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Kids Mineral Sunscreen Stick SPF 50 Zinc Oxide 22 g/100g Stick, 20 g — NDC 83369-0004-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Kids Mineral Sunscreen Stick SPF 50 Zinc Oxide 22 g/100g Stick, 20 g — NDC 83369-004-01 (Billing 83369-0004-01)

by Smalls Brand LLC DBA Roe Wellness · 20 g in 1 CARTON

This is a package of 20 g of Kids Mineral Sunscreen Stick SPF 50 Zinc Oxide 22 g/100g Stick from Smalls Brand LLC DBA Roe Wellness, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 83369-0004-01
🏷️ FDA NDC (as labeled) 83369-004-01 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 83369-004-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83369 labeler · 004 product · 01 package
Package marketed since
Mar 2, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8336900401 9
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) 83369-004-01
Product NDC 83369-004
11-digit billing NDC 83369000401
UNII SOI2LOH54Z
Application # M020
SPL Set ID 4c37855b-08c0-0aa7-e063-6394a90a8842
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-02
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83369-004-01 — 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 → 83369-0004-01. 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.

Clinical

🧪 What is this product?

This is a topical sunscreen stick containing zinc oxide, an over-the-counter monograph sunscreen product intended to be applied to the skin. Zinc oxide is a mineral UV filter that works by reflecting and scattering ultraviolet light away from the skin's surface. Products of this type are commonly used to help protect exposed skin from sun damage. The stick form makes it convenient for application to areas like the face and nose.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83369-0004-01 You're viewing this Main listing 20 g in 1 CARTON 2026-03-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zinc Oxide 22 g/100g 69367-0188-04 Westminster 113 g $0.368 — 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/100g 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/100gthis 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 TY3J98ZR7R
    A synthetic polymer that acts as a film-former and texture enhancer in topical formulations. It helps create a smooth, long-wearing coating on skin and improves how the product spreads and adheres.
  • 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 WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • 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 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 Q1LS2UJO3A
    Ceresin is a purified mineral wax derived from ozocerite. It functions as a binding agent, thickener, and coating material in medicines to help hold ingredients together and provide texture or protective coating.
  • 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 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII ISE9I7DNUG
    Cocoglycerides are fatty substances derived from coconut oil. They act as emulsifiers and solubilizers in medicines, helping blend water and oil-based ingredients together and improve how the body absorbs certain drugs.
  • UNII HTC7G3S2PV
    Ethylhexyl olivate is an emollient and skin-conditioning agent derived from olive oil. It helps soften the product's texture and improves how the medicine spreads or absorbs on skin or mucous membranes.
  • UNII 4PC054V79P
    A fatty acid derived from glycerin and oleic acid (a natural oil component). It acts as an emulsifier to help mix oil and water-based ingredients, and serves as a lubricant and surfactant in the formulation.
  • 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 42DG15CHXV
    A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
  • 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 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 412ZHA4T4Y
    A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
  • UNII XO45V955LT
    A natural oil extract from olives that contains compounds resistant to saponification. Used as an emollient and skin-conditioning agent to improve product texture and spreadability in topical formulations.
  • UNII 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • UNII 6RG2461FCH
    A natural plant-based wax derived from the fruit rind of Toxicodendron vernicifluum (Chinese lacquer tree). Used as a coating agent and lubricant to provide a smooth surface on tablets or capsules and improve handling during manufacturing.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • 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 3YYE6VJS0P
    A compound derived from licorice root extract combined with stearyl alcohol. It acts as an emollient and skin-conditioning agent that helps soften and smooth the product's texture while providing a protective barrier on the skin or mucous membranes.
  • 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 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.

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

The official label also statesCaprylic/capric Triglyceride, Ethylhexyl Olivate, Bis-Octyldodecylhexyl Dimer Dilinoleate Propanediol Copolymer, Coco-Caprylate/Caprate, Cocoglycerides, Candelilla (Euphorbia Cerifera) Wax, Ozokerite, Rhus Verniciflua Peel Wax, Jojoba Esters, Butylocyl Salicylate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Potassium Olivoyl Hydrolyzed Oat Protein, Squalane, Cetearyl Alcohol, Glyceryl Stearate, Tocopherol, Stearalkonium Hectorite, Olea Europaea (Olive) Oil Unsaponifiables, Stearyl Glycyrrhetinate, Glyceryl Oleate, Water, Propylene Carbonate, Caprylyl Glycol, Bisabolol

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

LabelerSmalls Brand LLC DBA Roe Wellness
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83369
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Smalls Brand LLC DBA Roe Wellness labeler code 83369

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Stop use and ask a doctor if rash occurs.

⏱️ Dosage and Administration 26 words ▾

Directions: Apply liberally 15 minutes before sun or water exposure ReapplyImmediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor

⚠️ Warnings 26 words ▾

Warning: 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.

🧪 Active Ingredient 7 words ▾

Active Ingredients: Zinc Oxide 22.0% Purpose: Sunscreen

🧪 Inactive Ingredients 67 words ▾

Caprylic/capric Triglyceride, Ethylhexyl Olivate, Bis-Octyldodecylhexyl Dimer Dilinoleate Propanediol Copolymer, Coco-Caprylate/Caprate, Cocoglycerides, Candelilla (Euphorbia Cerifera) Wax, Ozokerite , Rhus Verniciflua Peel Wax, Jojoba Esters, Butylocyl Salicylate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Potassium Olivoyl Hydrolyzed Oat Protein, Squalane, Cetearyl Alcohol, Glyceryl Stearate, Tocopherol, Stearalkonium Hectorite, Olea Europaea (Olive) Oil Unsaponifiables, Stearyl Glycyrrhetinate, Glyceryl Oleate, Water, Propylene Carbonate, Caprylyl Glycol, Bisabolol

🎯 Purpose 4 words ▾

Uses: Helps prevent sunburn.

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Package Label / Principal Display Panel 13 words ▾

Kids Mineral Sunscreen Stick 0.7 fl oz 20 g Kids SPF mineral Stick

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
Constipation257

Age at onset

Neonate6
Infant11
Child35
Adolescent8
Adult218
Elderly272

Reporter sex

3,195 reports

Serious outcomes

Hospitalization1,367
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 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 ✓ 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 Smalls Brand LLC DBA Roe Wellness. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Smalls Brand LLC DBA Roe Wellness 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.
← 83369-0003-01 · Smalls 83372-0605-01 · Biotest →
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.