used as a natural astringent and binding agent. It helps hold the medicine together and may provide texture or consistency to the formulation.
  • UNII 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 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 VU97D01BF9
    A waxy emulsifier derived from sorbitol, a natural sugar alcohol. It helps blend oil and water-based ingredients together and improves the texture and stability of the medicine.
  • 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 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 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 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.

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

The official label also statesWATER∙DIMETHICONE∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙DIPROPYLENE GLYCOL∙GLYCERIN∙BUTYLENE GLYCOL∙PEG-10 DIMETHICONE∙PEG-20∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙PEG-6∙PEG-32∙DISTEARDIMONIUM HECTORITE∙BARIUM SULFATE∙DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙HYDROGENATED POLYISOBUTENE∙TREHALOSE∙ARGANIA SPINOSA KERNEL OIL∙GLYCINE∙PEG/PPG-14/7 DIMETHYL ETHER∙POTENTILLA ERECTA ROOT EXTRACT∙TRIMETHYLSILOXYSILICATE∙ROSA ROXBURGHII FRUIT EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙PERILLA OCYMOIDES LEAF EXTRACT∙SORBITAN SESQUIISOSTEARATE∙DIISOSTEARYL MALATE∙BEHENIC ACID∙SYNTHETIC FLUORPHLOGOPITE∙ALUMINUM HYDROXIDE∙DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER∙TRISODIUM EDTA∙TALC∙TRIETHOXYCAPRYLYLSILANE∙POLYSILICONE-2∙STEARIC ACID∙TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE∙HYDROGEN DIMETHICONE∙BHT∙SILICA∙THEANINE∙TOCOPHEROL∙POLYMETHYLSILSESQUIOXANE∙METHYLPARABEN∙ETHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙TITANIUM DIOXIDE∙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 DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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 FOUNDATION N BF60 1.07 g/21mL; .3 g/21mLthis 58411-0654-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N I10 1.07 g/21mL; .3 g/21mL 58411-0631-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N O10 1.07 g/21mL; .3 g/21mL 58411-0632-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N O40 1.07 g/21mL; .3 g/21mL 58411-0634-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N O50 1.07 g/21mL; .3 g/21mL 58411-0642-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N O70 1.07 g/21mL; .3 g/21mL 58411-0644-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N B40 1.07 g/21mL; .3 g/21mL 58411-0635-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N BF50 1.07 g/21mL; .3 g/21mL 58411-0653-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N O20 1.07 g/21mL; .3 g/21mL 58411-0655-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N B90 1.07 g/21mL; .3 g/21mL 58411-0640-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N B30 1.07 g/21mL; .3 g/21mL 58411-0650-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N BF10 1.07 g/21mL; .3 g/21mL 58411-0652-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N B60 1.07 g/21mL; .3 g/21mL 58411-0637-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N B50 1.07 g/21mL; .3 g/21mL 58411-0636-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N B80 1.07 g/21mL; .3 g/21mL 58411-0639-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N O80 1.07 g/21mL; .3 g/21mL 58411-0645-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N B70 1.07 g/21mL; .3 g/21mL 58411-0638-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N O30 1.07 g/21mL; .3 g/21mL 58411-0641-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N B100 1.07 g/21mL; .3 g/21mL 58411-0651-60 SHISEIDO 1 tube FDA listed
cle de peau BEAUTE RADIANT FOUNDATION N O60 1.07 g/21mL; .3 g/21mL 58411-0643-60 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

🏛️
2021
On the market since
May 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
58411-0654-60 You're viewing this 1 TUBE in 1 CARTON (58411-654-60) / 21 mL in 1 TUBE 2021-05-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ 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 58411-654-60, 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: 58411-0654-60, written without dashes as 58411065460. 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 58411-0654-60, the first segment (58411) is the labeler code FDA assigned to SHISEIDO AMERICAS CORPORATION; the middle segment (0654) 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 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 two 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 4.4% Sunscreen TITANIUM DIOXIDE 1.2% Sunscreen

🧪 Inactive Ingredients 55 words

Inactive Ingredients WATER∙DIMETHICONE∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙DIPROPYLENE GLYCOL∙GLYCERIN∙BUTYLENE GLYCOL∙PEG-10 DIMETHICONE∙PEG-20∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙PEG-6∙PEG-32∙DISTEARDIMONIUM HECTORITE∙BARIUM SULFATE∙DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙HYDROGENATED POLYISOBUTENE∙TREHALOSE∙ARGANIA SPINOSA KERNEL OIL∙GLYCINE∙PEG/PPG-14/7 DIMETHYL ETHER∙POTENTILLA ERECTA ROOT EXTRACT∙TRIMETHYLSILOXYSILICATE∙ROSA ROXBURGHII FRUIT EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙PERILLA OCYMOIDES LEAF EXTRACT∙SORBITAN SESQUIISOSTEARATE∙DIISOSTEARYL MALATE∙BEHENIC ACID∙SYNTHETIC FLUORPHLOGOPITE∙ALUMINUM HYDROXIDE∙DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER∙TRISODIUM EDTA∙TALC∙TRIETHOXYCAPRYLYLSILANE∙POLYSILICONE-2∙STEARIC ACID∙TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE∙HYDROGEN DIMETHICONE∙BHT∙SILICA∙THEANINE∙TOCOPHEROL∙POLYMETHYLSILSESQUIOXANE∙METHYLPARABEN∙ETHYLPARABEN∙FRAGRANCE∙IRON OXIDES∙TITANIUM DIOXIDE∙MICA

🎯 Purpose 10 words

Active ingredients Purpose OCTINOXATE 4.4% Sunscreen TITANIUM DIOXIDE 1.2% Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.