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ELEVEN UNRIVALED SERUM Zinc Oxide 110 mg/mL Lotion — NDC 79163-0399-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ELEVEN UNRIVALED SERUM Zinc Oxide 110 mg/mL Lotion — NDC 79163-399-02 (Billing 79163-0399-02)

by Eco Chic, LLC · 1 BOTTLE in 1 CARTON / 28 mL in 1 BOTTLE

This is a package of ELEVEN UNRIVALED SERUM Zinc Oxide 110 mg/mL Lotion from Eco Chic, LLC, marketed since Nov 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 79163-0399-02
🏷️ FDA NDC (as labeled) 79163-399-02 billing pads the product segment with a zero
This package
Contains28 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 79163-399 · Also comes in: 8 ml 79163-399-03
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 79163-399-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
79163 labeler · 399 product · 02 package
Package marketed since
Nov 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0850015162633
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79163-399-02
Product NDC 79163-399
11-digit billing NDC 79163039902
UNII SOI2LOH54Z
UPC 0850015162633
Application # M020
SPL Set ID f4bdacb9-bedd-c9cc-e053-2995a90a5786
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-11-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 79163-399-02 — 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 → 79163-0399-02. 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?

Eleven Unrivaled Serum is a topical lotion containing zinc oxide as its active ingredient. Zinc oxide is commonly used in over-the-counter skin care products to help protect and soothe the skin. This product is marketed as an OTC monograph drug, meaning it is formulated to meet FDA standards for products in this category rather than being individually reviewed. The lotion form is applied directly to the skin.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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 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: 8 ml
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
79163-0399-02 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 28 mL in 1 BOTTLE 2022-11-01 — Active
79163-0399-03 79163-399-03 8 mL in 1 BOTTLE Sample 2022-11-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 28 ml in 1 bottle.
What NDC number is used to bill for this package of ELEVEN UNRIVALED SERUM Zinc Oxide 110 mg/mL Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Iris and Romeo Weekend Skin Moisture Lip Balm - Carob 110 mg/mL 83247-2490-02 Iris 1 pail — — FDA listed —
Iris and Romeo Weekend Skin Moisture Lip Balm - Cameo 110 mg/mL 83247-2765-02 Iris 1 bottle — — FDA listed —
Credo Skin Solar Limits Serum 110 mg/mL 79163-0255-02 Eco-Chic 1 bottle — — FDA listed —
ELEVEN BY VENUS WILLIAMS ACE THE DAY Face 110 mg/mL 79163-0386-02 Eco-Chic 1 bottle — — FDA listed —
Eleven Unrivaled Serum 110 mg/mLthis 79163-0399-02 Eco 1 bottle — — FDA listed —
Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn 110 mg/mL 83247-2489-02 Iris 1 bottle — — FDA listed —
Iris and Romeo Weekend Skin Moisture Lip Balm 110 mg/mL 83247-6319-02 Iris 1 bottle — — Discontinued —
Iris and Romeo Weekend Skin Moisture Lip Balm - Suede 110 mg/mL 83247-2764-02 Iris 1 bottle — — FDA listed —
Iris and Romeo Weekend Skin Moisture Lip Balm - Iconic 110 mg/mL 83247-2767-02 Iris 1 bottle — — FDA listed —
Alleyoop Sun Serum Lip Oil - Hazy 110 mg/mL 84830-2282-02 NewAlley 1 bottle — — FDA listed —
Mental Skin Care Lip Shield Inspire 110 mg/mL 82696-4400-02 Mental 1 bottle — — FDA listed —
Iris and Romeo Weekend Skin Cool Glow 110 mg/mL 83247-2544-02 Iris 1 tube — — FDA listed —
Iris and Romeo Weekend Skin Bronze Glow 110 mg/mL 83247-2195-02 Iris 1 tube — — FDA listed —
Alleyoop Sun Serum Lip Oil - Whirlwind 110 mg/mL 84830-2120-02 NewAlley 1 bottle — — FDA listed —
Credo Follain Daily Mineral Sunscreen 110 mg/mL 79163-0138-02 Eco-Chic 1 tube — — FDA listed —
Iris and Romeo Weekend Skin Moisture Lip Balm - Camellia 110 mg/mL 83247-2514-02 Iris 1 bottle — — FDA listed —
Sunsovle MD Volumize and Restore 110 mg/mL 84878-0823-02 Sunsolve 1 bottle — — FDA listed —
Riversol Tinted Lip Oil - Rosewood 110 mg/mL 63931-2116-02 Solesence, 1 tube — — FDA listed —
Riversol Tinted Lip Oil - Rosewood 110 mg/mL 72019-2116-02 Riversol 1 tube — — 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

🏛️
2022
On the market since
Nov 2022
📍
2026
Currently FDA-listed
4 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.

