SkinSuit TM 3 in 1 Moisturizer SPF 50 ZINC OXIDE 175 mg/mL Cream, 177 mL
by Skin Authority LLC · 177 mL in 1 BOTTLE (46007-849-06)
NDC 46007-0849-06
🏷️ FDA NDC (as labeled)
46007-849-06
billing pads the product segment with a zero
This package
Contains177 mL
Pack sizes2 compare ↓
Also comes in:
90 ml 46007-0849-03
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 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)
46007-849-06
Product NDC
46007-849
11-digit billing NDC
46007084906
UNII
SOI2LOH54Z
UPC
0811006022510, 0811006022503
Application #
M020
SPL Set ID
5eb27be9-9e80-4f4a-b193-b918d831555d
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
2025-08-26
Route
TOPICAL
Dosage form
CREAM
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 46007-849-06 — 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 → 46007-0849-06. 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
LabelerSkin Authority LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code46007
First marketedAug 2025
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?
SkinSuit TM 3 in 1 Moisturizer SPF 50 is a topical cream containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter commonly used in sunscreen products to help protect skin from ultraviolet rays. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness standards for sunscreen ingredients rather than undergoing individual product review.
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.
-
UNII 77MKL7AR5I
A natural oil extracted from baobab tree seeds. It's used as an emollient and skin-conditioning agent to help soften the product texture and improve how the medicine feels on application.
-
UNII RUE8E6T4NB
Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
-
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 253RUG1X1A
A natural flavoring and coloring agent derived from blueberry fruit. It adds taste and blue-purple color to the medicine while serving no therapeutic purpose.
-
UNII A9EJ3J61HQ
A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
-
UNII 09FUA47KNA
Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
-
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 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 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.
-
UNII 9M6AAX381U
A plant extract from carrot seeds used as a natural flavoring, coloring, or aromatic agent in medications. It may also provide antioxidant properties to help preserve the product's stability.
-
UNII Z17H97EA6Y
A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
-
UNII 11A386X1QH
Dodecane is a clear, colorless liquid hydrocarbon derived from petroleum. It functions as a solvent and lubricant in medicines, helping dissolve active ingredients and improve how the product flows during manufacturing.
-
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 TM2TZD4G4A
A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
-
UNII W2ZU1RY8B0
A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
-
UNII 4OXD9M35X2
A natural fat extracted from mango seeds, used as an emollient and binder to soften the medicine and help hold ingredients together in creams, lotions, and solid formulations.
-
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 56687D1Z4D
A natural plant extract from pomegranate fruit, used as a flavor and color ingredient to enhance taste and appearance in medicines.
-
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.
-
UNII 65UEH262IS
Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
-
UNII K49155WL9Y
Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
-
UNII 65A9F4P024
A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
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 AZQ08K38Z1
A synthetic oily liquid derived from salicylic acid. It works as an emollient and penetration enhancer in topical formulations, helping active ingredients absorb into skin while conditioning and softening the application area.
-
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.
28 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesAdansonia Digitata Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Propanediol, Punica Granatum Fruit Extract, Sodium Stearoyl Glutamate, Stearic Acid, Tocopherol, Tridecyl Salicylate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water (Aqua), Xanthan Gum.
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 g | 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.
Try another pack size:
90 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.
🔁 Therapeutic equivalents
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
Aug 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.
🔬 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 SkinSuit TM 3 in 1 Moisturizer SPF 50 (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 |
|---|---|---|---|
| 46007-0849-03 | 90 mL in 1 TUBE (46007-849-03) | 2025-08-26 | Active |
| 46007-0849-06 You're viewing this | 177 mL in 1 BOTTLE (46007-849-06) | 2025-08-26 | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 46007-0849-06?
NDC 46007-0849-06 contains 177 mL — 177 ml in 1 bottle.
What is the difference between NDC 46007-0849-06 and NDC 46007-0849-03?
Both are SkinSuit TM 3 in 1 Moisturizer SPF 50 ZINC OXIDE 175 mg/mL Cream — the drug itself is identical. NDC 46007-0849-06 is the 177 mL package, while NDC 46007-0849-03 is the 90 ml package.
What NDC number is used to bill for this package of SkinSuit TM 3 in 1 Moisturizer SPF 50 ZINC OXIDE 175 mg/mL Cream?
Bill NDC 46007-0849-06 — the 11-digit billing format is 46007084906. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 46007-849-06, 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: 46007-0849-06, written without dashes as 46007084906. 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 46007-0849-06, the first segment (46007) is the labeler code FDA assigned to Skin Authority LLC; the middle segment (0849) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) 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 Skin Authority LLC. 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 1 other package presentation of this same product, including 90 ml (46007-0849-03). 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 Authority 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.
📄 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. higher SPF gives more sunburn protection. retains SPF after 80 minutes of swimming or sweating If used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by sun
⏱️ Dosage and Administration ▾
Directions: Apply liberally 15 minutes before sun exposure and as needed . Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.
⚠️ Warnings ▾
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. Do not store it at temperatures above 120º F. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.
🧪 Active Ingredient ▾
Active Ingredient Zinc Oxide 17.5% Purpose Sunscreen
🧪 Inactive Ingredients ▾
Inactive Ingredients: Adansonia Digitata Oil, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Daucus Carota Sativa (Carrot) Seed Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Caprylate, Glyceryl Stearate SE, Glyceryl Undecylenate, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Propanediol, Punica Granatum Fruit Extract, Sodium Stearoyl Glutamate, Stearic Acid, Tocopherol, Tridecyl Salicylate, Vaccinium Angustifolium (Blueberry) Fruit Extract, Water (Aqua), Xanthan Gum.
🎯 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.