Home › NDC Lookup › Ingredients › Avobenzone, Octinoxate, And Octocrylene › 58411-0856-20
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25 AVOBENZONE, OCTINOXATE, and OCTOCRYLENE 100 mg/4g; 196 mg/4g; 120 mg/4g Emulsion — NDC 58411-0856-20 package photo

cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25 AVOBENZONE, OCTINOXATE, and OCTOCRYLENE 100 mg/4g; 196 mg/4g; 120 mg/4g Emulsion

by SHISEIDO AMERICAS CORPORATION · 1 BOTTLE, GLASS in 1 BOX (58411-856-20) / 4 g in 1 BOTTLE, GLASS (58411-856-10)
NDC 58411-0856-20
🏷️ FDA NDC (as labeled) 58411-856-20 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 →

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) 58411-856-20
Product NDC 58411-856
11-digit billing NDC 58411085620
UNII G63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM
Application # M020
SPL Set ID addd9885-362c-4ce0-9a6e-759e71d8756c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-01
Route TOPICAL
Dosage form EMULSION
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 58411-856-20 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58411-0856-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerSHISEIDO AMERICAS CORPORATION
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code58411
First marketedAug 2022
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 lip emulsion that functions as a sunscreen product. It contains three UV-filtering ingredients (avobenzone, octinoxate, and octocrylene) that are commonly used together in sunscreen formulations to absorb and scatter ultraviolet radiation. The product is marketed as an over-the-counter monograph sunscreen, meaning it follows FDA's established safety and effectiveness guidelines for this category of product rather than undergoing individual approval.

Supplement & herbal interactions

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

🧪 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 FW23481S7S
    A hydrocarbon liquid derived from petroleum. It serves as a solvent and processing aid in medicines, helping dissolve or suspend active ingredients and improve how the product flows during manufacturing.
  • 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 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 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 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 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 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 UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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 5L08GE4332
    Hypotaurine is an organic compound and precursor to taurine, a naturally occurring amino acid. It may be used in formulations as a buffer or antioxidant to help stabilize the medication and maintain its effectiveness over time.
  • UNII A389O33LX6
    A plant extract from peppermint leaves used as a flavoring agent to improve taste. It may also provide a cooling or soothing sensory effect in the medicine.
  • UNII 6777U11MKT
    A silicone-based lubricant and anti-foaming agent used to reduce surface tension and prevent foam formation during manufacturing and storage of the medication.
  • 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 XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • 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 65954KGO9Q
    A plant-derived emulsifier made from phytosterols and fatty acids. It helps mix oil and water-based ingredients together and improves texture and spreadability in topical formulations.
  • 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 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 EU2PSP0G0W
    Silica dimethyl silylate is a silicon-based powder that acts as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during manufacturing and tablet compression.
  • 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 KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • UNII 3YYE6VJS0P
    A compound derived from licorice root extract combined with stearyl alcohol. It acts as an emollient and skin-conditioning agent that helps soften and smooth the product's texture while providing a protective barrier on the skin or mucous membranes.
  • 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 86H4S6K51N
    A plant extract from wild thyme used as a flavoring and aromatic ingredient in medicines. It may help mask bitter tastes and add natural flavor to oral formulations.
  • 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 7K3W1BIU6K
    A synthetic oil derived from glycerin and hexanoic acid. It acts as an emollient and lubricant in topical formulations to soften skin and improve product spreadability.
  • UNII 71503RH8KG
    Triisostearin is a waxy fat derived from stearic acid. It acts as a binder and hardening agent in tablets and capsules, helping hold ingredients together and control how quickly the medicine dissolves.
  • UNII B952ZGW1IL
    A synthetic oily compound used as an emollient and solvent in topical formulations. It helps soften the skin, improve product texture, and ensure even distribution of active ingredients.
  • 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.

