HomeNDC LookupIngredientsZinc Oxide › 61481-3008-01
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45 Zinc Oxide 22 g/100g Stick, 4.2 g — NDC 61481-3008-01 package photo

KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45 Zinc Oxide 22 g/100g Stick, 4.2 g

by Wilc Healthcare Inc · 4.2 g in 1 TUBE (61481-3008-1)
NDC 61481-3008-01
🏷️ FDA NDC (as labeled) 61481-3008-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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

FDA NDC (as labeled) 61481-3008-1
Product NDC 61481-3008
11-digit billing NDC 61481300801
UNII SOI2LOH54Z
UPC 0778817065122
Application # M020
SPL Set ID 247a323f-9a08-4717-8553-ebc9c519817b
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 2023-04-10
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 61481-3008-1 — 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 → 61481-3008-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerWilc Healthcare Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61481
First marketedApr 2023
Product typeHuman Otc Drug
Portfolio8 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a mineral sunscreen stick applied to the skin to help protect against sunburn and sun damage. It contains zinc oxide, a physical sunscreen ingredient that reflects and scatters ultraviolet light away from the skin. The product is marketed as a broad spectrum sunscreen with SPF 45 protection and is sold over the counter under the FDA's OTC sunscreen monograph, which sets standards for how sunscreen products are formulated and labeled.

Supplement & herbal interactions

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

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.

🧪 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 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 137SL7IL0Y
    A waxy substance derived from sheep's wool that contains natural sterols. It acts as an emollient and emulsifier, helping blend oil and water-based ingredients together in creams and lotions.
  • UNII ZRA72DR3R7
    A waxy substance made from fatty acids and glycerin that acts as a binder and lubricant in tablets and capsules. It helps hold ingredients together and makes the medicine easier to swallow.
  • 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 832C4KF14X
    A synthetic oil derived from pentaerythritol and fatty acids. It acts as an emollient and solubilizer in formulations, helping dissolve active ingredients and improve texture and spreadability in topical or oral products.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 88R97D8U8A
    A synthetic liquid derived from propylene glycol and myristic acid. It functions as an emollient and solvent in topical formulations, helping to soften the skin and improve the texture and spreadability of the product.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

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

The official label also statesPPG-2 Myristyl Ether Propionate, C18-36 Acid Triglyceride, Beeswax, Pentaerythrityl Tetracaprylate /Tetracaprate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Stearyl Alcohol, Butyloctyl Salicylate, C10-30 Cholesterol/Lanosterol Esters

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 DailyMedingredient 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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zinc Oxide 22 g/100g 69367-0188-04 Westminster 113 g $0.362 Availability likely
Trader Joe S Mineral Sunscreen 22 g/100g 71270-0150-03 Trader 1 tube FDA listed
Earth Mama Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40 22 g/100g 72812-0149-01 Earth 1 tube FDA listed
Earth Mama Lady Face Mineral Sunscreen - Medium/Dark Tint Broad Spectrum SPF 40 22 g/100g 72812-0150-01 Earth 1 tube FDA listed
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45 22 g/100g 71014-0041-01 Eai-jr 10 g FDA listed
Mineral Sunscreen SPF 50 22 g/100g 54136-0351-92 Better 92 g FDA listed
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45 22 g/100gthis 61481-3008-01 Wilc 4.2 g FDA listed
Elta MD Skincare UV Stick Broad Spectrum SPF50 22 g/100g 72043-0495-02 CP 1 cylinder FDA listed
Mineral Sunscreen SPF 50 22 g/100g 70631-0137-85 Young 85 g FDA listed
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40 22 g/100g 79747-0149-01 Eleeo 1 tube FDA listed
Kids Mineral Sunscreen Stick SPF 50 22 g/100g 83369-0004-01 Smalls 20 g FDA listed
Elta MD Skincare UV Stick Broad Spectrum SPF50 22 g/100g 72043-0606-02 CP 1 cylinder 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61481-3008-01 You're viewing this 4.2 g in 1 TUBE (61481-3008-1) 2023-04-10 Active

🧭 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 FDA registers it as 61481-3008-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61481-3008-01, written without dashes as 61481300801. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61481-3008-01, the first segment (61481) is the labeler code FDA assigned to Wilc Healthcare Inc; the middle segment (3008) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Wilc Healthcare Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Wilc Healthcare Inc 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.

📄 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 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 cased by the sun.

⏱️ Dosage and Administration 91 words

Directions Apply liberally 15 minutes before sun exposure Reapply: after 8o minutes of swimming or sweating immediately after towel drying at least every 2 hours Children under 6 months, ask a doctor. 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm wear long sleeved shirts, pants, hats and sunglasses.

⚠️ Warnings 55 words

Warnings For external use only Do not use on damaged or broken skin. When using this product avoid contact with eyes. If contact occurs, rinse with water. Stop use and ask a doctor if rash occurs. Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.

🧪 Active Ingredient 5 words

Active Ingredient Zinc Oxide 22%

🧪 Inactive Ingredients 24 words

Inactive Ingredients PPG-2 Myristyl Ether Propionate, C18-36 Acid Triglyceride, Beeswax, Pentaerythrityl Tetracaprylate /Tetracaprate, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Stearyl Alcohol, Butyloctyl Salicylate, C10-30 Cholesterol/Lanosterol Esters

🎯 Purpose 2 words

Purpose Sunscreen

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