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PoutScreen Lip Treatment Tiramisu Avobenzone, Octinoxate, Octocrylene 7.5 g/100mL; 10 g/100mL; 2.5 g/100mL Liquid

by NAKED SUNDAYS PTY LTD · 1 TUBE, WITH APPLICATOR in 1 CARTON (81104-605-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-605-01)
NDC 81104-0605-02
🏷️ FDA NDC (as labeled) 81104-605-02 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 81104-605-02
Product NDC 81104-605
11-digit billing NDC 81104060502
UNII 4Y5P7MUD51, G63QQF2NOX, 5A68WGF6WM
UPC 0628120900910
Application # M020
SPL Set ID 563e3ab9-4ee2-279c-e063-6294a90a7cf1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-08
Route TOPICAL
Dosage form LIQUID
Substance OCTINOXATE; OCTOCRYLENE; AVOBENZONE
Why two NDCs? The FDA registers this code as 81104-605-02 — 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 → 81104-0605-02. 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

LabelerNAKED SUNDAYS PTY LTD
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code81104
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio43 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?

PoutScreen Lip Treatment Tiramisu is a topical liquid product marketed as an over-the-counter monograph drug. It contains three active ingredients, avobenzone, octinoxate, and octocrylene, which are ultraviolet (UV) filters commonly used together in sunscreen products to help protect skin from sun exposure. This lip treatment combines these sun-protective agents in a flavored formulation intended for application to the lip area.

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 D64PM5UT4U
    A synthetic plastic-like material made from behenyl acrylate monomers. It's used as a film-former and binder to help hold tablet ingredients together and create protective coatings on medications.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 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 Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII HO4ZT5S86C
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
  • UNII 9D7IK5483F
    A synthetic oil derived from pentaerythritol and isostearic acid. It acts as an emollient and texture enhancer in topical formulations, helping create a smooth, spreadable consistency and improve skin feel.
  • UNII 1NA5AO9GH7
    A synthetic polymer derived from petroleum, polybutene is used as a binder and lubricant in solid medications to help hold ingredients together and improve the tablet or capsule's flow during manufacturing.
  • UNII MGE3733FR2
    Polyglutamic acid is a synthetic polymer made from linked amino acids. In medications, it acts as a binder to hold tablet ingredients together and may help control how quickly the drug dissolves and releases in your body.
  • UNII 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII Z4KHF2C175
    A plant-derived ingredient from tomatoes that serves as a natural colorant and flavoring agent in medications. It adds red or orange color and mild flavor to tablets and capsules.
  • UNII 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesTrimasu: Water, Polybutene (1400 MW), Isopropyl Myristate, Caprylic/Capric Triglyceride, Octyldodecanol, Squalane, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Pentaerythrityl Tetraisostearate, Ethylhexyl Methoxycrylene, Sorbitan Oleate, Stearalkonium Hectorite, Propylene Carbonate, Silica Dimethyl Silylate, Behenyl Acrylate Polymer, Polyglutamic Acid (1200 MW), Palmitoyl Hexapeptide-12, Solanum Lycopersicum (Tomato) Fruit Extract, Sucralose, Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Yellow 5 (CI 19140). Chocolate Kiss: Isopropyl Myristate, Cocos Nucifera (Coconut) Oil, Stearalkonium Hectorite, Palmitoyl Hexapeptide-12, Mica, Solanum Lycopersicum (Tomato) Fruit Extract, Polyglutamic Acid, Sucralose, Water, Silica Dimethyl Silylate, Polybutene, Ethylhexyl Methoxycrylene, Sorbitan Oleate, CI 77891, Squalane, Propylene Carbonate, Pentaerythrityl Tetraisostearate, Octyldodecanol, Behenyl Acrylate Polymer, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, CI 77491, CI 19140, CI 77499. Lemon Meringue: Isopropyl Myristate, Cocos Nucifera (Coconut) Oil, Stearalkonium Hectorite, Palmitoyl Hexapeptide-12, Mica, Solanum Lycopersicum (Tomato) Fruit Extract, Polyglutamic Acid, Sucralose, Water, Silica Dimethyl Silylate, Polybutene, Ethylhexyl Methoxycrylene, Sorbitan Oleate, CI 77891, Squalane, Propylene Carbonate, Pentaerythrityl Tetraisostearate, Octyldodecanol, Behenyl Acrylate Polymer, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, CI 77491.

