Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Hello Bello Mineral Sunscreen SPF 50 Zinc Oxide 253 mg/mL Lotion — NDC 51326-615-23 (Billing 51326-0615-23)
by Topiderm, Inc. · 1 BOTTLE, PLASTIC in 1 BOX / 148 mL in 1 BOTTLE, PLASTIC
This is a package of Hello Bello Mineral Sunscreen SPF 50 Zinc Oxide 253 mg/mL Lotion from Topiderm, Inc., marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.
NDC 51326-0615-23
🏷️ FDA NDC (as labeled)
51326-615-23
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 51326-615-23 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 51326 labeler · 615 product · 23 package
- Package marketed since
- Jul 29, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5132661523 3
- FDA record last changed
- Sep 3, 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)
51326-615-23
Product NDC
51326-615
11-digit billing NDC
51326061523
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
54f12764-5c37-4a05-bf96-209fedb93fd1
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-07-29
Route
TOPICAL
Dosage form
LOTION
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 51326-615-23 — 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 → 51326-0615-23. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
This is a topical lotion sunscreen containing zinc oxide, an inorganic mineral ingredient commonly used to protect skin from ultraviolet (UV) radiation. Zinc oxide works by sitting on the skin surface and physically blocking or scattering UV rays. The product is marketed as an over-the-counter sunscreen under FDA's monograph rules for the sunscreen drug category, meaning it follows established safety and ingredient standards rather than undergoing individual product review.
Patient education
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 51326-0615-23 You're viewing this Main listing | 1 BOTTLE, PLASTIC in 1 BOX / 148 mL in 1 BOTTLE, PLASTIC | 2026-07-29 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hello Bello Mineral Sunscreen SPF 50 253 mg/mLthis 51326-0615-23 | Topiderm, | 1 bottle | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2026
On the market since
Jul 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
-
UNII 54JB35T06A
A natural oil extracted from apricot pits, used as an emollient and lubricant in topical products. It helps soften the skin and improves the texture and spreadability of creams and lotions.
-
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 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 P0M7O4Y7YD
A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
-
UNII UPY805K99W
A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
-
UNII 5L694Y0T22
A silicone-based lubricant derived from cetyl alcohol and dimethicone. It reduces friction between tablet particles and equipment surfaces, helping pills slide smoothly during manufacturing and making them easier to swallow.
-
UNII YY7C30VXJT
A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII TM2TZD4G4A
A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
-
UNII 4CG9F9W01Q
A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
-
UNII YSE9PPT4TH
Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
-
UNII ZF94AP8MEY
Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
-
UNII DE08037SAB
Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
-
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 AKN3KSD11B
Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
-
UNII 820DPX33S7
A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
-
UNII 0W8RRI5W5A
A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
-
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 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.
20 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesButyloctyl Salicylate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Csprylhydroxamic Acid, Cetyl Dimetehicone, Citrus Aurantium Dulcis (Orange) Peel Oil, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Glyceryl Caprylate, /Glyceryl Hydrogenated Rosinate, Hexyl Laurate, Hydrogenated Castor Oil, Magnesium Sulfate, Persea Gratissima (Avocado) Oil, Polyglyceryl-4 Isostearate, Prunus Armeniaca (Apricot) Kernel Oil, Purified Water, Sorbitan Sesquioleate, Triethoxycaprylsilane, Tocopherol, Sodium Hyaluronate,
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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerTopiderm, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code51326
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio47 products on file
More NDCs from Topiderm, Inc. labeler code 51326
- Topicals Clearly Mist Salicylic Acid 20 mg/mL Liquid NDC 51326-307-01
- Topix Mineral Mattifying Tinted Sunscreeninted SPF 50 Zinc Oxide 205 mg/g Lotion NDC 51326-370-01
- Replenix Acne Benzoyl Peroxide 50 mg/g Gel NDC 51326-411-57
- Replenix Acne Benzoyl Peroxide 100 mg/g Gel NDC 51326-412-57
- RFA Purifying Cleanser Clear and Clarify Salicylic Acid 20 mg/mL Liquid NDC 51326-502-01
- Hello Bello Diaper Rash Cream Zinc oxide 140 mg/g Cream NDC 51326-529-01
- Gly-Sal 10-2 Salicylic Acid 20 mg Cloth NDC 51326-712-60
- Dr. Zenovia Clear Complexion Salicylic Acid 20 mg Cloth NDC 51326-801-01
- Dr. Zenovia Spot Treatment Benzoyl Peroxide 50 mg/mL Liquid NDC 51326-802-01
- Dr. Zenovia Acne Cleanser Benzoyl Peroxide 100 mg/mL Liquid NDC 51326-803-01
- Antioxidant Sunscreen SPF 40 Octinoxate and Zinc Oxide 75 mg/mL; 70 mg/mL Lotion NDC 51326-829-03
- Replenix BP Acne Benzoyl Peroxide 100 mg/g Gel NDC 51326-841-20
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses Helps prevent sunburns 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 ▾
Directions Apply liberally 15 minutes before sun exposure, Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least evert 2 hours when exposed to sun 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 10 am – 2 pm Wear long-sleeved shirts, hats and sunglasses For children under 6 months, ask a doctor
⚠️ Warnings ▾
Warnings For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information Protect this product from excessive heat and direct sun, May stain or damage some fabrics
🧪 Active Ingredient ▾
Active Ingredient Zinc Oxide 23.5%
🧪 Inactive Ingredients ▾
Inactive Ingredients Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Csprylhydroxamic Acid, Cetyl Dimetehicone, Citrus Aurantium Dulcis (Orange) Peel Oil, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Glyceryl Caprylate, /Glyceryl Hydrogenated Rosinate, Hexyl Laurate, Hydrogenated Castor Oil, Magnesium Sulfate, Persea Gratissima (Avocado) Oil, Polyglyceryl-4 Isostearate, Prunus Armeniaca (Apricot) Kernel Oil, Purified Water, Sorbitan Sesquioleate, Triethoxycaprylsilane, Tocopherol, Sodium Hyaluronate,
🎯 Purpose ▾
Purpose Sunscreen
📄 Do Not Use ▾
Do not use on damaged or broken skin.
📄 When Using This Product ▾
When using this product keep out of eyes. Rinse with water to remove.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if rash occurs.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions? [email protected]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label 23.5% Non-Nano Zinc Oxide hello bello ™ BABY Mineral Sunscreen Lotion SPF 50 Broad Spectrum UVA + UVB Protection Dermatologist Tested Water Resistant (80 minutes) No Reef-Banned Actives Created Without: × Chemical Sunscreens × Phthalates × Parabens × Synthetic Fragrances 5 FL OZ (148 mL) PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label
No label section mentions that — try another word, or open the full label on DailyMed below.
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
Age at onset
Reporter sex
Male · 36%
Female · 64%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 Topiderm, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topiderm, 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.
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.