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Liplux SPF 30 Lip Balm Classic 5 g/100g; 8 g/100g; 3 g/100g Stick, 4.2 g — NDC 79753-0012-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Liplux SPF 30 Lip Balm Classic 5 g/100g; 8 g/100g; 3 g/100g Stick, 4.2 g — NDC 79753-012-01 (Billing 79753-0012-01)

by COOLA LLC · 4.2 g in 1 TUBE

This is a package of 4.2 g of Liplux SPF 30 Lip Balm Classic 5 g/100g; 8 g/100g; 3 g/100g Stick from COOLA LLC, marketed since Jan 2020 and currently FDA-listed. It is this product's only package size.

NDC 79753-0012-01
🏷️ FDA NDC (as labeled) 79753-012-01 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 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

NDC database record

One package, one record: these facts belong to NDC 79753-012-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
79753 labeler · 012 product · 01 package
Package marketed since
Jan 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7975301201 2
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79753-012-01
Product NDC 79753-012
11-digit billing NDC 79753001201
UNII 4X49Y0596W, 5A68WGF6WM, G63QQF2NOX
Application # M020
SPL Set ID b47b5f3a-43f3-ae7a-e053-2995a90ae16d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-01
Route TOPICAL
Dosage form STICK
Substance OCTISALATE; OCTOCRYLENE; AVOBENZONE
Why two NDCs? The FDA registers this code as 79753-012-01 — 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 → 79753-0012-01. 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.

Clinical

🧪 What is this product?

Liplux SPF 30 Lip Balm is a topical stick product marketed as an over-the-counter sunscreen under FDA's monograph rules for lip protectants. It contains three UV-filtering ingredients (avobenzone, octisalate, and octocrylene) that are typically used together to absorb ultraviolet radiation and help protect lip skin from sun exposure. This type of product is commonly applied directly to the lips as part of daily sun protection routines.

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.

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
79753-0012-01 You're viewing this Main listing 4.2 g in 1 TUBE 2020-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Liplux SPF 30 Lip Balm 5 g/100g; 8 g/100g; 3 g/100gthis 79753-0012-01 COOLA 4.2 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

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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.

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 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 1IQY04O559
    A plant-based oil derived from the kernels of the Astrocaryum vulgare palm tree. It functions as an emollient and texture enhancer in formulations, helping to soften and smooth the product while improving how it spreads or absorbs.
  • UNII 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII K8NU647RJ0
    Behenyl behenate is a waxy ester derived from behenic acid. It acts as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • 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 WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and 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 D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • 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 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 9KJL21T0QJ
    Linoleic acid is an omega-6 fatty acid derived from plant oils. It serves as an emulsifier and skin conditioning agent in topical formulations, helping ingredients mix smoothly and improving product texture.
  • 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 8KQ7I65XZE
    A waxy compound derived from stearic acid, used as a thickener and emulsifier to help blend oil and water-based ingredients. It improves the texture and stability of the medicine formulation.
  • UNII 9S8867952A
    A plant-derived oil from raspberry seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften the product texture and improve skin feel.
  • UNII B3FUD0528F
    Rebaudioside A is a naturally derived sweetener extracted from stevia leaves. It sweetens the medicine without adding calories and helps mask bitter tastes to improve how the medication goes down.
  • UNII 3TNW8D08V3
    Rosa canina fruit, also called rosehip, is a natural plant extract used in medicines as a filler and to add nutritional content. It may also help with texture or act as a mild flavoring agent in the formulation.
  • UNII IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII I711F13FXM
    A natural fat extracted from cacao-like seeds, used as an emollient and texture agent in topical products. It helps soften formulations and improve spreadability on skin.
  • 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.

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

The official label also statesAloe Barbadensis Leaf Extract, Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Euphorbia Cerifera (Candelilla) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Linoleic Acid, Persea Gratissima (Avocado) Oil (Organic), Phospholipids, Phytosterols, Polyhydroxstearic Acid, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Simmondsia Chinensis (Jojoba) Seed OIl (ORGANIC), Stevia Rebaudiana Extract, Tetrahexyldecyl Ascorbate, Theobroma Grandiflorum Seed Butter (ORGANIC), Tocopherol (ORGANIC)

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.

Manufacturer & labeler

LabelerCOOLA LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code79753
First marketedJan 2020
Product typeHuman Otc Drug
Portfolio25 products on file

More NDCs from COOLA LLC labeler code 79753

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 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 87 words ▾

Directions Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating. Apply at least every 2 hours. Sun Protection Measures - to decrease your risk of cancer and early skin aging, regularly use a sunscreen wtih a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, expecially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, paints, hats, and sunglasses.

Children under 6 months: ask a doctor. correct spelling mistakes

⚠️ Warnings 51 words ▾

Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Stop use and ask doctor if skin rash occurs. Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients Avobenzone 2.9%, Octisalate 4.9%, Octocrylene 7.6% Purpose Sunscreens

🧪 Inactive Ingredients 79 words ▾

Inactive ingredients Aloe Barbadensis Leaf Extract, Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Euphorbia Cerifera (Candelilla) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Linoleic Acid, Persea Gratissima (Avocado) Oil (Organic), Phospholipids, Phytosterols, Polyhydroxstearic Acid, Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Simmondsia Chinensis (Jojoba) Seed OIl (ORGANIC), Stevia Rebaudiana Extract, Tetrahexyldecyl Ascorbate, Theobroma Grandiflorum Seed Butter (ORGANIC), Tocopherol (ORGANIC)

🎯 Purpose 2 words ▾

Purpose Sunscreens

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Other Information 11 words ▾

Other Information Protect this product from excessive heat and direct sun.

📄 Questions or Comments 5 words ▾

Questions or Concerns? Call 760-940-2125

📄 Recent Major Changes 3 words ▾

correct spelling mistakes

📄 Package Label / Principal Display Panel 7 words ▾

Primary and secondary package labels tube

cartons

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 Classic — the ingredient across all brands.

Top reported reactions

Application Site Pain3
Headache2
Application Site Erythema1
Application Site Irritation1
Application Site Rash1
Back Pain1
Burning Sensation1

Reporter sex

8 reports
Male · 29%
Female · 71%

Serious outcomes

Hospitalization1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2 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.

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 COOLA LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COOLA 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.
← 79753-0009-01 · COOLA 79753-0014-71 · COOLA, →
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.