100% Pure Yerba Mate MIst SPF 30 Zinc Oxide 120 mg/mL Aerosol, Spray, 96 mL
by Purity Cosmetics · 96 mL in 1 BOTTLE, SPRAY (52667-006-96)
NDC 52667-0006-96
🏷️ FDA NDC (as labeled)
52667-006-96
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 →
⚠️
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)
52667-006-96
Product NDC
52667-006
11-digit billing NDC
52667000696
UNII
SOI2LOH54Z
UPC
0899738010876
Application #
part352
SPL Set ID
4e7798fb-1b01-62e3-e054-00144ff8d46c
Established class (EPC)
Copper Absorption Inhibitor
Physiologic effect
Decreased Copper Ion Absorption
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-05-01
Route
TOPICAL
Dosage form
AEROSOL, SPRAY
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 52667-006-96 — 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 → 52667-0006-96. 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
LabelerPurity Cosmetics
FDA applicationpart352 (OTC MONOGRAPH NOT FINAL)
Labeler code52667
First marketedMay 2017
Product typeHuman Otc Drug
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 aerosol spray sunscreen marketed under FDA's over-the-counter monograph rules. It contains zinc oxide at 120 mg per milliliter, a mineral ingredient commonly used in sunscreens to reflect and scatter ultraviolet light away from the skin. The product is formulated to provide sun protection at SPF 30 and is applied directly to exposed skin surfaces.
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.
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UNII A3N5ZCN45C
Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
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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 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.
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UNII 00YIU5438U
Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII ICS790225B
A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
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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 W77QUB6GXO
Heptyl undecylenate is a synthetic ester compound used as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth to maintain product stability and safety during storage.
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UNII 1Q953B4O4F
Ilex paraguariensis leaf, commonly known as yerba mate, is a plant extract used in medicines as a flavoring agent and to add botanical content. It may also contribute mild preservative properties to the formulation.
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UNII 7F0EV20QYL
Jojoba oil is a liquid wax extracted from jojoba plant seeds. In medications, it serves as an emollient and carrier oil that helps soften skin, improve texture, and distribute active ingredients evenly in topical formulations.
-
UNII 7666FJ0J9F
A rosin-derived compound used as a film-coating agent and binder in tablets and capsules. It helps create a protective layer around the medication and improves tablet hardness.
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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 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.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesBentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Jojoba Ester, Methyl Dihydroabietate, Water
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 mL | 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| 100% Pure Yerba Mate MIst SPF 30 120 mg/mLthis 52667-0006-96 | Purity | 96 ml | — | — | 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
🏛️
2017
On the market since
May 2017
📍
2026
Currently FDA-listed
9 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 100% Pure Yerba Mate MIst SPF 30 (this brand).
Top reported reactions
Reporter sex
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 |
|---|---|---|---|
| 52667-0006-96 You're viewing this | 96 mL in 1 BOTTLE, SPRAY (52667-006-96) | 2017-05-01 | 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 | ✓ 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 Not Final". 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 52667-006-96, 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: 52667-0006-96, written without dashes as 52667000696. 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 52667-0006-96, the first segment (52667) is the labeler code FDA assigned to Purity Cosmetics; the middle segment (0006) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (96) 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 Purity Cosmetics. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Purity Cosmetics 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.
⏱️ Dosage and Administration ▾
Directions Do not spray directly onto face. Spray into hands and rub onto your face. To ensure adequate sun protection, avoid spreading too thinly when applying.
Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating / immediately after towel drying / at least every 2 hours 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 sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Consult a physician.
⚠️ Warnings ▾
Warnings Contents under pressure. Do not puncture or incinerate. For external use only Do not spray directly on face . Do not use on damaged or broken skin. S top use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.
📦 Storage and Handling ▾
Other information Protect this product from excessive heat and direct sunlight.
🧪 Active Ingredient ▾
Active Ingredients Zinc Oxide 12%
🧪 Inactive Ingredients ▾
Other Ingredients Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Jojoba Ester, Methyl Dihydroabietate, Water
🎯 Purpose ▾
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.