Alba Botanica Sheer Mineral SPF30 Zinc Oxide 24.1 g/100g Lotion, 59 g
by The Hain Celestial Group, Inc. · 59 g in 1 TUBE (61995-2033-1)
NDC 61995-2033-01
🏷️ FDA NDC (as labeled)
61995-2033-1
billing pads the package segment with a zero
This package
Contains59 g
Pack sizes3 compare ↓
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 →
⚠️
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)
61995-2033-1
Product NDC
61995-2033
11-digit billing NDC
61995203301
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
0cf9361f-f292-6429-e063-6294a90add0e
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-01-01
Route
TOPICAL
Dosage form
LOTION
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 61995-2033-1 — a 5-4-1 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 package segment → 61995-2033-01. 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 Hain Celestial Group, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61995
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio12 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 topical sunscreen lotion containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter that is typically used in sunscreen products to help protect skin from ultraviolet (UV) radiation by reflecting and scattering UV rays away from the skin. The product is marketed as an over-the-counter monograph drug, which means it is formulated according to FDA's established rules for sunscreen ingredients and strengths rather than as an individually approved application.
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.
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 9E8X80D2L0
A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
-
UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
-
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 DI775RT244
A natural fatty acid derived from coconut or palm oil. Used as an emulsifier and solubilizer to help mix oil and water components and improve how the medicine dissolves and absorbs in the body.
-
UNII R34927QY59
A synthetic oil derived from oleic acid and ethylhexyl alcohol. It acts as an emollient and solvent in topical formulations, helping active ingredients dissolve and spread smoothly on skin.
-
UNII 147D247K3P
Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
-
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 FCZ5MH785I
A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
-
UNII ZBX50UG81V
A salt derived from phytic acid, a natural compound found in plants. In medications, it functions as a chelating agent and buffering substance, helping to stabilize formulations and control pH levels.
-
UNII M1SLX00M3M
Isoamyl laurate is a synthetic ester made from isoamyl alcohol and lauric acid. It functions as an emollient and lubricant in topical formulations to help smooth and soften the skin.
-
UNII 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
-
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 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 03KCY6P7UT
A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
-
UNII GW89575KF9
Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
-
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.
-
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.
-
UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
18 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Olivate, Butyloctyl Salicylate, Isoamyl Laurate, Glyceryl Stearate SE, Niacinamide, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Tocopheryl Acetate, Glycerin, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Sodium Phytate, Squalane, Xanthan Gum, Alcohol (1), Ethylhexylglycerin, Phenoxyethanol (1) Certified Organic Ingredient
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 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
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Alba Botanica Sheer Mineral SPF50 24.1 g/100g 61995-2035-01 | The | 59 g | — | — | FDA listed | — |
| Alba Botanica Sensitive Mineral SPF 50 24.1 g/100g 61995-2036-01 | The | 59 g | — | — | FDA listed | — |
| Alba Botanica Sheer Mineral SPF30 24.1 g/100gthis 61995-2033-01 | The | 59 g | — | — | FDA listed | — |
| Alba Botanica Sensitive Mineral SPF 30 24.1 g/100g 61995-2034-01 | The | 59 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
Jan 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
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61995-2033-01 You're viewing this | 59 g in 1 TUBE (61995-2033-1) | 2022-01-01 | Active |
| 61995-2033-02 | 89 g in 1 TUBE (61995-2033-2) | 2022-01-01 | Active |
| 61995-2033-03 | 113 g in 1 TUBE (61995-2033-3) | 2022-01-01 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 61995-2033-01?
NDC 61995-2033-01 contains 59 g — 59 g in 1 tube.
What is the difference between NDC 61995-2033-01 and NDC 61995-2033-02?
Both are Alba Botanica Sheer Mineral SPF30 Zinc Oxide 24.1 g/100g Lotion — the drug itself is identical. NDC 61995-2033-01 is the 59 g package, while NDC 61995-2033-02 is the 89 g package.
What NDC number is used to bill for this package of Alba Botanica Sheer Mineral SPF30 Zinc Oxide 24.1 g/100g Lotion?
Bill NDC 61995-2033-01 — the 11-digit billing format is 61995203301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 61995-2033-1, 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: 61995-2033-01, written without dashes as 61995203301. 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 61995-2033-01, the first segment (61995) is the labeler code FDA assigned to The Hain Celestial Group, Inc.; the middle segment (2033) 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 Hain Celestial Group, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 89 g (61995-2033-02), 113 g (61995-2033-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
The Hain Celestial Group, 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 ▾
Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.
⏱️ Dosage and Administration ▾
Apply liberally 15 minutes before sun exposure. Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours. Children under 6 months of age: ask a doctor.
⚠️ 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 skin rash occurs.
🧪 Active Ingredient ▾
Zinc Oxide 24.1% (w/w)
🧪 Inactive Ingredients ▾
Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Olivate, Butyloctyl Salicylate, Isoamyl Laurate, Glyceryl Stearate SE, Niacinamide, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Tocopheryl Acetate, Glycerin, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Sodium Phytate, Squalane, Xanthan Gum, Alcohol (1), Ethylhexylglycerin, Phenoxyethanol (1) Certified Organic Ingredient
🎯 Purpose ▾
Sunscreen
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 ↗
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.