Home › NDC Lookup › Ingredients › Zinc Oxide › 73665-0102-31
KARI GRAN ESSENTIAL SPF SPF 30 ZINC OXIDE 18 g/100mL Solution — NDC 73665-0102-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

KARI GRAN ESSENTIAL SPF SPF 30 ZINC OXIDE 18 g/100mL Solution — NDC 73665-102-31 (Billing 73665-0102-31)

by KARI GRAN · 1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE

This is a package of KARI GRAN ESSENTIAL SPF SPF 30 ZINC OXIDE 18 g/100mL Solution from KARI GRAN, marketed since Oct 2023 and currently FDA-listed.

NDC 73665-0102-31
🏷️ FDA NDC (as labeled) 73665-102-31 billing pads the product segment with a zero
This package
Contains30 mL in 1 bottle Pack sizes3 compare ↓
Product page 73665-0102-15 Also comes in: 50 mL 73665-102-51 15 ml 73665-102-15
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

⚠️
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) 73665-102-31
Product NDC 73665-102
11-digit billing NDC 73665010231
UNII SOI2LOH54Z
Application # M020
SPL Set ID caf07d84-d3f3-eef2-e053-2a95a90aa511
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 2023-10-16
Route TOPICAL
Dosage form SOLUTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 73665-102-31 — 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 → 73665-0102-31. 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?

Kari Gran Essential SPF 30 is a topical solution containing zinc oxide, an inorganic sun-protective ingredient. This product is marketed as an over-the-counter monograph sunscreen, meaning it follows FDA's established rules for sunscreen products rather than being individually reviewed. Zinc oxide is commonly used in sunscreens to reflect and scatter ultraviolet (UV) rays from the sun.

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 mLPer 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.
Try another pack size: 50 mL 15 ml
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
73665-0102-15 73665-102-15 Main listing 15 mL in 1 BOTTLE 2023-10-16 — Active
73665-0102-31 You're viewing this 1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE 2023-10-16 — Active
73665-0102-51 73665-102-51 1 BOTTLE in 1 BOX / 50 mL in 1 BOTTLE 2023-10-16 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 box / 30 ml in 1 bottle.
What NDC number is used to bill for this package of KARI GRAN ESSENTIAL SPF SPF 30 ZINC OXIDE 18 g/100mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kari Gran Essential Spf Spf 30 18 g/100mLthis 73665-0102-31 KARI 1 bottle — — 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

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 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • 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 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 TP11QR7B8R
    A natural oil extracted from kukui nuts, used as an emollient and skin-conditioning agent in topical medicines. It helps soften the formulation and improve how the product spreads and absorbs into skin.
  • UNII 515610SU8C
    Macadamia oil is a plant-derived oil extracted from macadamia nuts. In medicines, it serves as an emollient and solvent to help dissolve or suspend active ingredients and improve product texture and absorption.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII 67EIU8N086
    Plum seed oil is a natural oil extracted from plum kernels. It's used in medicines as an emollient and solvent to help dissolve or carry active ingredients and improve how the product spreads or absorbs.
  • UNII 9S8867952A
    A plant-derived oil from raspberry seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften the product texture and improve skin feel.
  • 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 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.
  • UNII I39WR998BI
    Ultramarine blue is a blue pigment derived from natural minerals or made synthetically. It's used in medicines as a colorant to give tablets, capsules, or other products their blue appearance.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesUNTINTED: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+ TINTED, LIGHT: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, MEDIUM: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, DARK: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica, Ultramarines. *certified organic +non-GMO Vitamin E from Sunflower ++ non-GMO

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

LabelerKARI GRAN
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code73665
First marketedOct 2023
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.

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 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 100 words ▾

DIRECTIONS SHAKE WELL. APPLY AT LEAST 1 PUMP TO FACE. APPLY ADDITIONAL PUMPS TO NECK AND CHEST - AREAS THAT ARE OFTEN IGNORED.

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY 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 BETWEEN 10 A.M.

AND 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES CHILDREN UNDER 6 MONTHS: CONSULT A PHYSICIAN

⚠️ Warnings 35 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.

📦 Storage and Handling 10 words ▾

KEEP THIS PRODUCT AWAY FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT

🧪 Active Ingredient 6 words ▾

ACTIVE INGREDIENT NON-NANO ZINC OXIDE 18%

🧪 Inactive Ingredients 170 words ▾

INACTIVE INGREDIENTS UNTINTED: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+ TINTED, LIGHT: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica.

TINTED, MEDIUM: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, DARK: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica, Ultramarines. *certified organic +non-GMO Vitamin E from Sunflower ++ non-GMO

🎯 Purpose 2 words ▾

PURPOSE SUNSCREEN

📄 Keep Out of Reach of Children 21 words ▾

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, SEEK MEDICAL ATTENTION OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

📄 Questions or Comments 14 words ▾

QUESTIONS OR COMMENTS? CALL MONDAY THROUGH FRIDAY, 206-588-1573 (9 A.M. TO 5 P.M. PST)

📄 Package Label / Principal Display Panel 4 words ▾

0-UC_Essential SPF-30 0-Image_Essential SPF-30

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 KARI GRAN ESSENTIAL SPF SPF 30 (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

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Life-threatening116
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 272 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 KARI GRAN. 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 1 bottle (73665-0102-51), 15 ml (73665-0102-15). 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?
KARI GRAN 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.
← 73656-0049-00 · White 73669-0200-01 · Unimed →
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.