Home › NDC Lookup › Ingredients › Zinc Oxide › 83657-0610-08
Sheer Protection SPF 30 Zinc Oxide .0135 g/g Cream, 7.5 g — NDC 83657-0610-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sheer Protection SPF 30 Zinc Oxide .0135 g/g Cream, 7.5 g — NDC 83657-610-08 (Billing 83657-0610-08)

by Skin Script, LLC · 7.5 g in 1 JAR

This is a package of 7.5 g of Sheer Protection SPF 30 Zinc Oxide .0135 g/g Cream from Skin Script, LLC, no longer marketed (first marketed Sep 2023), no longer in the FDA NDC Directory.

NDC 83657-0610-08
🏷️ FDA NDC (as labeled) 83657-610-08 billing pads the product segment with a zero
This package
Contains7.5 g Pack sizes3 compare ↓
Product page 83657-0610-03 Also comes in: 7 g 83657-610-63 60 g 83657-610-03
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 83657-610-08 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83657 labeler · 610 product · 08 package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8365761008 3
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83657-610-08
Product NDC 83657-610
11-digit billing NDC 83657061008
UNII SOI2LOH54Z
Application # M020
SPL Set ID 0450dcc9-3f8f-e2c2-e063-6294a90af60b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2023-09-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83657-610-08 — 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 → 83657-0610-08. 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?

Sheer Protection SPF 30 is an over-the-counter sunscreen cream applied to the skin. It contains zinc oxide, a mineral ingredient that functions as a physical sunscreen by reflecting and scattering ultraviolet rays from the sun. Zinc oxide products in this category are commonly used to help protect skin from sun exposure and are marketed under the FDA's established rules for over-the-counter sunscreens.

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.
Try another pack size: 7 g 60 g
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
83657-0610-03 83657-610-03 Main listing 60 g in 1 TUBE 2012-01-01 — Active
83657-0610-08 You're viewing this 7.5 g in 1 JAR 2012-01-01 — Discontinued by firm
83657-0610-63 83657-610-63 7 g in 1 TUBE 2012-01-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 7.5 g — 7.5 g in 1 jar.
How does this package differ from NDC 83657-0610-63?
Both are Sheer Protection SPF 30 Zinc Oxide .0135 g/g Cream — the drug itself is identical. This page's package is the 7.5 g one, while NDC 83657-0610-63 is the 7 g package.
What NDC number is used to bill for this package of Sheer Protection SPF 30 Zinc Oxide .0135 g/g Cream?
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
Sheer Protection SPF 30 .0135 g/gthis 83657-0610-08 Skin 7.5 g — — Discontinued —
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
Sep 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 A7E6112E4N
    A form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down, helping maintain stability and shelf life.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5PWM7YLI7R
    Barley is a grain plant. It may be used in some medicines as a filler or binder to add bulk and help hold the tablet or capsule together.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • 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.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • UNII BDZ3DQM98W
    Ergothioneine is a naturally occurring compound found in mushrooms and some bacteria. It's used in medicines as an antioxidant to help protect the product from degradation during storage.
  • UNII ANA2NCS6V1
    A natural oil derived from macadamia nuts, used as an emollient and conditioning agent. It helps soften the product's texture and improve how it spreads or absorbs on skin or mucous membranes.
  • UNII 7IGF0S7R8I
    Phytic acid is a naturally occurring compound found in plants that acts as a chelating agent and preservative in medicines. It helps stabilize formulations and prevent oxidation of active ingredients.
  • 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 HYE7O27HAO
    Glyceryl isostearate is a fatty substance derived from vegetable oils or animal fats. In medicines, it acts as an emulsifier to blend water and oil components together, and helps form a smooth texture in creams, ointments, and other topical products.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII NT00Y05A2V
    A liquid extract from witch hazel plant leaves and twigs. It's used in topical products as an astringent agent and to help deliver other active ingredients into the skin.
  • UNII YCZ8EM144Q
    A fat derived from palm oil that has been chemically treated to make it more stable. It acts as a binder and lubricant in tablets and capsules, helping hold ingredients together and prevent sticking during manufacturing.
  • UNII 9M44R3409A
    A modified corn starch where some starch molecules have hydroxypropyl groups attached. It's used as a binder and disintegrant to help hold tablet ingredients together and allow the tablet to break apart properly when swallowed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII W60VYE24XC
    A synthetic oily compound used as an emollient and solvent in topical medicines. It helps soften the skin, improve product spreadability, and dissolve active ingredients for better absorption through the skin.
  • 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 5N1WD9784U
    A plant-derived ingredient from honeysuckle flowers, used as a natural flavoring or fragrance component to improve taste or aroma in the medicine.
  • UNII 4465L2WS4Y
    A plant extract from Japanese honeysuckle flowers used as a natural flavoring and fragrance ingredient in medicines. It may also help preserve the product and add pleasant taste or aroma.
  • 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 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 PBG27B754G
    Phellodendron amurense bark is a plant-derived ingredient from the cork tree. It functions as a natural preservative and antimicrobial agent to help maintain product stability and prevent microbial growth.
  • UNII 4A0NCJ6RD6
    Polyglycerin-3 is a synthetic ingredient made by linking multiple glycerin molecules together. It acts as an emulsifier and humectant, helping oils and water mix smoothly and keeping the product from drying out.
  • UNII PMX5872701
    A waxy, plant-derived substance made from glycerin and stearic acid. It acts as an emulsifier and thickener in medicines, helping blend oil and water ingredients together and creating the right texture.
  • 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 14AN0J70WO
    A red seaweed extract used as a natural binder and thickener in medications. It helps hold tablet ingredients together and may improve the texture of liquid formulations.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • UNII R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • UNII 3641YW25N2
    A fragrant oil extracted from sandalwood tree wood, used as a flavoring agent and fragrance to improve the taste and smell of medicines.
  • UNII 47X6Y9FJJ2
    A natural plant-derived wax extracted from jojoba seeds. It acts as a coating agent, emollient, and consistency modifier to improve texture and help the medicine maintain its form.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
  • UNII IN99IT31LN
    Sodium stearoyl lactylate is a synthetic compound made from stearic acid and lactic acid. It works as an emulsifier to help keep oils and water mixed together, and as a dough conditioner in solid dosage forms.
  • 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.

