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Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light ZINC OXIDE 175 mg/mL Cream — NDC 82328-0013-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light ZINC OXIDE 175 mg/mL Cream — NDC 82328-0013-1 (Billing 82328-0013-01)

by REJUVA MINERALS INC · 1 BOTTLE, PUMP in 1 CARTON / 50 mL in 1 BOTTLE, PUMP

This is a package of Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light ZINC OXIDE 175 mg/mL Cream from REJUVA MINERALS INC, marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.

NDC 82328-0013-01
🏷️ FDA NDC (as labeled) 82328-0013-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 82328-0013-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82328 labeler · 0013 product · 1 package
Package marketed since
Jan 2, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0767550468932
FDA record last changed
Jul 24, 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) 82328-0013-1
Product NDC 82328-0013
11-digit billing NDC 82328001301
UNII SOI2LOH54Z
UPC 0767550468932
Application # M020
SPL Set ID 2abccc86-01d4-e45c-e063-6294a90a7f8b
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-02
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 82328-0013-1 — 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 → 82328-0013-01. 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.

Clinical

🧪 What is this product?

This is a tinted mineral sunscreen cream applied to the face to help protect skin from sun damage. It contains zinc oxide, a physical UV filter that reflects and scatters ultraviolet rays from the sun. The product is marketed as an over-the-counter drug under FDA's monograph rules for sunscreen products and carries an SPF rating of 16.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82328-0013-01 You're viewing this Main listing 1 BOTTLE, PUMP in 1 CARTON / 50 mL in 1 BOTTLE, PUMP 2025-01-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Valmont Daily Veil. Moisturizing Face Fluid Mineral Sunscreen 175 mg/mL 73284-0508-00 Innovation 1 bottle — — FDA listed —
Proven Personalized Day Moisturizer Sunscreen SPF 30 175 mg/mL 73572-0008-01 Proven 30 ml — — FDA listed —
YAYA Organics SPF-50 Baby Kids Mineral Sunscreen 175 mg/mL 82526-0268-00 YAYA 89 ml — — FDA listed —
SkinSuit TM 3 in 1 Moisturizer SPF 50 175 mg/mL 46007-0849-03 Skin 90 ml — — FDA listed —
KLARINA Sheer Mineral Sunscreen Blender SPF 50 175 mg/mL 85928-0625-00 KLARINA 1 bottle — — FDA listed —
Venture Performance Sun Protection Mineral Sunscreen SPF 50 175 mg/mL 87241-0911-00 Venture 100 ml — — FDA listed —
Solvyn Mineral Sunscreen SPF 50 175 mg/mL 87777-0948-00 Solvyn 5 ml — — FDA listed —
Kiss My Face Purely Mineral Face Factor 50 Sunscreen SPF 50 175 mg/mL 74154-0902-00 Windmill 100 ml — — FDA listed —
HygieneLab Face and Body Mineral Sunscreen SPF 50 175 mg/mL 87116-0879-00 HYGIENELAB, 1 tube — — FDA listed —
Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50 175 mg/mL 74154-0903-00 Windmill 118 ml — — FDA listed —
Pool Bar London Not Just a Pretty Face Sunscreen SPF 50 175 mg/mL 84953-0565-00 POOLBAR 1 tube — — FDA listed —
Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16 175 mg/mL 82328-0012-01 REJUVA 1 bottle — — FDA listed —
Amrit Ocean Resort Mineral Sunscreen SPF 50 175 mg/mL 87777-0947-00 Solvyn 5 ml — — FDA listed —
Valmont Daily Veil Moisturizing Face Fluid Mineral Sunscreen SPF 30 175 mg/mL 83883-0001-00 CVL 1 tube — — FDA listed —
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50 175 mg/mL 85750-0611-00 LIKE 1 tube — — FDA listed —
Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light 175 mg/mLthis 82328-0013-01 REJUVA 1 bottle — — FDA listed —
YAYA Organics SPF-50 Sports Cream 175 mg/mL 82526-0269-00 YAYA 89 ml — — FDA listed —
Stellar Mineral Glow Guard Sunscreen Broad Spectrum SPF 50 175 mg/mL 87673-0960-00 Stellar 1 bottle — — FDA listed —
Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Medium Tan 175 mg/mL 82328-0014-01 REJUVA 1 bottle — — FDA listed —
Sunscreen In the Raw SPF 50 175 mg/mL 82177-0004-00 Biomin 89 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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.

