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Luminous Defense SPF 50 ZINC OXIDE 120 mg/mL Lotion — NDC 84163-0056-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Luminous Defense SPF 50 ZINC OXIDE 120 mg/mL Lotion — NDC 84163-056-15 (Billing 84163-0056-15)

by Levels 2 Skin · 1 BOTTLE, PLASTIC in 1 BOX / 30 mL in 1 BOTTLE, PLASTIC

This is a package of Luminous Defense SPF 50 ZINC OXIDE 120 mg/mL Lotion from Levels 2 Skin, marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.

NDC 84163-0056-15
🏷️ FDA NDC (as labeled) 84163-056-15 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 84163-056-15 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84163 labeler · 056 product · 15 package
Package marketed since
Jan 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8416305615 0
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) 84163-056-15
Product NDC 84163-056
11-digit billing NDC 84163005615
UNII SOI2LOH54Z
Application # M020
SPL Set ID 22e177b3-beea-212e-e063-6394a90a1452
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 84163-056-15 — 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 → 84163-0056-15. 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?

Luminous Defense SPF 50 is a topical lotion containing zinc oxide, an inorganic mineral commonly used in sunscreen products to block and reflect ultraviolet (UV) radiation from the sun. This product is an over-the-counter monograph drug, meaning it is made and sold under FDA rules for sunscreen ingredients without individual brand approval. Zinc oxide typically functions as a broad-spectrum UV filter to help protect skin from both UVA and UVB exposure.

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
84163-0056-15 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 BOX / 30 mL in 1 BOTTLE, PLASTIC 2025-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 120 mg/mL 00299-4110-00 Galderma 1 bottle — — FDA listed —
Personalized Day Moisturizer with SPF 120 mg/mL 73572-0003-30 Proven 30 ml — — FDA listed —
Personalized Day Moisturizer with SPF 50 120 mg/mL 73572-0007-01 Proven 30 ml — — FDA listed —
KISS MY FACE SPF-50 Baby Mineral Sunscreen 120 mg/mL 74154-0317-00 WINDMILL 118 ml — — FDA listed —
KISS MY FACE SPF-50 Daily Mineral Sunscreen 120 mg/mL 74154-0318-00 WINDMILL 118 ml — — FDA listed —
KISS MY FACE SPF-50 Face Factor Mineral Sunscreen 120 mg/mL 74154-0319-00 WINDMILL 59 ml — — FDA listed —
Halo Glow Skin Tint SPF 50 84513 120 mg/mL 76354-0559-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84514 120 mg/mL 76354-0560-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84520 120 mg/mL 76354-0666-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Alabaster 120 mg/mL 83249-0004-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Spice 120 mg/mL 83249-0013-01 Rms 1 bottle — — FDA listed —
Luminous Defense SPF 50 120 mg/mLthis 84163-0056-15 Levels 1 bottle — — FDA listed —
Guidance To Glow Tru Spf 35 120 mg/mL 84444-0506-00 GUIDANCE 1 tube — — FDA listed —
Avene Face Sunscreen SPF 50 120 mg/mL 64760-0782-01 Pierre 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84510 120 mg/mL 76354-0556-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84512 120 mg/mL 76354-0558-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84521 120 mg/mL 76354-0667-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Tawny 120 mg/mL 83249-0015-01 Rms 1 bottle — — FDA listed —
Avene Multi-Defense Fluid 120 mg/mL 64760-0778-01 Pierre 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Mocha 120 mg/mL 83249-0011-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Toffee 120 mg/mL 83249-0016-01 Rms 1 bottle — — FDA listed —
Halo Glow Skin Tint SPF 50 84515 120 mg/mL 76354-0561-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84518 120 mg/mL 76354-0664-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Honey 120 mg/mL 83249-0008-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Ivory 120 mg/mL 83249-0009-01 Rms 1 bottle — — FDA listed —
Halo Glow Skin Tint SPF 50 84504 120 mg/mL 76354-0550-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84508 120 mg/mL 76354-0554-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Tan 120 mg/mL 83249-0014-01 Rms 1 bottle — — FDA listed —
Avene Multi-Defense Fluid Tinted 120 mg/mL 64760-0779-01 Pierre 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84509 120 mg/mL 76354-0555-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84511 120 mg/mL 76354-0557-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF 50 84506 120 mg/mL 76354-0552-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Buff 120 mg/mL 83249-0005-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Cameo 120 mg/mL 83249-0006-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Mahogany 120 mg/mL 83249-0010-01 Rms 1 bottle — — FDA listed —
Halo Glow Skin Tint SPF 50 84507 120 mg/mL 76354-0553-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84516 120 mg/mL 76354-0662-01 e.l.f. 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84517 120 mg/mL 76354-0663-01 e.l.f. 1 tube — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Caramel 120 mg/mL 83249-0007-01 Rms 1 bottle — — FDA listed —
Rms Suncoverup Super Tint Spf 50 Sand 120 mg/mL 83249-0012-01 Rms 1 bottle — — FDA listed —
Bubble Solar Mate Daily Mineral Sunscreen SPF 40 120 mg/mL 83509-0156-01 Bubble 1 tube — — FDA listed —
Halo Glow Skin Tint SPF50 -84519 120 mg/mL 76354-0665-01 e.l.f. 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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 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 OT12HJU3AR
    A plant-derived compound used as a skin-conditioning agent and antioxidant in topical formulations. It helps stabilize the product and may improve skin feel and texture in creams or lotions.
  • 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 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 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 7F0EV20QYL
    Jojoba oil is a liquid wax extracted from jojoba plant seeds. In medications, it serves as an emollient and carrier oil that helps soften skin, improve texture, and distribute active ingredients evenly in topical formulations.
  • UNII 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • 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 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 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 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 446U8J075B
    Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
  • 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 7Q0OK5DOT4
    A plant-derived emulsifier made from glycerin and ricinoleic acid (from castor oil). It helps blend oil and water-based ingredients together in formulations and improves product texture and stability.
  • 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 R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • 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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • 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 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.

The official label also statesWater, C12-15 Alkyl Benzoate, Jojoba Esters, Caprylic/Capric Triglyceride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Tridecyl Salicylate, Niacinamide, Methylpropanediol, Silica, Bakuchiol, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Chloride, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Stearalkonium Hectorite, Lecithin, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Nylon-12, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

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

LabelerLevels 2 Skin
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84163
First marketedJan 2025
Product typeHuman Otc Drug
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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 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 98 words ▾

Directions Shake well before use Apply generously 15 minutes before sun exposure Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 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 children under 6 months of age, ask a doctor

⚠️ Warnings 55 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 occurs Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Oxide 12%

🧪 Inactive Ingredients 57 words ▾

Inactive Ingredients Water, C12-15 Alkyl Benzoate, Jojoba Esters, Caprylic/Capric Triglyceride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Tridecyl Salicylate, Niacinamide, Methylpropanediol, Silica, Bakuchiol, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Chloride, Caprylyl Glycol, Bisabolol, Allantoin, Oryza Sativa (Rice) Bran Extract, Stearalkonium Hectorite, Lecithin, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Phenylpropanol, Nylon-12, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Sodium Hydroxide.

🎯 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 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If product is swallowed, get medical help or contact 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 comments? Contact [email protected]

📄 Package Label / Principal Display Panel 3 words ▾

Product Label 1

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 Levels 2 Skin. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Levels 2 Skin 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.
← 84148-0028-01 · Guangzhou 84164-0460-00 · 6174 →
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.