Home › NDC Lookup › Ingredients › Avobenzone, Octinoxate, Octocrylene › 58411-0953-10
cle de peau BEAUTE Protective Day Avobenzone, Octinoxate, Octocrylene 3.25 g/125mL; 6.38 g/125mL; 6.51 g/125mL Emulsion — NDC 58411-0953-10 package photo

cle de peau BEAUTE Protective Day Avobenzone, Octinoxate, Octocrylene 3.25 g/125mL; 6.38 g/125mL; 6.51 g/125mL Emulsion

by Shiseido Americas Corporation · 1 BOTTLE, GLASS in 1 BOX (58411-953-10) / 125 mL in 1 BOTTLE, GLASS
NDC 58411-0953-10
🏷️ FDA NDC (as labeled) 58411-953-10 billing pads the product segment with a zero
This package
Contains125 mL in 1 bottle, glass Pack sizes3 compare ↓
Also comes in: 12 mL 58411-0953-11 5 mL 58411-0953-12
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) 58411-953-10
Product NDC 58411-953
11-digit billing NDC 58411095310
UNII G63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM
Application # M020
SPL Set ID dea8e4c1-6a9c-44c6-abc8-6cdd50f35f49
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-02
Route TOPICAL
Dosage form EMULSION
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 58411-953-10 — 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 → 58411-0953-10. 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 marketedFeb 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 emulsion marketed as an over-the-counter sunscreen under FDA's OTC monograph rules. It contains three active ingredients (avobenzone, octinoxate, and octocrylene) that function as ultraviolet light filters, commonly used in sunscreen products to help absorb or reflect UVA and UVB rays from the sun. The emulsion formulation allows the protective agents to be applied evenly to the skin surface.

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 pink
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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 313S43DM16
    A nonionic surfactant derived from behenic acid (a fatty acid). It helps dissolve, suspend, or mix oil and water components in the formula, and may improve how the medicine is absorbed.
  • UNII X04E310LUY
    Bupleurum falcatum root is a plant extract used as a natural flavoring and botanical ingredient. It may help mask bitter tastes and add herbal characteristics to the medicine.
  • 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII LED42LZG6O
    C13-16 isoparaffin is a mixture of refined mineral oils derived from petroleum. It acts as a solvent and emollient in topical formulations, helping dissolve active ingredients and soften the skin.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII NT52AMP29J
    A plant extract from hawthorn flowers used as a natural flavoring agent and coloring ingredient in medicines. It may also help bind ingredients together in tablet or capsule formulations.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII 3YC120743U
    Diglycerin is a humectant and solvent derived from glycerin. It helps retain moisture in the formulation and improves texture and stability in liquid or semi-solid medicines.
  • 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 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 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 Y5967KO1JH
    A concentrated oil extracted from ginkgo biloba leaves. It's used in medicines as a flavoring agent and to deliver the plant's active compounds in liquid or semi-solid formulations.
  • 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 525G687TQW
    A natural plant extract from hibiscus seeds, used as a thickener and binder in medicines. It helps create the right texture and holds ingredients together in the formulation.
  • UNII 2SFZ1X3QA9
    A plant extract from hydrangea serrata leaves used in supplements and medicines. It may serve as a flavor, botanical additive, or functional ingredient in formulations.
  • UNII 4YI0729529
    A synthetic oil made from plant-derived hydrocarbons that has been chemically saturated. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and improve tablet handling.
  • UNII COV655U2CJ
    A plant extract from white lily flowers used as a fragrance, flavor, or botanical ingredient in medicines. It may help mask unpleasant tastes or add natural scent to the product.
  • 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 FD2FMC53M1
    A plant extract from the spiny restharrow root, traditionally used in herbal preparations. In medicines, it functions as a natural flavoring agent or botanical additive to support formulation characteristics.
  • UNII SST9XCL51M
    Oryzanol is a plant compound extracted from rice bran oil. It's used in medicines as an antioxidant and emollient to help stabilize the formula and improve texture.
  • UNII CUQ3A77YXI
    Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
  • 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 8CU46UJ38C
    A waxy compound made from polyethylene glycol and stearic acid. It acts as an emulsifier to blend oil and water-based ingredients, and helps form a smooth, consistent texture in the medication.
  • UNII 4ET18WJG5K
    A synthetic liquid polymer made from ethylene glycol and propylene glycol components. Used in medications as a solvent to dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from 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 233VSF903M
    A plant-derived oil compound used as an emollient and skin-conditioning agent. It helps soften the product texture and improve how the medicine spreads on or absorbs into the skin.
  • 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 5G3H7U4Y7F
    A synthetic compound that belongs to the salicylate family of chemicals. It serves as a preservative and antimicrobial agent in topical formulations to help prevent bacterial and fungal growth and extend product shelf life.
  • UNII 3TNW8D08V3
    Rosa canina fruit, also called rosehip, is a natural plant extract used in medicines as a filler and to add nutritional content. It may also help with texture or act as a mild flavoring agent in 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 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 WN66R7GL93
    A modified form of hyaluronic acid, a naturally occurring substance that holds water. Used as a thickener, lubricant, and moisture-retaining agent in formulations, especially in topical or injectable products.
  • UNII 532IUT7IRV
    A salt derived from phosphoric acid, sodium metaphosphate acts as a buffer and sequestrant in medicines. It helps stabilize the product and prevent unwanted chemical reactions during storage.
  • 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 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 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 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 728JDI7G4M
    A natural extract from the fruit rind of the Sichuan pepper plant. It serves as a flavoring agent to improve taste and may provide aroma to the medicine.

