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Mineral Repair SPF 45 zinc oxide 150 mg/g Lotion, 30 g — NDC 51326-0245-01 package photo

Mineral Repair SPF 45 zinc oxide 150 mg/g Lotion, 30 g

by Topiderm, Inc. · 30 g in 1 BOTTLE, PUMP (51326-245-01)
NDC 51326-0245-01
🏷️ FDA NDC (as labeled) 51326-245-01 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) 51326-245-01
Product NDC 51326-245
11-digit billing NDC 51326024501
UNII SOI2LOH54Z
Application # M020
SPL Set ID 84580f10-3119-4253-87a6-53d24a1f2227
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-07
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 51326-245-01 — 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 → 51326-0245-01. 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

LabelerTopiderm, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code51326
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio46 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?

Mineral Repair SPF 45 is a topical lotion containing zinc oxide, an over-the-counter sunscreen active ingredient marketed under FDA's monograph rules for sunscreen products. Zinc oxide functions as a mineral (physical) UV filter, reflecting and scattering ultraviolet rays away from the skin. This lotion form is typically applied to the skin to help protect against sun exposure. The product is formulated at a concentration of 150 mg per gram of lotion.

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 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 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII U182GP2CF3
    Bromelain is an enzyme derived from pineapple plants that breaks down proteins. In medications, it acts as a disintegrant, helping tablets or capsules break apart and release their active ingredients more quickly in the digestive system.
  • UNII NFX970DSI2
    A silicone-based lubricant made from long-chain alkyl groups attached to silicone. It reduces friction and helps the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 6DWD51M0O8
    A synthetic oil made from long-chain hydrocarbons derived from petroleum. It acts as a lubricant and glidant to help powder particles flow smoothly during tablet manufacturing and packaging.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII A626UU0W2A
    Glyceryl monobehenate is a waxy substance made from glycerin and behenic acid. It's used as a binder and lubricant to help hold tablet ingredients together and improve how smoothly the medicine flows during manufacturing.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII WB5K9Y35Y9
    A synthetic crosslinked polymer made by combining hexamethylene diisocyanate with trimethylol hexyllactone. It's used as a film-former and binder to help create protective coatings on tablets or capsules and improve product stability.
  • UNII W60VYE24XC
    A synthetic oily compound used as an emollient and solvent in topical medicines. It helps soften the skin, improve product spreadability, and dissolve active ingredients for better absorption through the skin.
  • UNII S4V5BS6GCX
    A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII A236A06Y32
    Papain is an enzyme derived from papaya fruit. In medicines, it works as a proteolytic agent to help break down proteins and improve the dissolving or absorption of active ingredients in the formulation.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 78GX033D7I
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles and helps powder ingredients flow smoothly during manufacturing and tablet formation.

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

The official label also statesAllantoin, Bromelain, C12-15 Alkyl Benzoate, C30-45 Alkyl Methicone, C30-45 Olefin, Camellia Sinensis (Green Tea) Polyphenols, Dimethicone, Glyceryl Behenate, HDI/Trimethylol Hexyllactone Crosspolymer, Isodecyl Neopentanoate, Isononyl Isononanoate, Isostearic Acid, Papain, Phenoxyethanol, Phenyl Trimethicone, Polyhydroxystearic Acid, Silica, Tocopherol, Trimethylsiloxysilicate.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mineral Repair SPF 45 150 mg/gthis 51326-0245-01 Topiderm, 30 g — — FDA listed —
TiZO Tinted Moisturizing Serum - Light 150 mg/g 58892-0131-50 Fallien 1 tube — — FDA listed —
TiZO Tinted Moisturizing Serum - Medium-Deep 150 mg/g 58892-0134-50 Fallien 1 tube — — FDA listed —
Impeccable Skin - Sand 150 mg/g 69949-0153-01 Synchronicity 56.7 g — — FDA listed —
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30 150 mg/g 79265-5708-01 Babo 17 g — — FDA listed —
Impeccable Skin - Mocha 150 mg/g 69949-0157-01 Synchronicity 56.7 g — — FDA listed —
Laspa Tinted Matte Sunscreen Spf 20 Light 150 mg/g 71780-0520-50 The 1 tube — — FDA listed —
Impeccable Skin - Ivory 150 mg/g 69949-0151-01 Synchronicity 56.7 g — — FDA listed —
TiZO Tinted Moisturizing Serum - Light-Medium 150 mg/g 58892-0132-50 Fallien 1 tube — — FDA listed —
Impeccable Skin - Tan 150 mg/g 69949-0154-01 Synchronicity 56.7 g — — FDA listed —
TiZO Tinted Moisturizing Serum - Medium 150 mg/g 58892-0133-50 Fallien 1 tube — — FDA listed —
TiZO Tinted Moisturizing Serum - Deep 150 mg/g 58892-0135-50 Fallien 1 tube — — FDA listed —
Impeccable Skin - Buff 150 mg/g 69949-0152-01 Synchronicity 56.7 g — — FDA listed —
SPF 30 - Zinc Oxide Lip Balm 150 mg/g 63645-0184-01 OraLabs 4 g — — FDA listed —
Impeccable Skin - Nude 150 mg/g 69949-0156-01 Synchronicity 56.7 g — — FDA listed —
SPF 30 - Zinc Oxide Lip Balm 150 mg/g 54414-0107-01 Dermatone 4.2 g — — FDA listed —
Impeccable Skin - Bronze 150 mg/g 69949-0155-01 Synchronicity 56.7 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 years 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 Zinc oxide — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation257

Reporter sex

0 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Death290
Disabling63
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 365 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
51326-0245-01 You're viewing this 30 g in 1 BOTTLE, PUMP (51326-245-01) 2022-05-07 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 51326-245-01, 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: 51326-0245-01, written without dashes as 51326024501. 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 51326-0245-01, the first segment (51326) is the labeler code FDA assigned to Topiderm, Inc.; the middle segment (0245) 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 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.

📄 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 30 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 93 words ▾

Directions Apply liberally before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor. 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 of 15 or higher and other sunscreen measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses

⚠️ Warnings 56 words ▾

Warnings For external use only. When using this product keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Oxide 15%

🧪 Inactive Ingredients 38 words ▾

Inactive ingredients Allantoin, Bromelain, C12-15 Alkyl Benzoate, C30-45 Alkyl Methicone, C30-45 Olefin, Camellia Sinensis (Green Tea) Polyphenols, Dimethicone, Glyceryl Behenate, HDI/Trimethylol Hexyllactone Crosspolymer, Isodecyl Neopentanoate, Isononyl Isononanoate, Isostearic Acid, Papain, Phenoxyethanol, Phenyl Trimethicone, Polyhydroxystearic Acid, Silica, Tocopherol, Trimethylsiloxysilicate.

🎯 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 ↗
← 51326-0220-01 · Topiderm, 51326-0307-01 · Topiderm, →
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.