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

The official label also statesInactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Glyceryl Isostearate, Cetearyl Alcohol, Porphyra Umbilicalis (Red Algae) Extract, Macadamia Ternifolia Seed Oil, Bisabolol (L-alpha), Phellodendron Amurense Bark Extract, Tocopheryl Acetate (D-alpha), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Santalum Album (Sandalwood) Extract, Sodium Stearoyl Lactylate, Alcohol, Polyglyceryl-10 Pentastearate, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Lecithin, Phytic Acid, Hydrogenated Palm Glycerides, Sodium Lactate, Sodium Hydroxide, Citric Acid

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

LabelerSkin Script, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83657
First marketedSep 2023
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from Skin Script, LLC labeler code 83657

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses: Helps prevent sunburn If used as directed with other protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 89 words ▾

Directions: Apply liberally 15 min before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours Children under 6 months: 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm.

Wear long sleeve shirts, pants, hats, and sunglasses.

⚠️ Warnings 57 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 the product is swallowed, get medical help or contact a Posion Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient(s): Zinc Oxide (13.5%)

🧪 Inactive Ingredients 98 words ▾

Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Glyceryl Isostearate, Cetearyl Alcohol, Porphyra Umbilicalis (Red Algae) Extract, Macadamia Ternifolia Seed Oil, Bisabolol (L-alpha), Phellodendron Amurense Bark Extract, Tocopheryl Acetate (D-alpha), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Santalum Album (Sandalwood) Extract, Sodium Stearoyl Lactylate, Alcohol, Polyglyceryl-10 Pentastearate, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Lecithin, Phytic Acid, Hydrogenated Palm Glycerides, Sodium Lactate, Sodium Hydroxide, Citric Acid

🎯 Purpose 2 words ▾

Purpose: Sunscreen

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. If the product is swallowed, get medical help or contact a Posion Control center right away.

📄 Other Information 11 words ▾

Other Information: Protect the product from excessive heat and direct sun.

📄 Package Label / Principal Display Panel 4 words ▾

Sheer Protection SPF 2oz

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 7 g (83657-0610-63), 60 g (83657-0610-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Skin Script, LLC 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.
← 83657-0600-01 · Skin 83659-0111-01 · Jilin →
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.