Home › NDC Lookup › Ingredients › Ethylhexyl Methoxycinnamate, Homosalate,... › 84066-0101-01
SUNSCREEN LIP BALM Ethylhexyl Methoxycinnamate, Homosalate, Polysilicone-15, Octocrylene, Butyl Methoxydibenzoylmethane 5 g/100g; 5 g/100g; 7 g/100g; 6 g/100g; 2 g/100g Lipstick, 3.2 g — NDC 84066-0101-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SUNSCREEN LIP BALM Ethylhexyl Methoxycinnamate, Homosalate, Polysilicone-15, Octocrylene, Butyl Methoxydibenzoylmethane 5 g/100g; 5 g/100g; 7 g/100g; 6 g/100g; 2 g/100g Lipstick, 3.2 g — NDC 84066-101-01 (Billing 84066-0101-01)

by Guangzhou Tata Biotechnology Co., Ltd. · 3.2 g in 1 TUBE

This is a package of 3.2 g of SUNSCREEN LIP BALM Ethylhexyl Methoxycinnamate, Homosalate, Polysilicone-15, Octocrylene, Butyl Methoxydibenzoylmethane 5 g/100g; 5 g/100g; 7 g/100g; 6 g/100g; 2 g/100g Lipstick from Guangzhou Tata Biotechnology Co., Ltd., marketed since Jan 2024 and currently FDA-listed. It is this product's only package size.

NDC 84066-0101-01
🏷️ FDA NDC (as labeled) 84066-101-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84066-101-01
Product NDC 84066-101
11-digit billing NDC 84066010101
UNII F8DRP5BB29, 5A68WGF6WM, 4Y5P7MUD51, V06SV4M95S, G63QQF2NOX
Application # M020
SPL Set ID 0f8e08bf-4b14-bdad-e063-6394a90a34e1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-25
Route TOPICAL
Dosage form LIPSTICK
Substance POLYSILICONE-15; OCTOCRYLENE; OCTINOXATE; HOMOSALATE; AVOBENZONE
Why two NDCs? The FDA registers this code as 84066-101-01 — 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 → 84066-0101-01. 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?

This is an over-the-counter lip balm marketed as a sunscreen product and sold under FDA's OTC monograph rules for topical sunscreens. It contains five active ingredients that function as ultraviolet (UV) filters: avobenzone, homosalate, octinoxate, octocrylene, and polysilicone-15. These chemical and mineral UV-blocking agents are commonly used together in lip care products to help protect the lips from sun exposure when applied topically.

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
84066-0101-01 You're viewing this Main listing 3.2 g in 1 TUBE 2024-01-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunscreen Lip Balm 5 g/100g; 5 g/100g; 7 g/100g; 6 g/100g; 2 g/100gthis 84066-0101-01 Guangzhou 3.2 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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 09TD8L5SQV
    A plant extract from the aloe arborescens species. It functions as a skin-soothing and hydrating ingredient in topical formulations, helping maintain moisture and improve texture.
  • 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 609A3V1SUA
    A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
  • 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 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 JY81OXM1OM
    A plant-based oil from coconut that has been chemically treated to solidify it. It acts as a binder and filler to help hold tablet ingredients together and give the pill its shape and firmness.
  • 18.91 g / 100 g UNII 4YI0729529
    A synthetic oil made from plant-derived hydrocarbons that has been chemically saturated. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and improve tablet handling.
  • 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 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 I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • 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 CR7307M3QZ
    Rosa canina fruit oil is a natural oil extracted from rosehip fruit. It's used in medicines as an emollient and skin-conditioning agent to help soften and smooth the product's texture or skin contact surface.
  • 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 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 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 FY36J270ES
    A synthetic chemical compound used as a plasticizer in film coatings. It makes tablet or capsule coatings flexible and durable so they don't crack or break during handling and storage.

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

The official label also stateslnactive ingredients：Hydrogenated Polydecene, Ethylhexyl Palmitate, Disostearyl Malate.OzokeriteTridecyl Trimellitate, Synthetic Wax, Dicapryly Carbonate, Polyisobutene, Microcrys-talline Wax，Fragrance, Tocopherol， Simmondsia Chinensis (Jojoba) Seed OilHydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oi.Aloe Barbadensis Extract, Helianthus Annuus (Sunfower) Seed Oil. Vitis ViniferaGrape) Seed Oil，12-Hexanediol, Citric Acid

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

LabelerGuangzhou Tata Biotechnology Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84066
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio9 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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

helps prevent sumburn if used as directed with other sun protection measures, (see Directions) decreases therisk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 82 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 children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts,pants,hats and sunglasses

⚠️ Warnings 4 words ▾

For external use only

📦 Storage and Handling 11 words ▾

Other information protect this product from excessive heat and direct sun

🧪 Active Ingredient 15 words ▾

Active ingredients Ethylhexyl Methoxycinnamate 7% Homosalate 6 % Polysilicone-15 5% Octocrylene 5% Butyl Methoxydibenzoylmethane 2%

🧪 Inactive Ingredients 44 words ▾

lnactive ingredients：Hydrogenated Polydecene, Ethylhexyl Palmitate, Disostearyl Malate.OzokeriteTridecyl Trimellitate, Synthetic Wax, Dicapryly Carbonate, Polyisobutene, Microcrys-talline Wax，Fragrance, Tocopherol， Simmondsia Chinensis (Jojoba) Seed OilHydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oi.Aloe Barbadensis Extract, Helianthus Annuus (Sunfower) Seed Oil. Vitis ViniferaGrape) Seed Oil，12-Hexanediol, Citric Acid

🎯 Purpose 1 words ▾

Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center immediately.

📄 Questions or Comments 4 words ▾

Questions or comments? +1-973-907-6739

📄 Package Label / Principal Display Panel 3 words ▾

PRINCIPAL DISPLAY PANEL

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Guangzhou Tata Biotechnology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangzhou Tata Biotechnology Co., Ltd. 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.
← 84061-0129-01 · Australian 84066-0102-01 · Guangzhou →
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.