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 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.
  • UNII SQE6VB453K
    A calcium salt derived from gluconic acid. It acts as a buffer and mineral supplement in formulations, helping maintain stable pH and adding nutritional calcium content to the product.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • 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 BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 HO4ZT5S86C
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
  • UNII Q41S464P1R
    A synthetic peptide (short protein-like molecule) used in skincare and cosmetic formulations as an active conditioning ingredient to help improve skin texture and appearance. It may function as a humectant or skin-conditioning agent in topical products.
  • UNII MPJ2Q8WI8G
    A plant-derived emulsifier made from glycerin and lauric acid. It helps mix oil and water-based ingredients together and improves product texture and stability in formulations.
  • 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 D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII X7X01WMQ5F
    A fragrant oil derived from sandalwood trees, used primarily as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII NVZ4I0H58X
    A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.
  • 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.

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

The official label also statesWater (Aqua), Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Oil, Sorbitan Stearate, Polyglyceryl-10 Laurate, Ricinus Communis (Castor) Seed Oil, Glycerin*, Titanium Dioxide CI 77891, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Magnesium Sulfate, Gluconolactone, Triethoxycaprylylsilane, Iron Oxide CI 77492, Sodium Benzoate, Santalum Album (Sandalwood) Oil, Xanthan Gum, Iron Oxide CI 77491, Simmondsia Chinensis (Jojoba) Seed Oil*, Cocos Nucifera (Virgin Coconut) Oil*, Iron Oxide CI 77499, Calcium Gluconate, Sodium Hyaluronate, Palmitoyl Tetrapeptide-7, Palmitoyl Hexapeptide-12. *Certified Organic.

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.

Manufacturer & labeler

LabelerREJUVA MINERALS INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code82328
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from REJUVA MINERALS INC labeler code 82328

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 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 📄 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 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 90 words ▾

Directions: Apply liberally 15 minutes before sun exposure Reapply 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. – 2p.m. Wear long-sleeved shirts, pants, hats, and sunglasses use water resistant sunscreen if swimming or sweating Children under 6 months of age: Ask a doctor.

⚠️ Warnings 54 words ▾

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 rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words ▾

Active Ingredients Zinc Oxide (17.5%) Purpose Sunscreen

🧪 Inactive Ingredients 78 words ▾

Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Oil, Sorbitan Stearate, Polyglyceryl-10 Laurate, Ricinus Communis (Castor) Seed Oil, Glycerin*, Titanium Dioxide CI 77891, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Magnesium Sulfate, Gluconolactone, Triethoxycaprylylsilane, Iron Oxide CI 77492, Sodium Benzoate, Santalum Album (Sandalwood) Oil, Xanthan Gum, Iron Oxide CI 77491, Simmondsia Chinensis (Jojoba) Seed Oil*, Cocos Nucifera (Virgin Coconut) Oil*, Iron Oxide CI 77499, Calcium Gluconate, Sodium Hyaluronate, Palmitoyl Tetrapeptide-7, Palmitoyl Hexapeptide-12. *Certified Organic.

🎯 Purpose 2 words ▾

Purpose Sunscreen

📄 Do Not Use 8 words ▾

Do not use on damaged or broken skin

📄 When Using This Product 13 words ▾

When using this product keep out of eyes. Rinse with water to remove

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if rash occurs

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions: Call (352) 589-0139

📄 Package Label / Principal Display Panel 65 words ▾

Package Labeling: Rejuva Minerals Tinted DAILY WEAR Face Protection SPF 16 Broad Spectrum UVA and UVB Protection Zinc Oxide Firming Peptides and Hyaluronate Acid FAIR-LIGHT 50 ml (1.69 oz) Carton Artwork

Package Labeling: Rejuva Minerals Tinted DAILY WEAR Face Protection SPF 16 Broad Spectrum UVA and UVB Protection Zinc Oxide Firming Peptides and Hyaluronate Acid MEDIUM-TAN 50 ml (1.69 oz) Rejuva Minerals Medium Tan Box

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 Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

0 reports

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 120 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.

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 REJUVA MINERALS INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REJUVA MINERALS 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.
← 82328-0012-01 · REJUVA 82328-0014-01 · REJUVA →
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.