Home › NDC Lookup › Ingredients › Avobenzone, Homosalate, Octisalate And O... › 58411-0018-40
🧴image loading
(from DailyMed)

cle de peau BEAUTE RESTORATIVE DAY SUPREME AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE 1.29125 g/50mL; 2.32425 g/50mL; 2.32425 g/50mL; 2.5825 g/50mL Cream, 50 mL

by Shiseido Americas Corporation · 1 CONTAINER in 1 CARTON (58411-018-40) / 50 mL in 1 CONTAINER
NDC 58411-0018-40
🏷️ FDA NDC (as labeled) 58411-018-40 billing pads the product segment with a zero
This package
Contains50 mL Pack sizes2 compare ↓
Also comes in: 50 mL 58411-0018-50
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) 58411-018-40
Product NDC 58411-018
11-digit billing NDC 58411001840
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID 157e52c5-f6fa-430b-bbb8-86b7c0868ad3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-01
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 58411-018-40 — 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 → 58411-0018-40. 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 marketedJul 2026
Product typeHuman Otc Drug
Portfolio361 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a topical cream sold over the counter as an OTC monograph product. It contains four active ingredients: avobenzone, homosalate, octisalate, and octocrylene, which are all ultraviolet (UV) filters commonly used in sunscreen products to help protect skin from sun exposure. The cream is typically used as a daytime moisturizer with sun protection applied to the face and exposed skin.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII I355QGZ19A
    Alpha-cellulose is a natural plant fiber used as a binder and filler in tablets and capsules. It helps hold ingredients together and adds bulk so the medicine reaches the right size and hardness.
  • 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 39YR661C4U
    A synthetic chemical compound used as a preservative in medicines to prevent bacterial and fungal growth, helping keep the product safe and effective during storage.
  • UNII BJ4GP2IFLN
    Beheneth-20 is a surfactant derived from behenic acid, a fatty acid. It helps mix oil and water-based ingredients together in formulations and can act as an emulsifier or solubilizer.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • 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 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 8HO6PVN24W
    Carnosine is a naturally occurring compound made from two amino acids. In medicines, it may serve as a buffer to help maintain the product's pH stability.
  • UNII 4VBL71TY4Y
    Safflower is a plant-derived ingredient used as a natural colorant and flavoring agent in medicines. It may also serve as a filler to add bulk to the formulation.
  • UNII QZ239038YC
    A natural extract from the cornflower plant, used as a colorant and flavoring agent to give medicines their appearance and taste.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 740M8BF6EF
    A plant-derived ingredient from coriander seeds, used primarily as a flavoring agent to improve the taste and aroma of medicines.
  • 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 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 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 CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • UNII 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 B0S90M0233
    Palm kernel oil is a natural fat extracted from palm seeds. It's used in medicines as a lubricant and binder to help tablets hold together and flow smoothly during manufacturing.
  • UNII 5QUO05548Z
    Palm oil is a natural plant-based fat extracted from palm fruit. It's used as a lubricant, binder, or coating agent to help the medicine hold together, flow smoothly during manufacturing, and sometimes improve how the body absorbs the active ingredient.
  • 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 Z9KVC81LWP
    A plant extract from geranium that acts as a natural binder and filler in the medicine. It helps hold ingredients together and add bulk to the formulation.
  • UNII 3KX376GY7L
    Glutamic acid is an amino acid used in pharmaceuticals as a buffer and pH regulator. It helps maintain the medicine's chemical stability and proper acidity level.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII O3E12ZLW5T
    A plant extract from houttuynia cordata, an herb used in traditional Asian medicine. It may serve as a natural flavoring agent or botanical additive in the formulation.
  • UNII 257THB963H
    A solid fat made from palm oil that has been chemically processed to increase stability. It functions as a binder and lubricant in tablets and capsules to help hold ingredients together and improve how the medicine flows during manufacturing.
  • UNII RMB44WO89X
    Hydroxyproline is an amino acid derived from collagen. In medications, it serves as a structural component or filler that may help provide stability and texture to the formulation.
  • UNII 4L6452S749
    Inositol is a naturally occurring sugar-like compound. It acts as an osmotic agent and sweetener in medications, helping draw water into the formulation and improve taste.
  • 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 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 4465L2WS4Y
    A plant extract from Japanese honeysuckle flowers used as a natural flavoring and fragrance ingredient in medicines. It may also help preserve the product and add pleasant taste or aroma.
  • UNII P7LJ54BP7G
    A plant-derived ingredient from nasturtium, used as a natural flavoring agent or botanical extract in medicines. It may help provide taste or serve as a carrier in liquid formulations.
  • 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 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 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 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 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 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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 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 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWater･Glycerin･Dipropylene Glycol･Dimethicone･Alcohol Denat.･Butylene Glycol･C12-15 Alkyl Benzoate･Behenyl Alcohol･Trehalose･Diphenylsiloxy Phenyl Trimethicone･Silica･Isododecane･Stearyl Alcohol･Cellulose･Carnosine･Tocopheryl Acetate･PEG/PPG-17/4 Dimethyl Ether･Phytosteryl Macadamiate･Xanthan Gum･Allantoin･Dipotassium Glycyrrhizate･Betaine･Lilium Candidum Flower Extract･Glutamic Acid･Geranium Thunbergii Flower/Leaf/Stem Extract･Centaurea Cyanus Flower Extract･Crataegus Monogyna Flower Extract･Carthamus Tinctorius (Safflower) Flower Extract･Lonicera Japonica (Honeysuckle) Flower Extract･Houttuynia Cordata Extract･Bupleurum Falcatum Root Extract･Coriandrum Sativum (Coriander) Fruit Extract･Inositol･Hydroxyproline･Nasturtium Officinale Leaf/Stem Extract･Camellia Sinensis Leaf Extract･Beheneth-20･Batyl Alcohol･Hydrogenated Palm Oil･Alcohol･Trisodium EDTA･Helianthus Annuus (Sunflower) Seed Oil･Elaeis Guineensis (Palm) Kernel Oil･Sodium Citrate･Succinoglycan･Elaeis Guineensis (Palm) Oil･Sodium Metaphosphate･BHT･Citric Acid･Tocopherol･Sodium Metabisulfite･Phenoxyethanol･Fragrance･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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 50 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 RESTORATIVE DAY SUPREME 1.29125 g/50mL; 2.32425 g/50mL; 2.32425 g/50mL; 2.5825 g/50mLthis 58411-0018-40 Shiseido 50 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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, HOMOSALATE, OCTISALATE, and OCTOCRYLENE — the ingredient across all brands.

