cle de peau BEAUTE RADIANT FLUID FOUNDATION O70 TITANIUM DIOXIDE 2.72118 g/35mL Emulsion
by SHISEIDO AMERICAS CORPORATION · 1 BOTTLE in 1 CARTON (58411-545-10) / 35 mL in 1 BOTTLE
NDC 58411-0545-10
🏷️ FDA NDC (as labeled)
58411-545-10
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
58411-545-10
Product NDC
58411-545
11-digit billing NDC
58411054510
UNII
15FIX9V2JP
Application #
M020
SPL Set ID
b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-07-01
Route
TOPICAL
Dosage form
EMULSION
Substance
TITANIUM DIOXIDE
Why two NDCs?
The FDA registers this code as 58411-545-10 — 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 → 58411-0545-10. 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 marketedJul 2020
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 liquid makeup foundation sold as an oil-in-water emulsion. Titanium dioxide, the active ingredient, is a mineral UV filter commonly used in sunscreen and tinted cosmetic products to help protect skin from ultraviolet rays. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established guidelines for sunscreen ingredients rather than as an individually reviewed application.
Patient education
Supplement & herbal interactions
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.
💬 Questions about TITANIUM DIOXIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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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 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.
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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.
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UNII UF7620L1W6
A synthetic silicone polymer that acts as a thickener and absorbent in medicines. It helps create the right texture, improves how the product feels on skin or in the mouth, and can absorb excess moisture or oil in formulations.
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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 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.
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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 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.
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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 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 IT0296HQDC
A plant extract from hypericum erectum flowers used as a natural colorant and flavoring agent in medicines. It may provide color, taste, or mild aromatic properties to the formulation.
-
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 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 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 DG195GP57P
A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and keeps them mixed throughout the product's shelf life.
-
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 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
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 8W46YN971G
Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
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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 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.
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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.
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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.
-
UNII SOI2LOH54Z
Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.
41 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesDIMETHICONE ∙ WATER ∙ POLYMETHYLSILSESQUIOXANE ∙ GLYCERIN ∙ TRIMETHYLSILOXYSILICATE ∙ BUTYLENE GLYCOL ∙ TALC ∙ DIISOSTEARYL MALATE ∙ PEG-10 DIMETHICONE ∙ POLYGLYCERYL-2 DIISOSTEARATE ∙ BARIUM SULFATE ∙ PEG/PPG-19/19 DIMETHICONE ∙ HYDROGENATED POLYISOBUTENE ∙ DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER ∙ TREHALOSE ∙ ARGANIA SPINOSA KERNEL OIL ∙ GLYCINE ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ ROSA ROXBURGHII FRUIT EXTRACT ∙ ANGELICA ACUTILOBA ROOT EXTRACT ∙ HYDROLYZED CONCHIOLIN PROTEIN ∙ HYDROLYZED SILK ∙ PERILLA OCYMOIDES LEAF EXTRACT ∙ ALUMINUM HYDROXIDE ∙ STEARIC ACID ∙ DISTEARDIMONIUM HECTORITE ∙ BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 ∙ TRISODIUM EDTA ∙ DIMETHICONE CROSSPOLYMER ∙ DISODIUM STEAROYL GLUTAMATE ∙ ZINC OXIDE ∙ TRIETHOXYCAPRYLYLSILANE ∙ POLYSORBATE 80 ∙ ALCOHOL ∙ THEANINE ∙ TOCOPHEROL ∙ HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT ∙ SODIUM METABISULFITE ∙ PHENOXYETHANOL ∙ SODIUM DEHYDROACETATE ∙ 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 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 system | Per mL | Per 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
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
🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58411-0545-10 You're viewing this | 1 BOTTLE in 1 CARTON (58411-545-10) / 35 mL in 1 BOTTLE | 2020-07-01 | 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 58411-545-10, 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: 58411-0545-10, written without dashes as 58411054510. 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 58411-0545-10, the first segment (58411) is the labeler code FDA assigned to SHISEIDO AMERICAS CORPORATION; the middle segment (0545) 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.
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 ▾
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 ▾
Directions For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reply 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 un 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 ▾
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 ▾
Other information protect this product in this container from excessive heat and direct sun.
🧪 Active Ingredient ▾
Active Ingredients TITANIUM DIOXIDE 6.6%
🧪 Inactive Ingredients ▾
Inactive Ingredients DIMETHICONE ∙ WATER ∙ POLYMETHYLSILSESQUIOXANE ∙ GLYCERIN ∙ TRIMETHYLSILOXYSILICATE ∙ BUTYLENE GLYCOL ∙ TALC ∙ DIISOSTEARYL MALATE ∙ PEG-10 DIMETHICONE ∙ POLYGLYCERYL-2 DIISOSTEARATE ∙ BARIUM SULFATE ∙ PEG/PPG-19/19 DIMETHICONE ∙ HYDROGENATED POLYISOBUTENE ∙ DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER ∙ TREHALOSE ∙ ARGANIA SPINOSA KERNEL OIL ∙ GLYCINE ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ ROSA ROXBURGHII FRUIT EXTRACT ∙ ANGELICA ACUTILOBA ROOT EXTRACT ∙ HYDROLYZED CONCHIOLIN PROTEIN ∙ HYDROLYZED SILK ∙ PERILLA OCYMOIDES LEAF EXTRACT ∙ ALUMINUM HYDROXIDE ∙ STEARIC ACID ∙ DISTEARDIMONIUM HECTORITE ∙ BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 ∙ TRISODIUM EDTA ∙ DIMETHICONE CROSSPOLYMER ∙ DISODIUM STEAROYL GLUTAMATE ∙ ZINC OXIDE ∙ TRIETHOXYCAPRYLYLSILANE ∙ POLYSORBATE 80 ∙ ALCOHOL ∙ THEANINE ∙ TOCOPHEROL ∙ HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT ∙ SODIUM METABISULFITE ∙ PHENOXYETHANOL ∙ SODIUM DEHYDROACETATE ∙ FRAGRANCE ∙ IRON OXIDES ∙ TITANIUM DIOXIDE ∙ MICA ∙
🎯 Purpose ▾
Purpose Sunscreen
No label section mentions that — try another word, or open the full label on DailyMed below.
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.