Home › NDC Lookup › Ingredients › Zinc Oxide › 69039-0828-02
💊image loading
(from DailyMed)

Baby Bum Mineral 50 Mineral Sunscreen Face Stick ZINC OXIDE 192 mg/g Stick

by Sun Bum, LLC · 1 TUBE, WITH APPLICATOR in 1 BLISTER PACK (69039-828-02) / 13 g in 1 TUBE, WITH APPLICATOR (69039-828-01)
NDC 69039-0828-02
🏷️ FDA NDC (as labeled) 69039-828-02 billing pads the product 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 69039-828-02
Product NDC 69039-828
11-digit billing NDC 69039082802
UNII SOI2LOH54Z
UPC 0871760002791
Application # M020
SPL Set ID 3d3a0d5c-a366-22fc-e063-6394a90a308b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-01
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 69039-828-02 — 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 → 69039-0828-02. 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

LabelerSun Bum, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69039
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio116 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 an over-the-counter sunscreen stick applied to the face to help protect skin from sunburn. The active ingredient is zinc oxide, a mineral UV filter that works by reflecting and scattering ultraviolet rays away from the skin. Zinc oxide is commonly used in broad-spectrum sunscreens and is often chosen for sensitive skin because it sits on the skin surface rather than being absorbed. This product is marketed under the FDA's monograph rules for sunscreen ingredients.

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.

🧪 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 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 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 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 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • 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 Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • 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 84XB4DV00W
    Linseed oil is a plant-based oil extracted from flax seeds. It's used in medicines as an emollient and lubricant to improve texture and help with ingredient mixing in formulations.
  • UNII SST9XCL51M
    Oryzanol is a plant compound extracted from rice bran oil. It's used in medicines as an antioxidant and emollient to help stabilize the formula and improve texture.
  • UNII 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • UNII 512OYT1CRR
    Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
  • 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.

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

The official label also statesCocos Nucifera (Coconut) Oil Persea Gratissima (Avocado) Oil Limnanthes Alba (Meadowfoam) Seed Oil Linum Usitatissimum (Linseed) Seed Oil Oryza Sativa (Rice Bran) Wax Butyloctyl Salicylate Ozokerite Copernicia Cerifera (Carnauba) Wax Butyrospermum Parkii (Shea Butter) Oryzanol Euphorbia Cerifera (Candelilla) Wax Theobroma Cacao (Cocoa) Seed Butter Carthamus Tinctorius (Safflower) Seed Oil Jojoba Esters Tocopherol 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.

💲 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
Baby Bum Mineral 50 Mineral Sunscreen Face Stick 192 mg/gthis 69039-0828-02 Sun 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
Jan 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.

🔬 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 Baby Bum Mineral 50 Mineral Sunscreen Face Stick (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69039-0828-02 You're viewing this 1 TUBE, WITH APPLICATOR in 1 BLISTER PACK (69039-828-02) / 13 g in 1 TUBE, WITH APPLICATOR (69039-828-01) 2025-01-01 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 — 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 FDA registers it as 69039-828-02, 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: 69039-0828-02, written without dashes as 69039082802. 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 69039-0828-02, the first segment (69039) is the labeler code FDA assigned to Sun Bum, LLC; the middle segment (0828) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Sun Bum, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sun Bum, LLC 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 31 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 caused by the sun

⏱️ Dosage and Administration 9 words ▾

Directions • apply liberally 15 minutes before sun exposure

⚠️ Warnings 54 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. 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 right away.

🧪 Active Ingredient 5 words ▾

Active Ingredients Zinc Oxide 19.2%

🧪 Inactive Ingredients 55 words ▾

Inactive Ingredients Cocos Nucifera (Coconut) Oil Persea Gratissima (Avocado) Oil Limnanthes Alba (Meadowfoam) Seed Oil Linum Usitatissimum (Linseed) Seed Oil Oryza Sativa (Rice Bran) Wax Butyloctyl Salicylate Ozokerite Copernicia Cerifera (Carnauba) Wax Butyrospermum Parkii (Shea Butter) Oryzanol Euphorbia Cerifera (Candelilla) Wax Theobroma Cacao (Cocoa) Seed Butter Carthamus Tinctorius (Safflower) Seed Oil Jojoba Esters Tocopherol Bisabolol

🎯 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 ↗
← 69039-0827-02 · Sun 69039-0829-02 · Sun →
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.