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ETADERM Tattoo Sunscreen Broad Spectrum SPF-30 ZINC OXIDE 150 mg/mL Cream, 118 mL — NDC 84180-472-00 (Billing 84180-0472-00)

by NUEPHASE LLC · 118 mL in 1 BOTTLE

This is a package of 118 mL of ETADERM Tattoo Sunscreen Broad Spectrum SPF-30 ZINC OXIDE 150 mg/mL Cream from NUEPHASE LLC, marketed since Apr 2024 and currently FDA-listed. It is this product's only package size.

NDC 84180-0472-00
🏷️ FDA NDC (as labeled) 84180-472-00 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 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 84180-472-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84180 labeler · 472 product · 00 package
Package marketed since
Apr 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0197644426591
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) 84180-472-00
Product NDC 84180-472
11-digit billing NDC 84180047200
UNII SOI2LOH54Z
UPC 0197644426591
Application # M020
SPL Set ID cc1e3485-57e6-4ac9-96b3-2d683beb5b53
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84180-472-00 — 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 → 84180-0472-00. 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 a topical cream sunscreen formulated with zinc oxide 150 mg/mL, marketed as an over-the-counter monograph product under FDA's established rules for sunscreen ingredients. Zinc oxide is a mineral UV filter typically used in sunscreen products to help reflect and scatter ultraviolet rays from the sun. This product is labeled as broad-spectrum SPF-30 and is designed for application to skin to help reduce sun exposure, including to tattooed areas.

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.
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
84180-0472-00 You're viewing this Main listing 118 mL in 1 BOTTLE 2024-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proven Personalized Day Moisturizer With SPF 50 150 mg/mL 73572-0004-30 Proven 30 ml — — FDA listed —
MIAMI BEACH BUM Save Face SPF-30 Sunscreen 150 mg/mL 82812-0336-00 MIAMI 100 ml — — FDA listed —
MIAMI BEACH BUM Blocked SPF-30 Sunscreen 150 mg/mL 82812-0337-00 MIAMI 180 ml — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Tinted Moisturizer 150 mg/mL 90086-0012-01 Clean 40 ml — — FDA listed —
SEAWEED BATH CO Everyday Mineral SPF 40 150 mg/mL 81159-0259-00 The 100 ml — — FDA listed —
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen 150 mg/mL 82812-0958-00 Miami 100 ml — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four 150 mg/mL 90086-0017-01 Clean 1 tube — — FDA listed —
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30 150 mg/mL 83005-0002-01 Sqween 118 ml — — FDA listed —
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30 150 mg/mLthis 84180-0472-00 NUEPHASE 118 ml — — FDA listed —
Oathology Inzincable Lip Balm SPF 35 150 mg/mL 85562-0694-00 SKINOATH 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and Half 150 mg/mL 90086-0016-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five 150 mg/mL 90086-0019-01 Clean 1 tube — — FDA listed —
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30 150 mg/mL 69039-0761-02 Sun 1 bottle — — FDA listed —
Saie Sunvisor Broad Spectrum SPF 35 Sheer Moisturizer 150 mg/mL 90086-0011-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and Half 150 mg/mL 90086-0018-01 Clean 1 tube — — FDA listed —
Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen 150 mg/mL 64657-0007-02 Naturopathica 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three 150 mg/mL 90086-0015-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine 150 mg/mL 90086-0024-01 Clean 1 tube — — FDA listed —
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant 150 mg/mL 83005-0001-01 SQWEEN 60 ml — — FDA listed —
Good Weather Skin The One Daily Sun Warm Glow SPF 30 150 mg/mL 85090-0002-01 Good 1 bottle — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and Half 150 mg/mL 90086-0025-01 Clean 1 tube — — FDA listed —
Lion Pose Ghost-Buster Broad Spectrum Spf 42 Sunscreen 150 mg/mL 83605-0001-01 Lion 2 ml — — Discontinued —
Cancer Council Mineral Fluid SPF50 150 mg/mL 84258-0006-01 Vitality 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade One 150 mg/mL 90086-0013-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwo 150 mg/mL 90086-0014-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Eight 150 mg/mL 90086-0023-01 Clean 1 tube — — FDA listed —
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32 150 mg/mL 71782-0201-03 DUKE 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Ten 150 mg/mL 90086-0026-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and Half 150 mg/mL 90086-0020-01 Clean 1 tube — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Six 150 mg/mL 90086-0021-01 Clean 1 tube — — FDA listed —
Lion Pose Unghosted Tinted Mineral Spf 42 Uva Uvb Sunscreen 150 mg/mL 83605-0002-01 Lion 1 bottle — — FDA listed —
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Seven 150 mg/mL 90086-0022-01 Clean 1 tube — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Light Green 150 mg/mL 83005-0005-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue 150 mg/mL 83005-0003-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Blue 150 mg/mL 58419-0011-00 Atlantis 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Pink 150 mg/mL 83005-0006-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Gold 150 mg/mL 83005-0004-01 Sqween 60 ml — — FDA listed —
Sqween Mineral Sunscreen Broad Spectrum SPF 30 Rose Gold 150 mg/mL 83005-0007-01 Sqween 60 ml — — 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
Apr 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 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 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 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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • 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 P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • 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 L56Z1JK48B
    A vegetable-derived ingredient used primarily as a natural colorant and flavoring agent in medicines. It provides orange-yellow color and mild taste to tablets, capsules, or liquids.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • 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 D9108TZ9KG
    Cocoa is a natural powder made from roasted cacao beans. It's used as a flavoring and coloring agent to make medicines taste better and appear brown.
  • UNII 0N8672707O
    A starch derived from corn kernels. It acts as a binder to hold tablet ingredients together, a filler to give the tablet bulk, and a disintegrant to help the tablet break apart in your stomach.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • 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 Y98611C087
    Glyceryl laurate is an emulsifier made by combining glycerin and lauric acid. It helps mix oil and water-based ingredients together in the medicine and may improve how the product feels or spreads.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin E), Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Cucumis Sativus (Cucumber) Extract, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sun flower) Oil, Hydrolyzed Collagen, Polyhydroxy stearic Acid, Polysorbate 20, Rosa Canina (Rose) Hips Oil, Sorbitan Olivate, Theobroma Cacao (Cocoa)Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

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

LabelerNUEPHASE LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84180
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from NUEPHASE LLC labeler code 84180

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

Uses: Helps prevent sun burn. higher SPF gives more sun burn protection 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 90 words ▾

Directions: Apply liberally15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating 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 broad spectrum SPF 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-sleeved shirts, pants, hats, and sunglasses.

⚠️ Warnings 68 words ▾

Warnings: For external use only Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

🧪 Active Ingredient 7 words ▾

Active Ingredients Zinc Oxide 15.00% Purpose Sunscreen

🧪 Inactive Ingredients 89 words ▾

Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin E), Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Cucumis Sativus (Cucumber) Extract, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sun flower) Oil, Hydrolyzed Collagen, Polyhydroxy stearic Acid, Polysorbate 20, Rosa Canina (Rose) Hips Oil, Sorbitan Olivate, Theobroma Cacao (Cocoa)Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

🎯 Purpose 2 words ▾

Purpose 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 13 words ▾

Stop use and ask a doctor if rash or irritation develops and lasts.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 6 words ▾

Questions? Please visit our website, www.etaderm.com

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Bottle

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 — 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 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 NUEPHASE LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NUEPHASE 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.
← 84180-0471-00 · NUEPHASE 84180-0878-00 · NUEPHASE →
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.