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Lip Renewal SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate 1.05 g/14g; .42 g/14g; 1.4 g/14g; .7 g/14g Paste, 14 g — NDC 65278-0105-01 package photo

Lip Renewal SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate 1.05 g/14g; .42 g/14g; 1.4 g/14g; .7 g/14g Paste, 14 g

by June Jacobs Labs, LLC · 14 g in 1 TUBE (65278-105-01)
NDC 65278-0105-01
🏷️ FDA NDC (as labeled) 65278-105-01 billing pads the product segment with a zero
This package
Contains14 g Pack sizes2 compare ↓
Also comes in: 14 g 65278-0105-02
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) 65278-105-01
Product NDC 65278-105
11-digit billing NDC 65278010501
UNII 4Y5P7MUD51, G63QQF2NOX, V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID 187cd4ad-781f-b0e4-e063-6394a90a414b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-12-09
Route TOPICAL
Dosage form PASTE
Substance OCTINOXATE; AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 65278-105-01 — 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 → 65278-0105-01. 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.

🏭 Manufacturer & labeler

LabelerJune Jacobs Labs, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code65278
First marketedDec 2012
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?

Lip Renewal SPF 50 is a topical paste formulated as an over-the-counter sunscreen product under the FDA's OTC monograph rules. It contains four ultraviolet (UV) filters: avobenzone, homosalate, octinoxate, and octisalate. These ingredients are typically used together to absorb and scatter UVA and UVB rays from the sun. This type of product is commonly applied to the lips to help reduce sun exposure to that sensitive 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.

💊 What it looks like

FlavorSpearmint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII H7UGK1GJCU
    Aspalathus linearis leaf is a plant extract from rooibos tea. It's used in medicines as a natural flavor and color agent, and may help preserve the product's stability.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 75GK9XIA8I
    Carvone is a naturally derived aromatic compound found in caraway and spearmint plants. In medications, it's used as a flavoring agent to improve taste and mask bitter or unpleasant flavors.
  • UNII T7EU0O9VPP
    Citral is a natural oil compound found in lemon and citrus plants. It's used in medicines as a flavoring agent and to add pleasant lemon or citrus scent to the product.
  • 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 68BAV42LRC
    A synthetic emulsifier and thickening agent derived from glycerin and stearic acid. It helps blend oil and water components in creams and lotions, and gives products a smooth, stable texture.
  • UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII D2QHA03458
    A fermented ingredient made by culturing beneficial bacteria in radish root extract. It acts as a natural preservative and humectant, helping keep the product fresh and maintain moisture in the formula.
  • UNII GFD7C86Q1W
    A natural oil extracted from citrus peels, (+)-limonene is used as a flavoring agent and solvent in medicines. It helps dissolve active ingredients and provides a lemon or orange taste.
  • UNII 930626MWDL
    A plant extract from goji berries used as a natural coloring agent and flavor enhancer in medicines. It may add color and taste while serving as a source of beneficial plant compounds in the formulation.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII CLV24I3T1D
    A plant extract from pomegranate root bark used as a natural coloring agent and flavoring component in medicines. It may also help preserve the product and provide mild astringent properties to the formulation.
  • 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 C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 71503RH8KG
    Triisostearin is a waxy fat derived from stearic acid. It acts as a binder and hardening agent in tablets and capsules, helping hold ingredients together and control how quickly the medicine dissolves.
  • UNII CHI530446X
    Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.
  • UNII C34U15ICXA
    A plant extract from grape seeds that acts as an antioxidant and preservative in medications. It helps protect the active ingredients from degrading and extends the product's shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesInactive Ingredients Microcrystalline Wax, Diisostearyl Malate, Glyceryl Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Dimethicone, Glycerin, Vitis Vinifera (Grape) Seed Oil, Flavor (Aroma), Triisostearin, Tocopherol, Squalane, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Allantoin, Water/ Aqua, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hyaluronic Acid, Phenoxyethanol, Limonene, Citral

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 gPer 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.
Try another pack size: 14 g
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
Lip Renewal SPF 50 1.05 g/14g; .42 g/14g; 1.4 g/14g; .7 g/14gthis 65278-0105-01 June 14 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

🏛️
2012
On the market since
Dec 2012
📍
2026
Currently FDA-listed
14 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
65278-0105-01 You're viewing this 14 g in 1 TUBE (65278-105-01) 2012-12-09 Active
65278-0105-02 14 g in 1 CARTON (65278-105-02) 2012-12-09 Active

Pack size FAQ

What quantity is in NDC 65278-0105-01?
NDC 65278-0105-01 contains 14 g — 14 g in 1 tube.
What is the difference between NDC 65278-0105-01 and NDC 65278-0105-02?
Both are Lip Renewal SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate 1.05 g/14g; .42 g/14g; 1.4 g/14g; .7 g/14g Paste — the drug itself is identical. NDC 65278-0105-01 is the 14 g package, while NDC 65278-0105-02 is the 14 g package.
What NDC number is used to bill for this package of Lip Renewal SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate 1.05 g/14g; .42 g/14g; 1.4 g/14g; .7 g/14g Paste?
Bill NDC 65278-0105-01 — the 11-digit billing format is 65278010501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 65278-105-01, 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: 65278-0105-01, written without dashes as 65278010501. 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 65278-0105-01, the first segment (65278) is the labeler code FDA assigned to June Jacobs Labs, LLC; the middle segment (0105) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 June Jacobs Labs, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 14 g (65278-0105-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
June Jacobs Labs, LLC 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 29 words ▾

Uses 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 and evenly every 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use as sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun especially from 10am -2 pm. wear long sleeve shirt, pants hats and sunglasses

⚠️ Warnings 5 words ▾

Warnings For External use only

🧪 Active Ingredient 6 words ▾

Active Ingredients Avobenzone...........................3.0% Homosalate...........................10.0% Octinoxate.............................7.5% Octisalate..............................5.0%

🧪 Inactive Ingredients 65 words ▾

Inactive Ingredients Microcrystalline Wax, Diisostearyl Malate, Glyceryl Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Dimethicone, Glycerin, Vitis Vinifera (Grape) Seed Oil, Flavor (Aroma), Triisostearin, Tocopherol, Squalane, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Allantoin, Water/ Aqua, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hyaluronic Acid, Phenoxyethanol, Limonene, Citral

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65278-0104-01 · June 65278-0110-01 · June →
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.