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The Naked Bee SPF 50 Mineral Sunscreen Zinc Oxide 14.69% 14.69 g/100g Stick, 14 g — NDC 82820-0004-01 package photo

The Naked Bee SPF 50 Mineral Sunscreen Zinc Oxide 14.69% 14.69 g/100g Stick, 14 g

by The Naked Bee · 14 g in 1 CONTAINER (82820-004-01)
NDC 82820-0004-01
🏷️ FDA NDC (as labeled) 82820-004-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 82820-004-01
Product NDC 82820-004
11-digit billing NDC 82820000401
UNII SOI2LOH54Z
Application # M020
SPL Set ID f820a9be-c94d-4fd5-b202-2dda5746a82a
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 2026-05-04
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 82820-004-01 — 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 → 82820-0004-01. 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.

🏭 Manufacturer & labeler

LabelerThe Naked Bee
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82820
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio4 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 stick-form sunscreen applied to the skin. It contains zinc oxide at 14.69% strength, a mineral UV filter commonly used to help protect skin from ultraviolet rays. Zinc oxide is used in over-the-counter sunscreen products under FDA's monograph rule, which sets standards for ingredients and labeling in this category. The product is classified as an OTC monograph drug, meaning it follows established safety and effectiveness guidelines for sunscreen ingredients rather than being individually reviewed by the FDA.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • 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 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 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 0IAF2L30VS
    A synthetic chemical compound used as a plasticizer and conditioning agent in topical formulations. It helps soften and improve the flexibility of film coatings and suspensions applied to skin.
  • UNII 3V7K3IA58X
    A synthetic compound derived from glutamic acid, used as an emulsifier and skin-conditioning agent in topical formulations to help blend oil and water components and improve product texture and spreadability.
  • 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII O88E196QRF
    Sheanut oil is a natural fat extracted from shea nuts grown in Africa. It's used in medicines as an emollient, lubricant, and binding agent to improve texture, help ingredients mix smoothly, and keep the product stable.
  • UNII 6TC6NN0876
    A natural sweetener extracted from stevia plant leaves. It sweetens the medicine to improve taste without adding calories, helping make medications easier to take.
  • 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 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • UNII KFR5QEN0N9
    A synthetic plastic polymer that helps form a protective film coating on the medicine. It's used as a binder and film-former to hold the tablet or capsule together and control how quickly the drug dissolves.

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

The official label also statesButyloctyl Salicylate Butyrospermum Parkii (Shea) Oil C12-15 Alkyl Benzoate Caprilic/Capric Triglyceride Dibutyl Ethylhexanoyl Glutamide Dibutyl Lauroyl Glutamide Ethylhexyl Methoxycrylene Octyldodecanol Simmondsia Chinensis (Jojoba) Seed Oil Stevia Tocopheryl Acetate Triethoxycaprylylsilane Vitis Vinifera (Grape) Seed Oil VP/Hexadecene Copolymer

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.

💲 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
SPF 50 Mineral Sunscreen Kids 14.69 g/100g 87170-0005-01 S&C 13 g — — FDA listed —
The Naked Bee SPF 50 Mineral Sunscreen 14.69 g/100gthis 82820-0004-01 The 14 g — — FDA listed —
Aloe UP .5OZ SPF 50 MINERAL Sunscreen 14.69 g/100g 61477-0239-01 Aloe 14 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
May 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.

🔬 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 24% — the ingredient across all brands.

Top reported reactions

Sepsis2
Abdominal Abscess1
Abscess1
Blood Magnesium Decreased1
Bradycardia1
Candida Infection1
Candida Test Positive1

Reporter sex

3 reports
Male · 67%
Female · 33%

Serious outcomes

Hospitalization3
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82820-0004-01 You're viewing this 14 g in 1 CONTAINER (82820-004-01) 2026-05-04 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 82820-004-01, 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: 82820-0004-01, written without dashes as 82820000401. 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 82820-0004-01, the first segment (82820) is the labeler code FDA assigned to The Naked Bee; the middle segment (0004) 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 The Naked Bee. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Naked Bee 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 10 words ▾

Uses • Helps prevent sunburn.Higher SPF gives more sun protection.

⏱️ Dosage and Administration 150 words ▾

DIRECTIONS Shake well before using • spray liberally and spread evenly by hand 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • hold container 4 to 6 inches from the skin to apply • do not spray directly into face. Spray on hands then apply to face • do not apply in windy conditions • use in a well-ventilated area. • Sun Protection Measure s. 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: Ask a doctor.

⚠️ Warnings 69 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. • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. Stop use and ask 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 ingredients Zinc Oxide 24%

🧪 Inactive Ingredients 38 words ▾

Inactive Ingredeints Butyloctyl Salicylate Butyrospermum Parkii (Shea) Oil C12-15 Alkyl Benzoate Caprilic/Capric Triglyceride Dibutyl Ethylhexanoyl Glutamide Dibutyl Lauroyl Glutamide Ethylhexyl Methoxycrylene Octyldodecanol Simmondsia Chinensis (Jojoba) Seed Oil Stevia Tocopheryl Acetate Triethoxycaprylylsilane Vitis Vinifera (Grape) Seed Oil VP/Hexadecene Copolymer

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82820-0003-04 · The 82829-0002-99 · Astellas →
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.