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SPF 30 Mineral Sunscreen Zinc Oxide 19 g/100g Cream, 50 g — NDC 83369-003-01 (Billing 83369-0003-01)

by Smalls Brand LLC DBA Roe Wellness · 50 g in 1 CARTON

This is a package of 50 g of SPF 30 Mineral Sunscreen Zinc Oxide 19 g/100g Cream from Smalls Brand LLC DBA Roe Wellness, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 83369-0003-01
🏷️ FDA NDC (as labeled) 83369-003-01 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 83369-003-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83369 labeler · 003 product · 01 package
Package marketed since
Mar 3, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8336900301 2
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) 83369-003-01
Product NDC 83369-003
11-digit billing NDC 83369000301
UNII SOI2LOH54Z
Application # M020
SPL Set ID 4c25b4ec-b045-7066-e063-6294a90ab801
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-03
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83369-003-01 — 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 → 83369-0003-01. 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 cream containing zinc oxide, an active ingredient commonly used in over-the-counter sunscreen products to help protect skin from ultraviolet (UV) radiation. Zinc oxide functions as a physical (or mineral) UV filter that works by reflecting and scattering UV rays away from the skin. This product is formulated as an OTC monograph drug, meaning it is marketed under the FDA's established rules for sunscreen ingredients and dosages 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.
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
83369-0003-01 You're viewing this Main listing 50 g in 1 CARTON 2026-03-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Wonderscreen Tinted Broad Spectrum SPF 30 19 g/100g 82870-0005-01 Dime 50 g — — FDA listed —
Zoey naturals Broad Spectrum SPF 50 Fragrance Free Sunscreen 19 g/100g 70793-0033-68 Absolutely 19.5 g — — FDA listed —
Lather Daily Defense Mineral SPF 45 Facial Sunscreen 19 g/100g 77394-0204-02 Lather, 1 bottle — — FDA listed —
Wonderscreen Broad Spectrum SPF 30 19 g/100g 44717-0062-01 Wasatch 50 g — — FDA listed —
Hustle Butter Spf 50 Mineral Sunscreen 19 g/100g 72014-0202-02 H.B.D.DIST. 19.5 g — — FDA listed —
Banana Boat 19 g/100g 63354-0373-01 Edgewell 74 g — — FDA listed —
SPF 30 Mineral Sunscreen 19 g/100gthis 83369-0003-01 Smalls 50 g — — FDA listed —
Baby Donna SHeer SPF Sunscreen Stick 19 g/100g 69555-0044-01 Stream2Sea, 16 g — — FDA listed —
Smart Care Mineral-Enhanced SUNSCREEN SPF 50 19 g/100g 70108-0269-01 Ashtel 170 g — — Discontinued —
Wonderscreen Broad Spectrum SPF 30 Shade 1 19 g/100g 82870-0007-01 Dime 50 g — — FDA listed —
Banana Boat 19 g/100g 63354-0374-23 Edgewell 147 g — — FDA listed —
Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 19 g/100g 82870-0008-01 Dime 50 g — — FDA listed —
Wonderscreen Broad Spectrum SPF 30 19 g/100g 82870-0001-01 Dime 50 g — — FDA listed —
Absolutely Natural Broad Spectrum SPF 50 Sunscreen 19 g/100g 70793-0035-68 Absolutely 19.5 g — — 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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
🎯 Indications and Usage 9 words ▾

Stop use and ask a doctor if rash occurs.

⏱️ Dosage and Administration 26 words ▾

Directions: Apply liberally 5 minutes before sun or water exposure Immediately 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 19.0% Purpose: Sunscreen

🧪 Inactive Ingredients 63 words ▾

Inactive Ingredients: Water, Ethylhexyl Olivate, Dimethicone, C9-12 Alkane, Cocoglycerides, Hydroxyethyl Dimethicone Laurate, Pentylene Glycol, Butyloctyl Salicylate, Glycerin, Jojoba Esters, Pyrus Malus (Apple) Fruit Extract, Polymethylsilsesquioxane, Squalane, Dipotassium glycyrrhizate, Beta Vulgaris (Beet) Root Extract. Fructooligosaccharides. Glycine Soja (Soybean) Seed Extract Diheptyl Succinate, Disteardimonium Hectorite, Phenoxyethanol, Sodium Chloride, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Hydroxyacetophenone, Sodium Citrate, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Capryloyl Glycerin/Sebacic Acid Copolymer

🎯 Purpose 10 words ▾

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
← 83369-0002-01 · Smalls 83369-0004-01 · Smalls →
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.