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PRIME Prometics LipOil SPF 35 Warm Sienna Zinc Oxide 13.5 g/100mL Oil — NDC 68577-281-00 (Billing 68577-0281-00)

by COSMAX USA, CORP · 1 TUBE in 1 CARTON / 10 mL in 1 TUBE

This is a package of PRIME Prometics LipOil SPF 35 Warm Sienna Zinc Oxide 13.5 g/100mL Oil from COSMAX USA, CORP, marketed since Oct 2025 and currently FDA-listed. It is this product's only package size.

NDC 68577-0281-00
🏷️ FDA NDC (as labeled) 68577-281-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68577-281-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68577 labeler · 281 product · 00 package
Package marketed since
Oct 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6857728100 1
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) 68577-281-00
Product NDC 68577-281
11-digit billing NDC 68577028100
UNII SOI2LOH54Z
Application # M020
SPL Set ID 56491794-712d-1306-e063-6394a90a4707
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-01
Route TOPICAL
Dosage form OIL
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 68577-281-00 — 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 → 68577-0281-00. 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.

Clinical

🧪 What is this product?

This is a topical oil sunscreen marketed as an over-the-counter monograph product. It contains zinc oxide, a mineral UV filter that functions as a physical sunblock by reflecting and scattering ultraviolet radiation from the skin. The product is formulated as an oil with an SPF 35 rating and is tinted with warm sienna color for cosmetic coverage. Sunscreens containing zinc oxide are commonly used to help reduce sun exposure to unprotected skin.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68577-0281-00 You're viewing this Main listing 1 TUBE in 1 CARTON / 10 mL in 1 TUBE 2025-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tir Tir Sun Bouncy Glow Lip Balm Spf 30 Hazy Mauve 13.5 g/100mL 68577-0248-01 COSMAX 1 tube — — FDA listed —
Tirtir Sun Bouncy Glow Lip Balm Spf 30 Soft Sand 13.5 g/100mL 68577-0250-01 COSMAX 1 tube — — FDA listed —
Tir Tir Sun Bouncy Glow Lip Balm Spf 30 Burnt Maple 13.5 g/100mL 68577-0251-01 COSMAX 1 tube — — FDA listed —
Tir Tir Sun Bouncy Glow Lip Balm Spf 30 Sunlit Coral 13.5 g/100mL 68577-0249-01 COSMAX 1 tube — — FDA listed —
Inn Beauty Sun Balm Spf30 Broad Spectrum Lip Balm - Latte 13.5 g/100mL 68577-0256-00 COSMAX 1 tube — — FDA listed —
Laura Geller X Bliss Shine - N - Shield Lip Balm Spf 15 Golden Hour 13.5 g/100mL 68577-0291-00 COSMAX 1 tube — — FDA listed —
PRIME Prometics LipOil SPF 35 Nude Rose 13.5 g/100mL 68577-0283-00 COSMAX 1 tube — — FDA listed —
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands 13.5 g/100mL 68577-0277-00 COSMAX 1 tube — — FDA listed —
PRIME Prometics LipOil SPF 35 Warm Sienna 13.5 g/100mLthis 68577-0281-00 COSMAX 1 tube — — FDA listed —
PRIME Prometics LipOil SPF 35 Nude Glow 13.5 g/100mL 68577-0285-00 COSMAX 1 tube — — FDA listed —
Laura Geller X Bliss Shine - N - Shield Lip Balm Spf 15 Going Coconuts 13.5 g/100mL 68577-0293-00 COSMAX 1 tube — — FDA listed —
PRIME Prometics LipOil SPF 35 Soft Petal 13.5 g/100mL 68577-0284-00 COSMAX 1 tube — — FDA listed —
Laura Geller X Bliss Shine - N - Shield Lip Balm Spf 15 Bliss On The Beach 13.5 g/100mL 68577-0292-00 COSMAX 1 tube — — FDA listed —
Inn Beauty Sun Balm Spf30 Broad Spectrum Lip Balm - Rosy Brown 13.5 g/100mL 68577-0255-00 COSMAX 1 tube — — FDA listed —
PRIME Prometics LipOil SPF 35 Bright Berry 13.5 g/100mL 68577-0282-00 COSMAX 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

🏛️
2025
On the market since
Oct 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.

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.

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, CORP
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio59 products on file

More NDCs from COSMAX USA, CORP labeler code 68577

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 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

USES Uses Helps prevent sunburn I used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 90 words ▾

DIRECTIONS DIRECTIONS Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating Sun Protection Measures . Spending time in the sun increases your risk of certain cancer and early aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask doctor.

⚠️ Warnings 55 words ▾

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 doctor if rash occurs Keep out of reach of children . If product is swallowed, get medical help or contact Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredients Zinc Oxide 13.5%

🧪 Inactive Ingredients 73 words ▾

INACTIVE INGREDIENTS: Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Microcrystalline Wax, SilicaDimethyl Silylate, Bis-DiglycerylPolyacyladipate-2, SorbitanOlivate, lsononyl lsononanoate, Sorbitanlsostearate, lsostearic Acid, Lecithin, Polyglyceryl-3Polyricinoleate, Polyhydroxystearic Acid, VP/Hexadecene Copolymer, IronOxides (Cl 77491), TitaniumDioxide (Cl 77891), Iron Oxides (Cl 77492), Flavor, Menthone GlycerinAcetal, Iron Oxides (Cl 77499), Dehydroacetic Acid, Red 7 Lake (Cl 15850), Rosa Canina Seed Oil, Mangifera lndica (Mango) Seed Butter, Ricinus Communis (Castor) Seed Oil, Hyaluronic Acid, Hydrogenated Castor Oil, and Tocopherol.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove

📄 Stop Use and Ask a Doctor If 8 words ▾

Stop use and ask doctor if rash occurs

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children . If product is swallowed, get medical help or contact Poison Control Center right away.

📄 Other Information 15 words ▾

OTHER INFORMATION OTHER INFORMATION Protect Product in this container from excessive heat and direct sun

📄 Package Label / Principal Display Panel 2 words ▾

Tube Carton

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, CORP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COSMAX USA, CORP 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.
← 68577-0280-00 · COSMAX 68577-0282-00 · COSMAX →
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.