Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands ZINC OXIDE 13.5 g/100mL Lipstick — NDC 68577-277-00 (Billing 68577-0277-00)
by COSMAX USA, CORP · 1 TUBE in 1 CARTON / 16 mL in 1 TUBE
This is a package of LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands ZINC OXIDE 13.5 g/100mL Lipstick from COSMAX USA, CORP, marketed since Oct 2025 and currently FDA-listed. It is this product's only package size.
NDC 68577-0277-00
🏷️ FDA NDC (as labeled)
68577-277-00
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 68577-277-00 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 68577 labeler · 277 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 6857727700 4
- 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)
68577-277-00
Product NDC
68577-277
11-digit billing NDC
68577027700
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
5648da76-5a67-605a-e063-6294a90a4e3b
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
LIPSTICK
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 68577-277-00 — 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 → 68577-0277-00. 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.
- 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 lipstick marketed as an OTC monograph drug under FDA's established rules for sunscreen products. The active ingredient, zinc oxide at 13.5%, functions as a physical (mineral) sunscreen filter. Zinc oxide is typically used to reflect and scatter ultraviolet rays from the sun and is commonly found in broad-spectrum sun protection products applied to the lips and face.
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 |
|---|---|---|---|---|
| 68577-0277-00 You're viewing this Main listing | 1 TUBE in 1 CARTON / 16 mL in 1 TUBE | 2025-10-01 | — | 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
🏛️
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.
- 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
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 ECW0LZ41X8
A synthetic red dye used to color tablets and capsules. It helps make medicines visually distinctive so patients can easily identify their medication.
-
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 JQ6BLH9FR7
FD&C Yellow No. 5 Aluminum Lake is a bright yellow colorant made by combining a synthetic dye with aluminum and other salts. It colors tablets and capsules to help identify the medication and make it visually distinctive.
-
UNII G7036X8B5H
A dark iron compound that gives medicine its color. Used as a colorant in tablets and capsules to help identify the medication and make it visually distinctive.
-
UNII 7D1YQ9Y5EZ
Hydrogenated polybutene is a thick, wax-like ingredient made by chemically processing petroleum. It acts as a binder and lubricant, helping hold tablet ingredients together and allowing pills to slide smoothly during manufacturing and packaging.
-
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 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 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 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 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
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.
21 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesINACTIVE INGREDIENTS: DIISOSTEARYL MALATE, SILICA DIMETHYL SILYLATE, POLYBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LECITHIN, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, HYDROGENATED POLYISOBUTENE, BUTYLOCTYL SALICYLATE, MICROCRYSTALLINE WAX, BIS-DIGLYCERYL POLYACYLADIPATE-2, SORBITAN OLIVATE, ISONONYL ISONONANOATE, SORBITAN ISOSTEARATE, VP/HEXADECENE COPOLYMER, MENTHONE GLYCERIN ACETAL, DEHYDROACETIC ACID, FLAVOR, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), YELLOW 5 LAKE (CI 19140), RED 7 LAKE (CI 15850).
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.- 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, 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
- VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRAL ZINC OXIDE 13.1 g/100mL Lotion NDC 68577-271-00
- VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRM ZINC OXIDE 13.1 g/100mL Lotion NDC 68577-272-00
- VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOL ZINC OXIDE 13.1 g/100mL Lotion NDC 68577-273-00
- VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRM ZINC OXIDE 13.1 g/100mL Lotion NDC 68577-274-00
- VERSED MULTI SERUM SKIN TINT SPF 40 DEEP NEUTRAL ZINC OXIDE 13.1 g/100mL Lotion NDC 68577-275-00
- VERSED MULTI SERUM SKIN TINT SPF 40 DEEP COOL ZINC OXIDE 13.1 g/100mL Lotion NDC 68577-276-00
- Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45 Homosalate, Octocrylene, Octisalate, Avobenzone 15 g/100mL; 10 g/100mL; 5 g/100mL; 3 g/100mL Oil NDC 68577-278-00
- The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud Zinc Oxide 22.95 g/100mL Lipstick NDC 68577-279-00
- The Mineral Lip One SPF 45 Nourishing Lip Tint Berry Balmy Zinc Oxide 22.95 g/100mL Lipstick NDC 68577-280-00
- PRIME Prometics LipOil SPF 35 Warm Sienna Zinc Oxide 13.5 g/100mL Oil NDC 68577-281-00
- PRIME Prometics LipOil SPF 35 Bright Berry Zinc Oxide 13.5 g/100mL Oil NDC 68577-282-00
- PRIME Prometics LipOil SPF 35 Nude Rose Zinc Oxide 13.5 g/100mL Oil NDC 68577-283-00
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
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
USES Uses: Helps prevent sunburn
⏱️ Dosage and Administration ▾
DIRECTIONS Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying After eating or drinking As often as necessary
⚠️ 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 Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if rash occurs.
🧪 Active Ingredient ▾
Active ingredient Zinc Oxide 13.5%
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS : DIISOSTEARYL MALATE, SILICA DIMETHYL SILYLATE, POLYBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LECITHIN, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, HYDROGENATED POLYISOBUTENE, BUTYLOCTYL SALICYLATE, MICROCRYSTALLINE WAX, BIS-DIGLYCERYL POLYACYLADIPATE-2, SORBITAN OLIVATE, ISONONYL ISONONANOATE, SORBITAN ISOSTEARATE, VP/HEXADECENE COPOLYMER, MENTHONE GLYCERIN ACETAL, DEHYDROACETIC ACID, FLAVOR, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), YELLOW 5 LAKE (CI 19140), RED 7 LAKE (CI 15850).
🎯 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.
📄 Package Label / Principal Display Panel ▾
Laura Geller Shine-n-Shield Lip Balm SPF 15 0.54 fl.oz./16ML 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 ↗
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 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands (this brand).
Top reported reactions
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.
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 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.
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.