lip balm SPF15( Zinc oxide) 01 8 g/100g Lipstick, 4.3 g
by Cosmuses Cosmetics (Ningbo) Co., Ltd. · 4.3 g in 1 CYLINDER (82953-074-02)
NDC 82953-0074-02
🏷️ FDA NDC (as labeled)
82953-074-02
billing pads the product segment with a zero
This package
Contains4.3 g
Pack sizes5 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
82953-074-02
Product NDC
82953-074
11-digit billing NDC
82953007402
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
5871ab1d-cf07-d737-e063-6394a90a58fe
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-08-06
Route
TOPICAL
Dosage form
LIPSTICK
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 82953-074-02 — 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 → 82953-0074-02. 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
LabelerCosmuses Cosmetics (Ningbo) Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82953
First marketedAug 2026
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 a topical lip balm containing zinc oxide, which is commonly used as a physical sunscreen ingredient. Zinc oxide functions as a broad-spectrum UV filter that sits on the skin surface to help block ultraviolet rays. With an SPF 15 rating, this OTC monograph product is a cosmetic lip protectant formulated to shield lips from sun exposure. It comes as a lipstick-style product for convenient topical application.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
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 Zinc Oxide?
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 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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UNII 6UYK2W1W1E
A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
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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.
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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.
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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.
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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 FY36J270ES
A synthetic chemical compound used as a plasticizer in film coatings. It makes tablet or capsule coatings flexible and durable so they don't crack or break during handling and 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.
15 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesTriethoxycaprylylsilane, Petrolatum, Microcrystalline Wax, Mineral Oil, Beeswax, Tridecyl Trimellitate, Ozokerite, Cocos Nucifera(Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Polyisobutene, Butyrospermum Parkii (Shea)Butter, Tocopherol, Phenoxyethanol. Fragrance, BHT
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 each | 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
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Wildara MINERAL TALLOW SUNSCREEN SPF 50 8 g/100g 87761-0005-01 | Moes | 100 g | — | — | Discontinued | — |
| Diaper Rash Cream 8 g/100g 87781-0001-01 | Foshan | 100 g | — | — | FDA listed | — |
| Badger BROAD SPECTRUM SPF 15 Lip Balm 8 g/100g 62206-1542-02 | W.S. | 4.2 g | — | — | FDA listed | — |
| ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen 8 g/100g 70793-0043-15 | Absolutely | 4.25 g | — | — | FDA listed | — |
| All Good Coconut SPF 20 Zinc Oxide Lip Balm 8 g/100g 75786-0224-01 | Elemental | 1 tube | — | — | FDA listed | — |
| Evil Goods Tallow Sunscreen Spf30 8 g/100g 87761-0008-01 | Moes | 140 g | — | — | FDA listed | — |
| lip balm SPF15( Zinc oxide) 01 8 g/100gthis 82953-0074-02 | Cosmuses | 4.3 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
🏛️
2026
On the market since
Aug 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 lip balm SPF15( Zinc oxide) 01 (this brand).
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 82953-0074-01 | 4.5 g in 1 CYLINDER (82953-074-01) | 2026-08-06 | Active |
| 82953-0074-02 You're viewing this | 4.3 g in 1 CYLINDER (82953-074-02) | 2026-08-06 | Active |
| 82953-0074-03 | 12 g in 1 CYLINDER (82953-074-03) | 2026-08-06 | Active |
| 82953-0074-04 | 7 g in 1 CYLINDER (82953-074-04) | 2026-08-06 | Active |
| 82953-0074-05 | 10 g in 1 CYLINDER (82953-074-05) | 2026-08-06 | Active |
Pack size FAQ
What quantity is in NDC 82953-0074-02?
NDC 82953-0074-02 contains 4.3 g — 4.3 g in 1 cylinder.
What is the difference between NDC 82953-0074-02 and NDC 82953-0074-01?
Both are lip balm SPF15( Zinc oxide) 01 8 g/100g Lipstick — the drug itself is identical. NDC 82953-0074-02 is the 4.3 g package, while NDC 82953-0074-01 is the 4.5 g package.
What NDC number is used to bill for this package of lip balm SPF15( Zinc oxide) 01 8 g/100g Lipstick?
Bill NDC 82953-0074-02 — the 11-digit billing format is 82953007402. 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 | ✓ 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 82953-074-02, 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: 82953-0074-02, written without dashes as 82953007402. 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 82953-0074-02, the first segment (82953) is the labeler code FDA assigned to Cosmuses Cosmetics (Ningbo) Co., Ltd.; the middle segment (0074) 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 Cosmuses Cosmetics (Ningbo) Co., Ltd.. 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 4 other package presentations of this same product, including 4.5 g (82953-0074-01), 7 g (82953-0074-04), 10 g (82953-0074-05). 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?
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 ▾
Uses Helps prevent sunburn
⏱️ Dosage and Administration ▾
Directions Apply liberally 15minutes before sun exposure Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age: Ask a doctor.
⚠️ Warnings ▾
warnings For external use only.
🧪 Active Ingredient ▾
Active ingredients Zinc oxide 8%
🧪 Inactive Ingredients ▾
Inactive ingredients Triethoxycaprylylsilane, Petrolatum, Microcrystalline Wax, Mineral Oil, Beeswax, Tridecyl Trimellitate, Ozokerite, Cocos Nucifera(Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Polyisobutene, Butyrospermum Parkii (Shea)Butter, Tocopherol, Phenoxyethanol. Fragrance, BHT
🎯 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.