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lip balm SPF15( CB222) 01 Avobenzone,Homosalate,Octocrylene,Octisalate 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g Lipstick, 4.5 g

by Cosmuses Cosmetics (Ningbo) Co., Ltd. · 4.5 g in 1 CYLINDER (82953-041-01)
NDC 82953-0041-01
🏷️ FDA NDC (as labeled) 82953-041-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 82953-041-01
Product NDC 82953-041
11-digit billing NDC 82953004101
UNII 5A68WGF6WM, V06SV4M95S, G63QQF2NOX, 4X49Y0596W
Application # M020
SPL Set ID 316416d0-52b5-6f2f-e063-6294a90a9bc1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-27
Route TOPICAL
Dosage form LIPSTICK
Substance OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE
Why two NDCs? The FDA registers this code as 82953-041-01 — 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 → 82953-0041-01. 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

LabelerCosmuses Cosmetics (Ningbo) Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82953
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio66 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 an over-the-counter lip balm formulated as a lipstick product applied topically to the lips. It contains four ultraviolet (UV) filter ingredients: avobenzone, homosalate, octisalate, and octocrylene. These chemical sunscreen agents are typically used together to absorb and scatter UV radiation from the sun, and the product is labeled SPF15 to indicate its sun protection strength. This is an OTC monograph drug, meaning it is marketed under established FDA guidelines for sunscreen products rather than through individual new drug 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 K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII Q1LS2UJO3A
    Ceresin is a purified mineral wax derived from ozocerite. It functions as a binding agent, thickener, and coating material in medicines to help hold ingredients together and provide texture or protective coating.
  • UNII 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 5XB3A63Y52
    A synthetic rubber polymer used as a glidant and lubricant in tablet and capsule formulations. It reduces friction between particles and equipment surfaces, helping medicines flow smoothly during manufacturing and preventing sticking.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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.

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

The official label also statesMicrocrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Methylparaben, Propylparaben, Tocopherol, Fragrance

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 eachPer 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
SPF15 natural lip balm 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0028-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( blueberry) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0030-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( Cocount Pina Colada) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0034-01 Cosmuses 4.5 g — — FDA listed —
Reef safe lip balm 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0049-01 Cosmuses 4.25 g — — FDA listed —
natural lip balm SPF15( Vanilla) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0036-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( Passion Fruit) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0037-01 Cosmuses 4.5 g — — FDA listed —
lip balm SPF15( CB222) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100gthis 82953-0041-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15(unflavored) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0029-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( bubble gum) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0031-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( Birthday cake) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0032-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( chocolate sundae) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0044-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( strawberry) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0039-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( tropical punch) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0040-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( Apple pie) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0035-01 Cosmuses 4.5 g — — FDA listed —
natural lip balm SPF15( Peppermint) 01 3 g/100g; 5 g/100g; 2 g/100g; 3 g/100g 82953-0038-01 Cosmuses 4.5 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Avobenzone,Homosalate,Octocrylene,Octisalate — the ingredient across all brands.

Top reported reactions

Rash14
Erythema11
Acne10
Dry Skin10
Sunburn9
Malignant Melanoma8
Condition Aggravated7

Age at onset

Child1
Adult9
Elderly11

Reporter sex

146 reports

Serious outcomes

Hospitalization22
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11 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
82953-0041-01 You're viewing this 4.5 g in 1 CYLINDER (82953-041-01) 2025-03-27 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 82953-041-01, 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: 82953-0041-01, written without dashes as 82953004101. 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 82953-0041-01, the first segment (82953) is the labeler code FDA assigned to Cosmuses Cosmetics (Ningbo) Co., Ltd.; the middle segment (0041) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Cosmuses Cosmetics (Ningbo) Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cosmuses Cosmetics (Ningbo) Co., 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Uses Helps prevent sunburn helps prevent and temporarily protect dry, chapped or windblown lips.

⏱️ Dosage and Administration 18 words ▾

Directions Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor.

⚠️ Warnings 75 words ▾

Warnings skin cancer/skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn , not cancer or early aging. For external use only Stop use and ask a doctor if rash or irritation develops and persists Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

For external use only

🧪 Active Ingredient 10 words ▾

Active ingredients Avobenzone 2% Homosalate 5% Octisalate 3% Octocrylene 3%

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients Microcrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Methylparaben, Propylparaben, Tocopherol, Fragrance

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82953-0040-01 · Cosmuses 82953-0042-01 · Cosmuses →
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.