TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SAND ZINC OXIDE 13.5 g/100mL Lipstick
by COSMAX USA · 1 TUBE in 1 CARTON (68577-250-01) / 15 mL in 1 TUBE
NDC 68577-0250-01
🏷️ FDA NDC (as labeled)
68577-250-01
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 →
⚠️
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)
68577-250-01
Product NDC
68577-250
11-digit billing NDC
68577025001
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
4d31038e-a032-3ce9-e063-6394a90a889d
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-03-06
Route
TOPICAL
Dosage form
LIPSTICK
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 68577-250-01 — 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 → 68577-0250-01. 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
LabelerCOSMAX USA
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio16 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 marketed as an over-the-counter sunscreen product under FDA's OTC monograph rules. The active ingredient zinc oxide is a mineral UV filter commonly used in sunscreen products to help protect skin from ultraviolet rays. Applied to the lips, this product functions as a sun-protective lip balm with a soft sand color and a texture described as bouncy and glossy.
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 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 6L246LAM9T
A synthetic oil derived from glycerol and adipic acid. It acts as an emulsifier and solubilizer in medicines, helping mix ingredients that don't naturally blend together and improving how the body absorbs the active drug.
-
UNII 2EH13UN8D3
A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
-
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 9M64UO4C25
A synthetic oily substance used as an emollient and texture enhancer in medicines. It helps soften formulations, improves how the medicine spreads or feels on skin, and can act as a lubricant in tablets or capsules.
-
UNII 2KAG279R6R
Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
-
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 S270N0TRQY
Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
-
UNII ZF94AP8MEY
Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
-
UNII 7YR4ZFS62E
Hydrogenated polyisobutene is a synthetic, waxy polymer derived from petroleum. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
-
UNII S4V5BS6GCX
A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
-
UNII X33R8U0062
Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
-
UNII 834K0WOS5G
A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
-
UNII 4OXD9M35X2
A natural fat extracted from mango seeds, used as an emollient and binder to soften the medicine and help hold ingredients together in creams, lotions, and solid formulations.
-
UNII 7QQ1EE6RCP
A synthetic compound made from menthone and glycerin, used in medicines as a flavoring agent and fragrance ingredient. It provides a cooling or minty taste and aroma to make medications more pleasant to take.
-
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 T7A529FB8O
A synthetic compound derived from amino acids and palmitic acid, used as a skin-conditioning agent or emollient in topical formulations to help soften and protect the skin surface.
-
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 7Q0OK5DOT4
A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
-
UNII YXH47AOU0F
A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
-
UNII II29C6E5R3
A plant-derived ingredient from the pigweed species. It acts as a natural binder and thickener to help hold the medication's components together and improve texture and consistency.
-
UNII D5340Y2I9G
Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
-
UNII MHT97MG5P8
Rosa canina seed oil is a plant-based oil extracted from wild rose seeds. It's used in medicines as an emollient and carrier, helping to soften formulations and distribute active ingredients evenly throughout the product.
-
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 01S2G2C1E4
Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
-
UNII MDL271E3GR
Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
-
UNII 3H18P0UK73
Sucrose cocoate is a natural emulsifier made from coconut oil and sugar. It helps blend water and oil-based ingredients together in formulations.
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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 KFR5QEN0N9
A synthetic plastic polymer that helps form a protective film coating on the medicine. It's used as a binder and film-former to hold the tablet or capsule together and control how quickly the drug dissolves.
-
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.
31 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive Ingredients Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Microcrystalline Wax, Silica Dimethyl Silylate, Caprylic/Capric Triglyceride, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Polyhydroxystearic Acid, Isononyl Isononanoate, Sorbitan Isostearate, Iron Oxides, VP/Hexadecene Copolymer, Isostearic Acid,Lecithin, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Menthone Glycerin Acetal, Cetearyl Ethylhexanoate, Dehydroacetic Acid, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Rosa Canina Seed Oil, Mangifera Indica (Mango) Seed Butter, Portulaca Pilosa Extract, Water, Sucrose Cocoate, Alcohol, Tocopherol, Palmitoyl Tripeptide-38.
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
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
🏛️
2026
On the market since
Mar 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 TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SAND (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
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 |
|---|---|---|---|
| 68577-0250-01 You're viewing this | 1 TUBE in 1 CARTON (68577-250-01) / 15 mL in 1 TUBE | 2026-03-06 | 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 68577-250-01, 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: 68577-0250-01, written without dashes as 68577025001. 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 68577-0250-01, the first segment (68577) is the labeler code FDA assigned to COSMAX USA; the middle segment (0250) 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 COSMAX USA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COSMAX USA 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 Uses Helps prevent sunburn
⏱️ Dosage and Administration ▾
DIRECTIONS Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Sun Protection Measures: Spending time in the sun increases you 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 a.m.- 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: 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 swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active Ingredients Zinc oxide 13.5%
🧪 Inactive Ingredients ▾
Inactive Ingredients Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Microcrystalline Wax, Silica Dimethyl Silylate, Caprylic/Capric Triglyceride, Bis-Diglyceryl Polyacyladipate-2, Sorbitan Olivate, Polyhydroxystearic Acid, Isononyl Isononanoate, Sorbitan Isostearate, Iron Oxides, VP/Hexadecene Copolymer, Isostearic Acid,Lecithin, Polyglyceryl-3 Polyricinoleate, Fragrance (Parfum), Menthone Glycerin Acetal, Cetearyl Ethylhexanoate, Dehydroacetic Acid, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, Rosa Canina Seed Oil, Mangifera Indica (Mango) Seed Butter, Portulaca Pilosa Extract, Water, Sucrose Cocoate, Alcohol, Tocopherol, Palmitoyl Tripeptide-38.
🎯 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.