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

The official label also statesTRIETHYLHEXANOIN ▪ DIISOSTEARYL MALATE ▪ HYDROGENATED POLYISOBUTENE ▪ PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE ▪ POLYETHYLENE ▪ TRIISOSTEARIN ▪ MICROCRYSTALLINE WAX ▪ BUTYLENE GLYCOL ▪ WATER ▪ GLYCERIN ▪ POLYGLYCERYL-2 DIISOSTEARATE ▪ TOCOPHERYL ACETATE ▪ ARGANIA SPINOSA KERNEL OIL ▪ SODIUM HYALURNATE ▪ CRATAEGUS MONOGYNA FLOWER EXTRACT ▪ THYMUS SERPYLLUM EXTRACT ▪ SODIUM ACETYLATED HYALURONATE ▪ AMINOETHANESULFINIC ACID ▪ TREHALOSE ▪ GLYCINE ▪ STEARYL GLYCYRRHETINATE ▪ PEG/PPG-14/7 DIMETHYL ETHER ▪ POTENTILLA ERECTA ROOT EXTRACT ▪ MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT ▪ ANGELICA ACUTILOBA ROOT EXTRACT ▪ HYDROLYZED CONCHIOLIN PROTEIN ▪ HYDROLYZED SILK ▪ SILICA DIMETHYL SILYLATE ▪ TOCOPHEROL ▪ SIMETHICONE ▪ BHT ▪ TRIMETHYLOLPROPANE TRIETHYLHEXANOATE ▪ METHICONE ▪ TETRADECENE ▪ SILICA ▪ THEANINE ▪ TIN OXIDE ▪ 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 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 PROTECTIVE LIP TREATMENT SPF 25 100 mg/4g; 196 mg/4g; 120 mg/4gthis 58411-0856-20 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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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 NDCDescription Marketing startStatus
58411-0856-20 You're viewing this 1 BOTTLE, GLASS in 1 BOX (58411-856-20) / 4 g in 1 BOTTLE, GLASS (58411-856-10) 2022-08-01 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 58411-856-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58411-0856-20, written without dashes as 58411085620. 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 58411-0856-20, the first segment (58411) is the labeler code FDA assigned to SHISEIDO AMERICAS CORPORATION; the middle segment (0856) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by SHISEIDO AMERICAS CORPORATION. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SHISEIDO AMERICAS CORPORATION is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 4 words ▾

Uses helps prevent sunburn

⏱️ Dosage and Administration 94 words ▾

Directions For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

⚠️ Warnings 56 words ▾

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

Other information protect this product in this container from excessive heat and direct sun.

🧪 Active Ingredient 12 words ▾

Active ingredients Purpose AVOBENZONE 2.5% Sunscreen OCTINOXATE 4.9% Sunscreen OCTOCRYLENE 3.0% Sunscreen

🧪 Inactive Ingredients 126 words ▾

Inactive Ingredients TRIETHYLHEXANOIN ▪ DIISOSTEARYL MALATE ▪ HYDROGENATED POLYISOBUTENE ▪ PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE ▪ POLYETHYLENE ▪ TRIISOSTEARIN ▪ MICROCRYSTALLINE WAX ▪ BUTYLENE GLYCOL ▪ WATER ▪ GLYCERIN ▪ POLYGLYCERYL-2 DIISOSTEARATE ▪ TOCOPHERYL ACETATE ▪ ARGANIA SPINOSA KERNEL OIL ▪ SODIUM HYALURNATE ▪ CRATAEGUS MONOGYNA FLOWER EXTRACT ▪ THYMUS SERPYLLUM EXTRACT ▪ SODIUM ACETYLATED HYALURONATE ▪ AMINOETHANESULFINIC ACID ▪ TREHALOSE ▪ GLYCINE ▪ STEARYL GLYCYRRHETINATE ▪ PEG/PPG-14/7 DIMETHYL ETHER ▪ POTENTILLA ERECTA ROOT EXTRACT ▪ MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT ▪ ANGELICA ACUTILOBA ROOT EXTRACT ▪ HYDROLYZED CONCHIOLIN PROTEIN ▪ HYDROLYZED SILK ▪ SILICA DIMETHYL SILYLATE ▪ TOCOPHEROL ▪ SIMETHICONE ▪ BHT ▪ TRIMETHYLOLPROPANE TRIETHYLHEXANOATE ▪ METHICONE ▪ TETRADECENE ▪ SILICA ▪ THEANINE ▪ TIN OXIDE ▪ FRAGRANCE ▪ IRON OXIDES ▪ TITANIUM DIOXIDE ▪ MICA ▪

🎯 Purpose 12 words ▾

Active ingredients Purpose AVOBENZONE 2.5% Sunscreen OCTINOXATE 4.9% Sunscreen OCTOCRYLENE 3.0% Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58411-0854-20 · SHISEIDO 58411-0857-40 · 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.