What it looks like

Color yellow
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 105S6I733Z
    A natural oil extracted from chamomile and other plants. It acts as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • 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 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 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 59JDQ5VT0T
    A natural oil extracted from bitter orange fruit. It adds flavor and aroma to the medicine and may help mask unpleasant tastes.
  • UNII 8MFF77J91V
    A natural extract from mandarin orange peel used as a flavoring agent and fragrance in medicines. It provides taste and aroma to make the product more palatable.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • UNII 1E5KJY107T
    A liquid mixture derived from coconut oil, coconut alkanes serve as a solvent and lubricant in medicines. They help dissolve active ingredients and reduce friction during manufacturing and tablet compression.
  • UNII 245J88W96L
    A plant-derived ingredient from coconut that acts as a filler and texture agent in medications. It helps create the proper consistency and bulk needed for tablets or capsules.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII V88105URGI
    A plant-derived ingredient from Hedychium spicatum, commonly known as spiked ginger lily. It may be included in formulations for flavoring, aroma, or traditional ingredient purposes.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII 0F897O3O4M
    A naturally occurring alcohol derived from plants or synthesized chemically. It functions as a preservative and flavoring agent in medicines, helping prevent microbial growth and add pleasant taste to oral products.
  • UNII 9229XJ4V12
    A synthetic emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients in formulations, keeping them mixed and preventing separation.
  • UNII 46P231IQV8
    A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
  • UNII MZQ63P0N0W
    A plant-derived emulsifier made from glycerin and castor oil. It helps mix oil and water ingredients together in formulations like creams and lotions, keeping them blended.
  • UNII 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 5G06TVY3R7
    Rutin is a plant-derived compound that acts as an antioxidant in medicines. It helps protect the product from degradation during storage and may improve stability.
  • UNII V2CI786FPG
    A plant-derived emollient made from shea butter, used in topical formulations to soften the skin and improve texture. It helps stabilize oil and water mixtures and creates a smooth, spreadable consistency in creams and ointments.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • 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 AZQ08K38Z1
    A synthetic oily liquid derived from salicylic acid. It works as an emollient and penetration enhancer in topical formulations, helping active ingredients absorb into skin while conditioning and softening the application area.
  • UNII BOS0R5Y21O
    A flavoring ingredient derived from vanilla orchid pods. It adds vanilla taste and aroma to make the medicine more palatable, especially in products for children or those requiring better taste masking.
  • 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.

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

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

LabelerEco Chic, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code79163
First marketedNov 2022
Product typeHuman Otc Drug

More NDCs from Eco Chic, LLC labeler code 79163

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

ELEVEN UNRIVALED SERUM Indications & usage

⏱️ Dosage and Administration 6 words ▾

ELEVEN UNRIVALED SERUM Dosage and Administration

⚠️ Warnings 5 words ▾

ELEVEN UNRIVALED SERUM Warning Label

🧪 Active Ingredient 5 words ▾

ELEVEN UNRIVALED SERUM Active Ingredients

🧪 Inactive Ingredients 5 words ▾

ELEVEN UNRIVALED SERUM Inactive ingredients

🎯 Purpose 4 words ▾

ELEVEN UNRIVALED SERUM purpose

📄 Keep Out of Reach of Children 9 words ▾

ELEVEN UNRIVALED SERUM keep out of reach of children

📄 Package Label / Principal Display Panel 4 words ▾

ELEVEN UNRIVALED SERUM PDP

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 Eco Chic, 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 8 ml (79163-0399-03). 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?
Eco Chic, 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.
← 79163-0386-02 · Eco-Chic 79165-0777-20 · Alta →
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.