Tri-water sheer mineral sunscreen cushion SPF30 Zinc Oxide 188 mg/g Sponge, 15 g
by Eden Brands Inc. · 1 CONTAINER in 1 CARTON (72113-111-22) / 15 g in 1 CONTAINER
NDC 72113-0111-22
🏷️ FDA NDC (as labeled)
72113-111-22
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)
72113-111-22
Product NDC
72113-111
11-digit billing NDC
72113011122
UNII
SOI2LOH54Z
UPC
0850068719037
Application #
M020
SPL Set ID
2cd22172-78cb-32f3-e063-6394a90a395d
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-12-18
Route
TOPICAL
Dosage form
SPONGE
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 72113-111-22 — 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 → 72113-0111-22. 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
LabelerEden Brands Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code72113
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio6 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 product in sponge form applied to the skin. It contains zinc oxide, a mineral ingredient commonly used in sunscreens to reflect and scatter ultraviolet (UV) light away from the skin. The product is marketed under the FDA's monograph rule for sunscreen drugs, meaning it follows established safety and ingredient standards for over-the-counter sun protection products rather than being individually reviewed by the FDA.
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 TR046Y3K1G
A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII ZY81Z83H0X
Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
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UNII 114P5I43UJ
A hydrocarbon oil derived from petroleum, containing 13 to 15 carbon atoms per molecule. It serves as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
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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.
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UNII UJ10V6YY6H
Chimyl alcohol is a fatty alcohol derived from natural oils or synthetically produced. It functions as an emulsifier and surfactant, helping oil and water mix evenly throughout the medicine.
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UNII 8D9H4QU99H
A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
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UNII AMN6S4M09G
A natural liquid derived from coconut, used as a solvent and hydrating agent in liquid formulations. It helps dissolve or suspend active ingredients and may contribute mild flavor or texture to the medicine.
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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.
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UNII 609A3V1SUA
A silky liquid derived from caprylic acid that acts as an emollient and solvent in formulations. It helps dissolve active ingredients and improves the spreadability and feel of lotions, creams, and topical products.
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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.
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UNII F4O1DKI9A6
A type of algae used as a natural colorant and source of beta-carotene (which gives products an orange-yellow color). It helps color the medication and may provide antioxidant properties to 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.
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UNII 31T0FF0472
A red microalgae used as a natural colorant and source of astaxanthin pigment in medications and supplements. It adds color to tablets and capsules.
-
UNII G1L3HT4CMH
A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
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UNII 91D9GV0Z28
A mineral salt made from calcium and phosphate. It acts as a filler to add bulk to the tablet or capsule, and helps bind ingredients together so the medicine holds its shape.
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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.
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UNII 62160PU6FJ
A natural oil derived from caraway seeds, used as a flavoring agent and solvent to improve taste and help dissolve or mix other ingredients in the medicine.
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UNII 113171Q70B
Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
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UNII 5M609NV974
A plant extract from magnolia bark used as a natural flavoring agent and preservative in medicines. It may help mask bitter tastes and protect the product from spoilage.
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UNII N7TD9J649B
A bitter compound naturally found in citrus fruits, naringin is used as a flavoring agent and taste modifier in medicines to mask unpleasant drug flavors and improve palatability.
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UNII 15B05TY4GX
A synthetic emulsifier derived from glycerin and oleic acid. It helps blend oil and water-based ingredients together in cosmetics and medicines, creating uniform, stable formulations.
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UNII G4AYJ54K59
A plant-derived emulsifier made from glycerin and oleic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the product's shelf life.
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UNII YPM0ZOC2HR
A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
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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.
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UNII C2BRV53B1V
A plant-derived oil from pongamia seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product texture while improving how it spreads on skin.
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UNII SMD1X3XO9M
Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
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UNII 5965N8W85T
Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
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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.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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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.
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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.
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UNII YA22H34H9Q
A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade the medicine.
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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.
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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.
34 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater (Aqua), Glycerin, Isoamyl Laurate, Silica, Caprylic/Capric Triglyceride, Dimethicone, C13-15 Alkane, Squalane, Hydroxyapatite, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Propanediol, Cellulose, Polyglyceryl-4 Oleate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, 1,2-Hexanediol, Polyglyceryl-6 Oleate, Coco-Caprylate/Caprate, Maris Limus Extract, Pongamia Glabra Seed Oil, Lauroyl Lysine, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cucumis Sativus (Cucumber) Fruit Extract, Chimyl Alcohol, Magnolia Officinalis Bark Extract, Pongamia Pinnata Seed Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Tocopherol, Naringin
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 each | 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 |
|---|---|---|---|---|---|---|
| Ultra sheer mineral sunscreen PRO SPF30 188 mg/g 72113-0112-14 | Eden | 1 bottle | — | — | FDA listed | — |
| Tri-water sheer mineral sunscreen cushion SPF30 188 mg/gthis 72113-0111-22 | Eden | 15 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
🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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 Tri-water sheer mineral sunscreen cushion SPF30 (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
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 |
|---|---|---|---|
| 72113-0111-22 You're viewing this | 1 CONTAINER in 1 CARTON (72113-111-22) / 15 g in 1 CONTAINER | 2024-12-18 | 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 72113-111-22, 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: 72113-0111-22, written without dashes as 72113011122. 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 72113-0111-22, the first segment (72113) is the labeler code FDA assigned to Eden Brands Inc.; the middle segment (0111) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (22) 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 Eden Brands Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eden Brands 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 ▾
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 ▾
DIRECTIONS: • Apply liberally to face and body 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months of age: ask 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 value of 15 or higher and other sun protection measures including: • Limit your time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.
⚠️ 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.
🧪 Active Ingredient ▾
ACTIVE INGREDIENT: Zinc Oxide 18.8%
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS: Water (Aqua), Glycerin, Isoamyl Laurate, Silica, Caprylic/Capric Triglyceride, Dimethicone, C13-15 Alkane, Squalane, Hydroxyapatite, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Propanediol, Cellulose, Polyglyceryl-4 Oleate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, 1,2-Hexanediol, Polyglyceryl-6 Oleate, Coco-Caprylate/Caprate, Maris Limus Extract, Pongamia Glabra Seed Oil, Lauroyl Lysine, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cucumis Sativus (Cucumber) Fruit Extract, Chimyl Alcohol, Magnolia Officinalis Bark Extract, Pongamia Pinnata Seed Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Tocopherol, Naringin
🎯 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.