Top reported reactions

Skin Cancer58
Basal Cell Carcinoma21
Neoplasm Malignant21
Rash21
Malignant Melanoma19
Product Lot Number Issue12
Recalled Product Administered11

Age at onset

Infant1
Child2
Adolescent2
Adult42
Elderly19

Reporter sex

259 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization15
Disabling8
Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 193 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
58411-0018-40 You're viewing this 1 CONTAINER in 1 CARTON (58411-018-40) / 50 mL in 1 CONTAINER 2026-07-01 Active
58411-0018-50 1 JAR in 1 CARTON (58411-018-50) / 50 mL in 1 JAR 2026-07-01 Active

Pack size FAQ

What quantity is in NDC 58411-0018-40?
NDC 58411-0018-40 contains 50 mL — 1 container in 1 carton / 50 ml in 1 container.
What NDC number is used to bill for this package of cle de peau BEAUTE RESTORATIVE DAY SUPREME AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE 1.29125 g/50mL; 2.32425 g/50mL; 2.32425 g/50mL; 2.5825 g/50mL Cream?
Bill NDC 58411-0018-40 — the 11-digit billing format is 58411001840. 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 — Not published for this NDC No photo available yet for this listing.
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 58411-018-40, 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: 58411-0018-40, written without dashes as 58411001840. 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 58411-0018-40, the first segment (58411) is the labeler code FDA assigned to Shiseido Americas Corporation; the middle segment (0018) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 jar (58411-0018-50). 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 29 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 95 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 Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: 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 sun

🧪 Inactive Ingredients 72 words ▾

Water･Glycerin･Dipropylene Glycol･Dimethicone･Alcohol Denat.･Butylene Glycol･C12-15 Alkyl Benzoate･Behenyl Alcohol･Trehalose･Diphenylsiloxy Phenyl Trimethicone･Silica･Isododecane･Stearyl Alcohol･Cellulose･Carnosine･Tocopheryl Acetate･PEG/PPG-17/4 Dimethyl Ether･Phytosteryl Macadamiate･Xanthan Gum･Allantoin･Dipotassium Glycyrrhizate･Betaine･Lilium Candidum Flower Extract･Glutamic Acid･Geranium Thunbergii Flower/Leaf/Stem Extract･Centaurea Cyanus Flower Extract･Crataegus Monogyna Flower Extract･Carthamus Tinctorius (Safflower) Flower Extract･Lonicera Japonica (Honeysuckle) Flower Extract･Houttuynia Cordata Extract･Bupleurum Falcatum Root Extract･Coriandrum Sativum (Coriander) Fruit Extract･Inositol･Hydroxyproline･Nasturtium Officinale Leaf/Stem Extract･Camellia Sinensis Leaf Extract･Beheneth-20･Batyl Alcohol･Hydrogenated Palm Oil･Alcohol･Trisodium EDTA･Helianthus Annuus (Sunflower) Seed Oil･Elaeis Guineensis (Palm) Kernel Oil･Sodium Citrate･Succinoglycan･Elaeis Guineensis (Palm) Oil･Sodium Metaphosphate･BHT･Citric Acid･Tocopherol･Sodium Metabisulfite･Phenoxyethanol･Fragrance･Iron Oxides･

🎯 Purpose 15 words ▾

Active Ingredients Purpose Avobenzone 2.5% Sunscreen Homosalate 4.5% Sunscreen Octisalate 4.5% 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 ↗
← 58411-0017-50 · Shiseido 58411-0020-60 · Shiseido →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.