Home › NDC Lookup › Ingredients › Avobenzone, Dimethicone, Octinoxate, Oct... › 71564-0001-42
OKeeffes Lip Repair Avobenzone, Dimethicone, Octinoxate, Octocrylene 2.5 g/100g; 17.5 g/100g; 6 g/100g; 2 g/100g Stick, 1 cylinder — NDC 71564-0001-42 package photo

OKeeffes Lip Repair Avobenzone, Dimethicone, Octinoxate, Octocrylene 2.5 g/100g; 17.5 g/100g; 6 g/100g; 2 g/100g Stick, 1 cylinder

by The Gorilla Glue Company/O'Keeffe's Company · 1 CYLINDER in 1 BLISTER PACK (71564-001-42) / 4.2 g in 1 CYLINDER
NDC 71564-0001-42
🏷️ FDA NDC (as labeled) 71564-001-42 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 →

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) 71564-001-42
Product NDC 71564-001
11-digit billing NDC 71564000142
UNII G63QQF2NOX, 92RU3N3Y1O, 4Y5P7MUD51, 5A68WGF6WM
UPC 0371564000073
Application # M020
SPL Set ID 6805b3e9-77cb-bfee-e053-2991aa0a8d98
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-22
Route TOPICAL
Dosage form STICK
Substance AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 71564-001-42 — 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 → 71564-0001-42. 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

LabelerThe Gorilla Glue Company/O'Keeffe's Company
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code71564
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio5 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?

O'Keeffe's Lip Repair is a topical stick product marketed as an over-the-counter monograph drug. It contains two ultraviolet (UV) sunscreen filters, avobenzone and octinoxate, along with octocrylene, which is commonly used in sunscreen formulations to stabilize UV filters. Dimethicone, a silicone-based ingredient, is typically used to create a protective, water-resistant barrier on the lips. Together, these ingredients are intended to help protect and condition the lip area.

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 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII P0TX083987
    A synthetic oil made from hydrogenated plant-derived hydrocarbons, used as a lubricant and glidant to help powder particles flow smoothly during tablet or capsule manufacturing and to prevent sticking.
  • 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 UZH29XGA8G
    Lime oil is a natural fragrant liquid extracted from lime fruit peel. It's used in medicines as a flavoring agent to mask bitter or unpleasant tastes, making the medicine more pleasant to take.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 587WKM3S9Q
    A synthetic polymer made from trimethylpentanediol, adipic acid, and glycerin. It acts as a thickener and stabilizer in formulations, helping maintain consistent texture and prevent ingredient separation.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesInactive ingredients Beeswax, Petrolatum, Hydrogenated Poly (C6-14 Olefin), Phenyl Trimethicone, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Butyrospermum Parkii (Shea) Butter, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Flavor, Polysilicone-11, Hydrogenated Polyisobutane, Hydrogenated Vegetable Oil, Ethylene/Propylene/Styrene Copolymer, Sodium Saccharin, Citrus Aurantifolia (Lime) Peel Oil, Aloe Barbadensis Leaf Extract, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

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
OKeeffes Lip Repair 2.5 g/100g; 17.5 g/100g; 6 g/100g; 2 g/100gthis 71564-0001-42 The 1 cylinder — — 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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71564-0001-42 You're viewing this 1 CYLINDER in 1 BLISTER PACK (71564-001-42) / 4.2 g in 1 CYLINDER 2018-03-22 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 71564-001-42, 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: 71564-0001-42, written without dashes as 71564000142. 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 71564-0001-42, the first segment (71564) is the labeler code FDA assigned to The Gorilla Glue Company/O'Keeffe's Company; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (42) 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 The Gorilla Glue Company/O'Keeffe's Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Gorilla Glue Company/O'Keeffe's Company 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 39 words ▾

Uses temporarily protects and helps relieve chapped or cracked lips helps prevent sunburn if 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 93 words ▾

Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures: Spending time in the sun increases your 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: ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 11 words ▾

Other information Protect this product from excessive heat and direct sun

🧪 Active Ingredient 10 words ▾

Active ingredients Avobenzone 2.5% Dimethicone 17.5% Octinoxate 6% Octocrylene 2%

🧪 Inactive Ingredients 48 words ▾

Inactive ingredients Beeswax, Petrolatum, Hydrogenated Poly (C6-14 Olefin), Phenyl Trimethicone, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Butyrospermum Parkii (Shea) Butter, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Flavor, Polysilicone-11, Hydrogenated Polyisobutane, Hydrogenated Vegetable Oil, Ethylene/Propylene/Styrene Copolymer, Sodium Saccharin, Citrus Aurantifolia (Lime) Peel Oil, Aloe Barbadensis Leaf Extract, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

🎯 Purpose 6 words ▾

Purposes Sunscreen Lip Protectant Sunscreen Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71558-0590-28 · Insmed 71564-0006-03 · The →
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.