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
PoutScreen Lip Treatment Love Letter 7.5 g/100mL; 10 g/100mL; 2.5 g/100mL 81104-0595-02 NAKED 1 tube — — FDA listed —
PoutScreen Lip Treatment Tiramisu 7.5 g/100mL; 10 g/100mL; 2.5 g/100mLthis 81104-0605-02 NAKED 1 tube — — FDA listed —
PoutScreen Lip Treatment Chocolate Kiss 7.5 g/100mL; 10 g/100mL; 2.5 g/100mL 81104-0604-02 NAKED 1 tube — — FDA listed —
PoutScreen Lip Treatment Lemon Meringue 7.5 g/100mL; 10 g/100mL; 2.5 g/100mL 81104-0603-02 NAKED 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
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, Octinoxate, Octocrylene — the ingredient across all brands.

Top reported reactions

Rash1
Rash Erythematous1
Rash Pruritic1
Urticaria1

Reporter sex

0 reports
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
81104-0605-02 You're viewing this 1 TUBE, WITH APPLICATOR in 1 CARTON (81104-605-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-605-01) 2026-07-08 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 — 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 81104-605-02, 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: 81104-0605-02, written without dashes as 81104060502. 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 81104-0605-02, the first segment (81104) is the labeler code FDA assigned to NAKED SUNDAYS PTY LTD; the middle segment (0605) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 NAKED SUNDAYS PTY LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NAKED SUNDAYS PTY LTD 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 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 31 words ▾

Use: • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun

⏱️ Dosage and Administration 105 words ▾

Directions: • Apply liberally and evenly 15 minutes before sun exposure. • Re-apply at least every 80 minutes or immediately after swimming, sweating or towel drying. • Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10.00AM - 2.00PM • Wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings 14 words ▾

Warnings: For external use only. • Do not use on damaged or broken skin.

🧪 Inactive Ingredients 169 words ▾

Trimasu: Water, Polybutene (1400 MW), Isopropyl Myristate, Caprylic/Capric Triglyceride, Octyldodecanol, Squalane, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Pentaerythrityl Tetraisostearate, Ethylhexyl Methoxycrylene, Sorbitan Oleate, Stearalkonium Hectorite, Propylene Carbonate, Silica Dimethyl Silylate, Behenyl Acrylate Polymer, Polyglutamic Acid (1200 MW), Palmitoyl Hexapeptide-12, Solanum Lycopersicum (Tomato) Fruit Extract, Sucralose, Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Yellow 5 (CI 19140).

Chocolate Kiss: Isopropyl Myristate, Cocos Nucifera (Coconut) Oil, Stearalkonium Hectorite, Palmitoyl Hexapeptide-12, Mica, Solanum Lycopersicum (Tomato) Fruit Extract, Polyglutamic Acid, Sucralose, Water, Silica Dimethyl Silylate, Polybutene, Ethylhexyl Methoxycrylene, Sorbitan Oleate, CI 77891, Squalane, Propylene Carbonate, Pentaerythrityl Tetraisostearate, Octyldodecanol, Behenyl Acrylate Polymer, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, CI 77491, CI 19140, CI 77499. Lemon Meringue: Isopropyl Myristate, Cocos Nucifera (Coconut) Oil, Stearalkonium Hectorite, Palmitoyl Hexapeptide-12, Mica, Solanum Lycopersicum (Tomato) Fruit Extract, Polyglutamic Acid, Sucralose, Water, Silica Dimethyl Silylate, Polybutene, Ethylhexyl Methoxycrylene, Sorbitan Oleate, CI 77891, Squalane, Propylene Carbonate, Pentaerythrityl Tetraisostearate, Octyldodecanol, Behenyl Acrylate Polymer, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, CI 77491.

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81104-0604-02 · NAKED 81104-0664-02 · Naked →
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.