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AGE20S UV MINERAL PRIMING SUNSCREEN Zinc Oxide 7.34 g/50g Cream — NDC 67225-5301-5 (Billing 67225-5301-05)

by Aekyung Industrial Co., Ltd. · 1 TUBE in 1 BOX / 50 g in 1 TUBE

This is a package of AGE20S UV MINERAL PRIMING SUNSCREEN Zinc Oxide 7.34 g/50g Cream from Aekyung Industrial Co., Ltd., marketed since Nov 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 67225-5301-05
🏷️ FDA NDC (as labeled) 67225-5301-5 billing pads the package segment with a zero
This package
Contains50 g in 1 tube Pack sizes2 compare ↓
Main listing for product 67225-5301 · Also comes in: 2 tubes 67225-5301-6
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 67225-5301-5 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67225 labeler · 5301 product · 5 package
Package marketed since
Nov 17, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
8801046449110, 8801046452929
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) 67225-5301-5
Product NDC 67225-5301
11-digit billing NDC 67225530105
UNII SOI2LOH54Z
UPC 8801046449110, 8801046452929
Application # M020
SPL Set ID 43c1f70b-0664-40be-e063-6394a90a2b48
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-17
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 67225-5301-5 — a 5-4-1 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 package segment → 67225-5301-05. 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 containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter typically used in sunscreen products to help protect skin from ultraviolet rays. This product is marketed as an OTC monograph drug, meaning it is formulated under FDA's established rules for over-the-counter sunscreen products rather than as an individually approved application.

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: 2 tubes
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
67225-5301-05 You're viewing this Main listing 1 TUBE in 1 BOX / 50 g in 1 TUBE 2025-11-17 — Active
67225-5301-06 67225-5301-6 2 TUBE in 1 BOX / 50 g in 1 TUBE 2025-11-17 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 box / 50 g in 1 tube.
What NDC number is used to bill for this package of AGE20S UV MINERAL PRIMING SUNSCREEN Zinc Oxide 7.34 g/50g Cream?
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
Age20S Uv Mineral Priming Sunscreen 7.34 g/50gthis 67225-5301-05 Aekyung 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
Nov 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.

What it looks like

Color white
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 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 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 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 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 298PX4M11X
    A synthetic chemical compound that acts as an antioxidant, helping protect the medicine's active ingredients from degradation caused by light, heat, and oxygen during storage and shelf life.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • UNII J3N6X3YK96
    C15-23 alkane is a colorless, odorless oil made from petroleum hydrocarbons. In medicines, it serves as a lubricant and glidant to help tablets and capsules flow smoothly during manufacturing and prevent sticking.
  • UNII 4ZK9VP326R
    A silicone-based polymer made from long-chain oils and dimethicone. Used as a thickener, emulsifier, and texture agent to create a smooth, uniform consistency in creams and lotions.
  • UNII 3JRB8A35M0
    A mineral compound made from calcium, aluminum, boron, and silicon. It's used as a colorant and opacifying agent to give medicines their appearance and color, and sometimes helps protect ingredients from light damage.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • 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 Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII 88KCS7120E
    Ceramide 9 is a fatty lipid found naturally in skin. It's used in medicines as an emollient and skin-conditioning agent to help soften and protect the skin barrier in topical formulations.
  • UNII F1X8L2B00J
    A naturally derived fatty substance that helps bind and condition the product's texture. It works as an emollient and skin-conditioning agent in topical formulations, helping maintain moisture and smoothness.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII V7M2259XJM
    Ceramide NS is a lipid compound derived from natural sources or synthesized chemically. It works as an emollient and skin-conditioning agent that helps soften and smooth the product's texture while improving how it feels on the skin.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII F4K100DXP3
    Dibutyl adipate is a synthetic oily liquid derived from adipic acid. It serves as a plasticizer and solvent in medicines, helping softens coatings and improves flexibility so tablets and capsules don't crack or break.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • 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 3297VXM8Z6
    A plant-derived humectant and emollient made from glycerin and glucose. It helps retain moisture in the formulation and improves texture and spreadability in topical products.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • 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 G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 5LKW3C543X
    A synthetic oily liquid derived from neopentyl glycol and heptanoic acid. It serves as an emollient and solvent in formulations, helping to dissolve or suspend active ingredients and improve the texture and spreadability of topical products.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII VZ2F7U5T3D
    A silicone-based compound that reduces surface tension and foam. Used as an emulsifier and processing aid to help keep ingredients evenly mixed and improve the product's flow and appearance during manufacturing.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical 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 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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 Y3NG9WF08W
    Zeolite A is a microporous mineral powder that acts as a drying agent and absorbent in medicines. It removes moisture to keep solid formulations dry and stable during storage.