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

The official label also statesWATER･DIPROPYLENE GLYCOL･BUTYLENE GLYCOL･ALCOHOL DENAT.･GLYCERIN･DIISOPROPYL SEBACATE･C12-15 ALKYL BENZOATE･SILICA･DIGLYCERIN･DIMETHICONE･TREHALOSE･POTASSIUM METHOXYSALICYLATE･PHYTOSTERYL MACADAMIATE･PEG-6･PEG-32･ORYZANOL･TOCOPHERYL ACETATE･PEG/PPG-17/4 DIMETHYL ETHER･TRIMETHYLSILOXYSILICATE･GINKGO BILOBA LEAF EXTRACT･CRATAEGUS MONOGYNA FLOWER EXTRACT･PANAX GINSENG ROOT EXTRACT･ONONIS SPINOSA ROOT EXTRACT･HYDRANGEA SERRATA LEAF EXTRACT･ROSA CANINA FRUIT EXTRACT･SAXIFRAGA SARMENTOSA EXTRACT･ZANTHOXYLUM PIPERITUM PEEL EXTRACT･HIBISCUS ESCULENTUS FRUIT EXTRACT･SODIUM ACETYLATED HYALURONATE･ROSA ROXBURGHII FRUIT EXTRACT･LILIUM CANDIDUM FLOWER EXTRACT･BUPLEURUM FALCATUM ROOT EXTRACT･PETROLATUM･HYDROGENATED POLYDECENE･PEG-10 PHYTOSTEROL･SUCCINOGLYCAN･MICA･PEG-6 DISTEARATE･BEHENETH-10･CARBOMER･ALCOHOL･PEG/PPG-19/19 DIMETHICONE･STEARIC ACID･DEXTRIN PALMITATE/ETHYLHEXANOATE･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･CERAMIDE NP･POTASSIUM HYDROXIDE･C13-16 ISOPARAFFIN･BHT･SODIUM METAPHOSPHATE･DISODIUM EDTA･C10-13 ISOPARAFFIN･SODIUM METABISULFITE･TOCOPHEROL･PHENOXYETHANOL･FRAGRANCE･TITANIUM DIOXIDE･IRON OXIDES･RED 33･YELLOW 5･

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.
Try another pack size: 12 mL 5 mL
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 Protective Day 3.25 g/125mL; 6.38 g/125mL; 6.51 g/125mLthis 58411-0953-10 Shiseido 1 bottle — — 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
Feb 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.

🔬 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 Avobenzone, Octinoxate, Octocrylene — the ingredient across all brands.

