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Sun Shades Lip Balm Vanilla Bean Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% .1175 g/4.25g; .282 g/4.25g; .141 g/4.25g Stick, 4.25 g

by Melaleuca Inc. · 4.25 g in 1 APPLICATOR (54473-219-04)
NDC 54473-0219-04
🏷️ FDA NDC (as labeled) 54473-219-04 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) 54473-219-04
Product NDC 54473-219
11-digit billing NDC 54473021904
UNII G63QQF2NOX, 4Y5P7MUD51, 95OOS7VE0Y
Application # M020
SPL Set ID 2037cc9d-b11b-47d6-8d65-c0f9decc8ba7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-02-01
Route TOPICAL
Dosage form STICK
Substance AVOBENZONE; OCTINOXATE; OXYBENZONE
Why two NDCs? The FDA registers this code as 54473-219-04 — 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 → 54473-0219-04. 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

LabelerMelaleuca Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code54473
First marketedFeb 2013
Product typeHuman Otc Drug
Portfolio26 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?

Sun Shades Lip Balm Vanilla Bean is a topical stick product containing three active ingredients (avobenzone, octinoxate, and oxybenzone) that function as ultraviolet light filters. These chemical sunscreen agents are commonly used in lip balm formulations to help protect the lip area from sun exposure. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established category rules for sunscreen products rather than as an individually reviewed application.

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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • 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 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 D072FFP9GU
    Cetyl esters wax is a waxy substance made from natural or synthetic fatty acids. It's used as a binder, hardening agent, and coating material to give tablets and capsules their structure and texture.
  • UNII 512OYT1CRR
    Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
  • UNII L5F16ZG4ZU
    A plastic-like polymer made by combining ethylene and vinyl acetate. It's used as a binder to hold tablet ingredients together and may also serve as a coating or sustained-release agent to control how quickly the medicine dissolves.
  • 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 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 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.

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

The official label also statespetrolatum USP, beeswax, simmondsia chinensis (jojoba) seed oil, euphorbia cerifera (candelilla) wax, cetyl esters, theobroma cacao (cocoa) seed butter, flavor, C12-15 alkyl benzoate, stearyl dimethicone, tocopheryl acetate (vitamin E USP), ethylene/VA copolymer, ammonium glycrrhizate

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
Sun Shades Lip Balm Vanilla Bean .1175 g/4.25g; .282 g/4.25g; .141 g/4.25gthis 54473-0219-04 Melaleuca 4.25 g — — FDA listed —
Sun Shades Lip Balm Cranberry Tangerine .1175 g/4.25g; .282 g/4.25g; .141 g/4.25g 54473-0223-01 Melaleuca 4.25 g — — Discontinued —
Sun Shades Lip Balm Pina Colada .1175 g/4.25g; .282 g/4.25g; .141 g/4.25g 54473-0226-04 Melaleuca 4.25 g — — FDA listed —
Sun Shades Lip Balm Mountain Mint .1175 g/4.25g; .282 g/4.25g; .141 g/4.25g 54473-0220-01 Melaleuca 4.25 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

🏛️
2013
On the market since
Feb 2013
📍
2026
Currently FDA-listed
13 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
54473-0219-04 You're viewing this 4.25 g in 1 APPLICATOR (54473-219-04) 2018-01-01 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 — Not published for this NDC No photo available yet for this listing.
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 54473-219-04, 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: 54473-0219-04, written without dashes as 54473021904. 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 54473-0219-04, the first segment (54473) is the labeler code FDA assigned to Melaleuca Inc.; the middle segment (0219) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Melaleuca Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Melaleuca Inc. 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 31 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 96 words ▾

Directions ■ apply liberally 15 minutes before sun exposure ■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ children under 6 months of age: 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 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-sleeve shirts, pants, hats, and sunglasses

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 23 words ▾

■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

🧪 Active Ingredient 8 words ▾

Active ingredients Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

🧪 Inactive Ingredients 36 words ▾

Inactive Ingredients petrolatum USP, beeswax, simmondsia chinensis (jojoba) seed oil, euphorbia cerifera (candelilla) wax, cetyl esters, theobroma cacao (cocoa) seed butter, flavor, C12-15 alkyl benzoate, stearyl dimethicone, tocopheryl acetate (vitamin E USP), ethylene/VA copolymer, ammonium glycrrhizate

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54473-0218-06 · Melaleuca 54473-0220-01 · Melaleuca →
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.