TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORAL ZINC OXIDE 13.5 g/100mL Lipstick — NDC 68577-249-01 (Billing 68577-0249-01)
by COSMAX USA · 1 TUBE in 1 CARTON / 15 mL in 1 TUBE
This is a package of TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORAL ZINC OXIDE 13.5 g/100mL Lipstick from COSMAX USA, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.
NDC 68577-0249-01
🏷️ FDA NDC (as labeled)
68577-249-01
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 68577-249-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 68577 labeler · 249 product · 01 package
- Package marketed since
- Mar 6, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6857724901 8
- FDA record last changed
- Jul 24, 2026
⚠️
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
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
68577-249-01
Product NDC
68577-249
11-digit billing NDC
68577024901
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
4d31b201-9d6a-730a-e063-6394a90a6700
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 68577-249-01 — 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 → 68577-0249-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
This is a topical lip balm sunscreen in stick form that contains zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreen products to help protect skin from ultraviolet rays. The product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen ingredients and strength rather than being approved through an individual application. This lip balm is flavored and tinted for cosmetic appeal while providing sun protection to the lips.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about ZINC OXIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68577-0249-01 You're viewing this Main listing | 1 TUBE in 1 CARTON / 15 mL in 1 TUBE | 2026-03-06 | — | Active |
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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.
Manufacturer & labeler
LabelerCOSMAX USA
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio16 products on file
More NDCs from COSMAX USA labeler code 68577
- COCO-EVE COCONUT MILK BODY SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 3 mg/100mL; 15 mg/100mL; 5 mg/100mL; 10 mg/100mL Cream NDC 68577-243-01
- COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50 Homosalate, Octocrylene, Octisalate, Avobenzone 3 mg/100mL; 15 mg/100mL; 5 mg/100mL; 10 mg/100mL Lotion NDC 68577-244-01
- NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut Zinc Oxide 13.9 g/100mg Gel NDC 68577-245-01
- PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30 ZINC OXIDE 15.98 mg/100mL Lotion NDC 68577-246-01
- MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene 3 mg/100mL; 15 mg/100mL; 5 mg/100mL; 10 mg/100mL Gel NDC 68577-247-01
- TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVE ZINC OXIDE 13.5 g/100mL Lipstick NDC 68577-248-01
- TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SAND ZINC OXIDE 13.5 g/100mL Lipstick NDC 68577-250-01
- TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLE ZINC OXIDE 13.5 g/100mL Lipstick NDC 68577-251-01
- Anew Platinum DayCream Broad Spectrum SPF 25 avobenzone, octinoxate, octisalate, oxybenzone 4 g/100mL; 7.5 g/100mL; 4.75 g/100mL; 2.85 g/100mL Cream NDC 68577-252-00
- ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONE 5 g/100mL; 8 g/100mL; 4 g/100mL; 2.85 g/100mL Cream NDC 68577-253-00
- INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN ZINC OXIDE 13.5 g/100mL Cream NDC 68577-255-00
- INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTE ZINC OXIDE 13.5 g/100mL Cream NDC 68577-256-00
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 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), FD&C Yellow 5 Lake, Menthone Glycerin Acetal, Cetearyl Ethylhexanoate, D&C Red No. 7 Calcium Lake, 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
📄 Do Not Use ▾
Do not use on damaged or broken skin
📄 When Using This Product ▾
When using this product keep out of eyes. Rinse with water to remove.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if rash occurs.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
📄 Other Information ▾
OTHER INFORMATION Other Information Protect the product in this container from excessive heat and direct sun.
📄 Questions or Comments ▾
QUESTIONS Questions? [email protected] TIRTIR.CO.KR / TIRTIR.GLOBAL
📄 Package Label / Principal Display Panel ▾
Tube Carton
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 ↗
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
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.