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ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR LIP 1.147 g/3.7g; .2775 g/3.7g; .111 g/3.7g; .074 g/3.7g Lipstick, 3.7 g — NDC 10967-0676-64 package photo

ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR LIP 1.147 g/3.7g; .2775 g/3.7g; .111 g/3.7g; .074 g/3.7g Lipstick, 3.7 g

by REVLON CONSUMER PRODUCTS CORP · 3.7 g in 1 TUBE (10967-676-64)
NDC 10967-0676-64
🏷️ FDA NDC (as labeled) 10967-676-64 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 10967-676-64
Product NDC 10967-676
11-digit billing NDC 10967067664
UNII 4T6H12BN9U, 4Y5P7MUD51, 95OOS7VE0Y, G63QQF2NOX
Application # M016
SPL Set ID f3a6fe29-7af7-bfb1-e053-2a95a90a0101
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-01
Route TOPICAL
Dosage form LIPSTICK
Substance PETROLATUM; OCTINOXATE; OXYBENZONE; AVOBENZONE
Why two NDCs? The FDA registers this code as 10967-676-64 — 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 → 10967-0676-64. 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

LabelerREVLON CONSUMER PRODUCTS CORP
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code10967
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio34 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 clear lip protectant lipstick applied topically to the lips. It contains petrolatum, a moisturizing emollient that helps soften and protect the lip surface. The product also includes three UV-filtering ingredients (octinoxate, oxybenzone, and avobenzone) that are commonly used in sunscreen products to help shield lips from ultraviolet sun exposure. This is an over-the-counter monograph product, meaning it is marketed under established FDA guidelines for this category of lip care products.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • 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 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.
  • UNII 0C9AC7D6XU
    A plant-derived fat from shea nut kernels that remains after soap-making. It acts as a moisturizer, emollient, and texture enhancer in topical formulations, helping soften skin and improve product spreadability.
  • 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.
  • UNII V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • 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.
  • 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 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.
  • UNII 4CG9F9W01Q
    A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
  • UNII UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • UNII 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII YK3DC63Y5M
    A mineral compound derived from natural or synthetic sources that acts as an anti-caking agent and flow aid. It helps prevent clumping and improves the powder's ability to flow smoothly during manufacturing and tablet formation.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • 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 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • 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.
  • UNII 08MNR5YE2R
    A wax made in a laboratory to mimic natural beeswax. It's used as a coating, binder, and thickener to give medicines a smooth texture and protect them from moisture.
  • UNII Q3Z4BCH099
    A manufactured wax made from refined petroleum or plant oils. It coats tablet surfaces to control how fast the medicine dissolves and releases, and improves how the tablet feels and looks.

21 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesPolybutene, Bis-Diglyceryl Polyacyladipate-2, Polyethylene, Diisostearyl Malate, Ozokerite, Lanolin, Octyldodecyl Neopentanoate, Synthetic Fluorphlogopite, Hydrogenated Polyisobutene, Cetyl PEG/PPG-10/1 Dimethicone, Mica, Polyglyceryl-4 Isostearate, Hexyl Laurate, Synthetic Wax, BHT, Butyrospermum Parkii (Shea) Butter, Cera Alba/Beeswax/Cire D’abeille, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Parfum (Fragrance), Citral, Citronellol, Geraniol, Limonene, Linalool, Benzoic Acid. MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Iron Oxides (CI 77491), Iron Oxides (CI 77499), Red 33 Lake (CI 17200), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).]

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Elizabeth Arden Eight Hr Protectant Clear 1.147 g/3.7g; .2775 g/3.7g; .111 g/3.7g; .074 g/3.7gthis 10967-0676-64 REVLON 3.7 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 years 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.

🔬 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 ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR (this brand).

Top reported reactions

Brain Cancer Metastatic1
Seizure1

Reporter sex

1 reports
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1 0
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 NDCDescription Marketing startStatus
10967-0676-64 You're viewing this 3.7 g in 1 TUBE (10967-676-64) 2023-02-01 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 ✓ 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 10967-676-64, 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: 10967-0676-64, written without dashes as 10967067664. 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 10967-0676-64, the first segment (10967) is the labeler code FDA assigned to REVLON CONSUMER PRODUCTS CORP; the middle segment (0676) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (64) 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 REVLON CONSUMER PRODUCTS CORP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REVLON CONSUMER PRODUCTS 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.

📄 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 31 words ▾

Directions and Usage Apply liberally as often as necessary For sunscreen use: apply liberally 15 minutes before sun exposure Reapply: atleast every 2 hours Children under 6 months: ask a doctor

⏱️ Dosage and Administration 9 words ▾

Skin protectant Directions Apply liberally as often as necessary

⚠️ Warnings 86 words ▾

Warnings Skin Cancer/Skin Aging Alert: spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs or if condition lasts more than 7 days.

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

🧪 Active Ingredient 18 words ▾

ACTIVE INGREDIENTS ACTIVE INGREDIENT PURPOSE PETROLATUM 31.0% SKIN PROTECTANT AVOBENZONE 2.0% SUNSCREEN OCTINOXATE 7.5% SUNSCREEN OXYBENZONE 3.0% SUNSCREEN

🧪 Inactive Ingredients 86 words ▾

Inactive ingedients Polybutene, Bis-Diglyceryl Polyacyladipate-2, Polyethylene, Diisostearyl Malate, Ozokerite, Lanolin, Octyldodecyl Neopentanoate, Synthetic Fluorphlogopite, Hydrogenated Polyisobutene, Cetyl PEG/PPG-10/1 Dimethicone, Mica, Polyglyceryl-4 Isostearate, Hexyl Laurate, Synthetic Wax, BHT, Butyrospermum Parkii (Shea) Butter, Cera Alba/Beeswax/Cire D’abeille, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Parfum (Fragrance), Citral, Citronellol, Geraniol, Limonene, Linalool, Benzoic Acid. MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Iron Oxides (CI 77491), Iron Oxides (CI 77499), Red 33 Lake (CI 17200), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).]

🎯 Purpose 20 words ▾

Uses Helps prevent sunburn Temporarily protects and helps relieve Chapping Peeling or flaking due to minor sunburn Windburn Cracked lips

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10967-0675-16 · REVLON 10967-0678-16 · Revlon →
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.