Home › NDC Lookup › Ingredients › Zinc Oxide › 46007-0205-11
Skinsuit Lip Spf 30 Zinc Oxide 10 g/100g Gel, 3.2 g — NDC 46007-0205-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Skinsuit Lip Spf 30 Zinc Oxide 10 g/100g Gel, 3.2 g — NDC 46007-205-11 (Billing 46007-0205-11)

by Skin Authority LLC · 3.2 g in 1 BOTTLE, WITH APPLICATOR

This is a package of 3.2 g of Skinsuit Lip Spf 30 Zinc Oxide 10 g/100g Gel from Skin Authority LLC, marketed since Jan 2020 and currently FDA-listed. It is this product's only package size.

NDC 46007-0205-11
🏷️ FDA NDC (as labeled) 46007-205-11 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 27, 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) 46007-205-11
Product NDC 46007-205
11-digit billing NDC 46007020511
UNII SOI2LOH54Z
Application # M020
SPL Set ID cb24d714-f6cd-4518-b146-627cfe6c2ccd
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 2020-01-02
Route TOPICAL
Dosage form GEL
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 46007-205-11 — 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 → 46007-0205-11. 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?

Skinsuit Lip SPF 30 is a topical gel containing zinc oxide, marketed as an over-the-counter sunscreen product under FDA's monograph rules for sunscreen drugs. Zinc oxide is a mineral sun-blocking agent typically used in lip balms and other products to help protect skin from ultraviolet (UV) radiation. This product is applied directly to the lips and is meant to provide broad-spectrum sun protection with an SPF rating of 30.

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
46007-0205-11 You're viewing this Main listing 3.2 g in 1 BOTTLE, WITH APPLICATOR 2020-01-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ATTITUDE Super leaves Lip Balm SPF 15 Watermelon 10 g/100g 61649-0927-02 9055-7588 2 tubes — — FDA listed —
Skinsuit Lip Spf 30 10 g/100gthis 46007-0205-11 Skin 3.2 g — — FDA listed —
Sun and Honey 10 g/100g 85432-0001-01 Amara 1 tube — — FDA listed —
ATTITUDE Sunly Lip Balm SPF 15 Unscented 10 g/100g 61649-0550-02 9055-7588 2 tubes — — FDA listed —
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen 10 g/100g 61649-0068-01 Attitude 30 g — — FDA listed —
ATTITUDE Sunly Lip Balm SPF 15 Watermelon 10 g/100g 61649-0557-02 9055-7588 2 tubes — — FDA listed —
ATTITUDE Sunly Lip balm Unscented SPF 15 10 g/100g 61649-0093-02 9055-7588 1 tube — — FDA listed —
ATTITUDE Super Leaves Lip Balm SPF15 Unscented 10 g/100g 61649-0920-02 9055-7588 2 tubes — — FDA listed —
Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango 10 g/100g 61649-0983-01 9055-7588 8.5 g — — FDA listed —
DAILY FACE SUNSCREEN Broad Spectrum SPF 30 10 g/100g 81781-0101-50 Lilyana 1 tube — — FDA listed —
ATTITUDE Super leaves Lip Balm SPF 15 Coconut 10 g/100g 61649-0923-02 9055-7588 2 tubes — — FDA listed —
Zinc Oxide Perfecting Sunscreen 10 g/100g 84378-0100-74 Epicuren 74 g — — FDA listed —
ATTITUDE Sunly Lip Balm SPF 15 Coconut 10 g/100g 61649-0553-02 9055-7588 2 tubes — — FDA listed —
ATTITUDE Sunly Lip Balm SPF 15 Pineapple 10 g/100g 61649-0555-02 9055-7588 2 tubes — — FDA listed —
ATTITUDE Super leaves Lip Balm SPF 15 Exotic 10 g/100g 61649-0925-02 9055-7588 2 tubes — — FDA listed —
OLP diaper Rash cream A and D 10 g/100g 80489-0444-01 OL 1 tube — — FDA listed —
Attitude - Lip Balm - SPF 15 - Coconut 10 g/100g 61649-0985-01 Attitude 8.5 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Jan 2020
📍
2026
Currently FDA-listed
6 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 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII Q95M2P1KJL
    A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
  • UNII VY9RTR7MSY
    A silicone-based compound that works as a lubricant and skin-conditioning agent in topical formulations. It helps the product spread smoothly and reduces friction without leaving a heavy residue.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9KB5R958PB
    A silicone-based polymer that forms a protective barrier on skin or mucous membranes. Used in topical formulations as an emollient, water-repellent coating, and skin protectant to reduce moisture loss and irritation.
  • 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 P0TX083987
    A synthetic oil made from hydrogenated plant-derived hydrocarbons, used as a lubricant and glidant to help powder particles flow smoothly during tablet or capsule manufacturing and to prevent sticking.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII 0F897O3O4M
    A naturally occurring alcohol derived from plants or synthesized chemically. It functions as a preservative and flavoring agent in medicines, helping prevent microbial growth and add pleasant taste to oral products.
  • 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 GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • UNII Q3Z4BCH099
    A manufactured wax made from refined petroleum or plant oils. It coats tablet surfaces to control how fast the medicine dissolves and releases, and improves how the tablet feels and looks.
  • 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.

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

The official label also statesHYDROGENATED POLY(C6-14 OLEFIN), SQUALANE, BUTYLOCTYL SALICYLATE, CETEARYL DIMETHICONE, ISODODECANE, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, CAPRYLYL METHICONE, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDE, LECITHIN, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, CAPRYLYL GLYCOL, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, PHENYLPROPANOL, PROPANEDIOL, TIN OXIDE, TITANIUM DIOXIDE (CI 77891), TOCOPHEROL.

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 Authority LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code46007
First marketedJan 2020
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.

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
🎯 Indications and Usage 26 words ▾

USES HELPS PREVENT SUNBURN IF USED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY SUN.

⏱️ Dosage and Administration 39 words ▾

DIRECTIONS APPLY EVENLY TO UPPER AND LOWER LIP 15 MINUTES BEFORE EXPOSURE. NATURAL TINT WILL ABSORB AND BECOME SHEER. REAPPLY EVERY 2 HOURS REAPPLY AS NEEDED AFTER SWIMMING OR PERSPIRING CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

⚠️ Warnings 39 words ▾

WARNINGS FOR EXTERNAL USE ONLY. DO NOT USE ON BROKEN SKIN SERIOUS BURNS WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS

📦 Storage and Handling 19 words ▾

OTHER INFORMATION PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN. STORE AT 40° - 95°F (5° - 35°C).

🧪 Active Ingredient 5 words ▾

ACTIVE INGREDIENT ZINC OXIDE 10%

🧪 Inactive Ingredients 37 words ▾

HYDROGENATED POLY(C6-14 OLEFIN), SQUALANE, BUTYLOCTYL SALICYLATE, CETEARYL DIMETHICONE, ISODODECANE, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, CAPRYLYL METHICONE, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDE, LECITHIN, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, CAPRYLYL GLYCOL, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, PHENYLPROPANOL, PROPANEDIOL, TIN OXIDE, TITANIUM DIOXIDE (CI 77891), TOCOPHEROL.

🎯 Purpose 2 words ▾

PURPOSE SUNSCREEN

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
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 Skin Authority LLC. Listing status can change — the directory data on this page refreshes weekly.
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.
← 46007-0204-11 · Skin 46007-0849-03 · Skin →
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.