Top reported reactions

Rash1
Rash Erythematous1
Rash Pruritic1
Urticaria1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1 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
58411-0953-10 You're viewing this 1 BOTTLE, GLASS in 1 BOX (58411-953-10) / 125 mL in 1 BOTTLE, GLASS 2025-12-11 Active
58411-0953-11 1 BOTTLE, PLASTIC in 1 BOX (58411-953-11) / 12 mL in 1 BOTTLE, PLASTIC 2025-02-02 Active
58411-0953-12 1 BOTTLE, PLASTIC in 1 BOX (58411-953-12) / 5 mL in 1 BOTTLE, PLASTIC 2025-02-02 Active

Pack size FAQ

What quantity is in NDC 58411-0953-10?
NDC 58411-0953-10 is listed by the FDA — 1 bottle, glass in 1 box / 125 ml in 1 bottle, glass.
What NDC number is used to bill for this package of cle de peau BEAUTE Protective Day Avobenzone, Octinoxate, Octocrylene 3.25 g/125mL; 6.38 g/125mL; 6.51 g/125mL Emulsion?
Bill NDC 58411-0953-10 — the 11-digit billing format is 58411095310. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 58411-953-10, 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: 58411-0953-10, written without dashes as 58411095310. 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 58411-0953-10, the first segment (58411) is the labeler code FDA assigned to Shiseido Americas Corporation; the middle segment (0953) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (58411-0953-11), 1 bottle (58411-0953-12). Each has its own NDC and its own page — see the package list near the top of this page.
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 28 words ▾

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 ▾

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 5 words ▾

Warnings For external use only

📦 Storage and Handling 14 words ▾

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

🧪 Inactive Ingredients 69 words ▾

WATER･DIPROPYLENE GLYCOL･BUTYLENE GLYCOL･ALCOHOL DENAT.･GLYCERIN･DIISOPROPYL SEBACATE･C12-15 ALKYL BENZOATE･SILICA･DIGLYCERIN･DIMETHICONE･TREHALOSE･POTASSIUM METHOXYSALICYLATE･PHYTOSTERYL MACADAMIATE･PEG-6･PEG-32･ORYZANOL･TOCOPHERYL ACETATE･PEG/PPG-17/4 DIMETHYL ETHER･TRIMETHYLSILOXYSILICATE･GINKGO BILOBA LEAF EXTRACT･CRATAEGUS MONOGYNA FLOWER EXTRACT･PANAX GINSENG ROOT EXTRACT･ONONIS SPINOSA ROOT EXTRACT･HYDRANGEA SERRATA LEAF EXTRACT･ROSA CANINA FRUIT EXTRACT･SAXIFRAGA SARMENTOSA EXTRACT･ZANTHOXYLUM PIPERITUM PEEL EXTRACT･HIBISCUS ESCULENTUS FRUIT EXTRACT･SODIUM ACETYLATED HYALURONATE･ROSA ROXBURGHII FRUIT EXTRACT･LILIUM CANDIDUM FLOWER EXTRACT･BUPLEURUM FALCATUM ROOT EXTRACT･PETROLATUM･HYDROGENATED POLYDECENE･PEG-10 PHYTOSTEROL･SUCCINOGLYCAN･MICA･PEG-6 DISTEARATE･BEHENETH-10･CARBOMER･ALCOHOL･PEG/PPG-19/19 DIMETHICONE･STEARIC ACID･DEXTRIN PALMITATE/ETHYLHEXANOATE･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･CERAMIDE NP･POTASSIUM HYDROXIDE･C13-16 ISOPARAFFIN･BHT･SODIUM METAPHOSPHATE･DISODIUM EDTA･C10-13 ISOPARAFFIN･SODIUM METABISULFITE･TOCOPHEROL･PHENOXYETHANOL･FRAGRANCE･TITANIUM DIOXIDE･IRON OXIDES･RED 33･YELLOW 5･

🎯 Purpose 12 words ▾

Drug Facts Purpose Avobenzone 2.5% Sunscreen Octinoxate 4.9% Sunscreen Octocrylene 5.0% Sunscreen

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