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

The official label also statesWater Dimethicone Butyloctyl Salicylate Propanediol Ethylhexyl Methoxycrylene PEG-10 Dimethicone Phenyl Trimethicone Silica Zeolite Caprylyl Methicone Glyceryl Glucoside Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone Glycerin Magnesium Sulfate Dimethicone/Vinyl Dimethicone Crosspolymer Panthenol Calcium Aluminum Borosilicate Aloe Barbadensis Leaf Extract Dipropylene Glycol Benzotriazolyl Dodecyl p-Cresol Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Triethoxycaprylylsilane C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Disteardimonium Hectorite Hydroxyacetophenone Allantoin Caprylyl Glycol Caprylhydroxamic Acid Titanium Dioxide Butylene Glycol Tin Oxide 1,2-Hexanediol Dibutyl Adipate Neopentyl Glycol Diheptanoate C15-23 Alkane Hydrogenated Lecithin Cetearyl Alcohol Stearic Acid C13-14 Alkane Bakuchiol Camellia Sinensis Leaf Extract Hyaluronic Acid Pentasodium Tetracarboxymethyl Heptadecanoyl Dipeptide-12 Tocopherol Ceramide NP Ceramide NS Cholesterol Phytosphingosine Ceramide AP Ceramide AS Ceramide EOP

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

LabelerAekyung Industrial Co., Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code67225
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio64 products on file

More NDCs from Aekyung Industrial Co., Ltd. labeler code 67225

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

■ 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 97 words ▾

■ Apply liberally 15 minutes before sun exposure. ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Todecrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ Children under 6 months of age: Ask a doctor. ■ Reapply at least every 2 hours. ■ Use a water-resistant sunscreen if swimming or sweating ■ 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

🧪 Active Ingredient 3 words ▾

Zink Oxide 14.68%

🧪 Inactive Ingredients 103 words ▾

Water Dimethicone Butyloctyl Salicylate Propanediol Ethylhexyl Methoxycrylene PEG-10 Dimethicone Phenyl Trimethicone Silica Zeolite Caprylyl Methicone Glyceryl Glucoside Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone Glycerin Magnesium Sulfate Dimethicone/Vinyl Dimethicone Crosspolymer Panthenol Calcium Aluminum Borosilicate Aloe Barbadensis Leaf Extract Dipropylene Glycol Benzotriazolyl Dodecyl p-Cresol Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Triethoxycaprylylsilane C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Disteardimonium Hectorite Hydroxyacetophenone Allantoin Caprylyl Glycol Caprylhydroxamic Acid Titanium Dioxide Butylene Glycol Tin Oxide 1,2-Hexanediol Dibutyl Adipate Neopentyl Glycol Diheptanoate C15-23 Alkane Hydrogenated Lecithin Cetearyl Alcohol Stearic Acid C13-14 Alkane Bakuchiol Camellia Sinensis Leaf Extract Hyaluronic Acid Pentasodium Tetracarboxymethyl Heptadecanoyl Dipeptide-12 Tocopherol Ceramide NP Ceramide NS Cholesterol Phytosphingosine Ceramide AP Ceramide AS Ceramide EOP

🎯 Purpose 2 words ▾

Sunscreen Sunscreen

📄 Do Not Use 7 words ▾

■ on damaged skin or broken skin

📄 When Using This Product 10 words ▾

■ keep out of eyes. Rinse with water to remove.

📄 Stop Use and Ask a Doctor If 10 words ▾

stop use and ask a doctor if ■ rash occurs.

📄 Keep Out of Reach of Children 12 words ▾

If swallowed, get medical help or contact poison control center right away

📄 Other Information 45 words ▾

■ Protect the product in the container from excessive heat and avoid storing it under direct sun. ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

📄 Package Label / Principal Display Panel 3 words ▾

2ae box product

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Zinc Oxide — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation256

Age at onset

Neonate6
Infant11
Child35
Adolescent8
Adult218
Elderly272

Reporter sex

3,195 reports

Serious outcomes

Hospitalization1,367
Death290
Life-threatening166
Disabling63
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 365 112
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 Aekyung Industrial Co., Ltd.. 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 2 tubes (67225-5301-06). 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?
Aekyung Industrial 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.
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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.