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pavise Lip Defense tinted hydrating oil (hue 604) Zinc Oxide 100 mg/mL Lotion — NDC 83100-1761-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

pavise Lip Defense tinted hydrating oil (hue 604) Zinc Oxide 100 mg/mL Lotion — NDC 83100-1761-2 (Billing 83100-1761-02)

by B.A.I. Biosciences INC. · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of pavise Lip Defense tinted hydrating oil (hue 604) Zinc Oxide 100 mg/mL Lotion from B.A.I. Biosciences INC., marketed since Feb 2023 and currently FDA-listed. It is this product's only package size.

NDC 83100-1761-02
🏷️ FDA NDC (as labeled) 83100-1761-2 billing pads the package segment with a zero
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

NDC database record

One package, one record: these facts belong to NDC 83100-1761-2 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83100 labeler · 1761 product · 2 package
Package marketed since
Feb 17, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8310017612 8
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83100-1761-2
Product NDC 83100-1761
11-digit billing NDC 83100176102
UNII SOI2LOH54Z
Application # M020
SPL Set ID f4ebbc1d-d521-1a47-e053-2a95a90a6f84
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-17
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83100-1761-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 83100-1761-02. 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?

Pavise Lip Defense tinted hydrating oil is an over-the-counter topical lotion applied to the lips. It contains zinc oxide, a mineral ingredient commonly used in lip care and sun protection products to help shield the skin from ultraviolet rays. The product is formulated as a tinted hydrating oil, combining sun-protective and moisturizing functions for lip care.

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
83100-1761-02 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2023-02-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dr. Perrys Day Thyme SPF 20 Broad Spectrum Sunscreen 100 mg/mL 14268-0017-00 Englewood 1 bottle — — FDA listed —
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush Much 100 mg/mL 76354-0127-01 e.l.f. 1 tube — — FDA listed —
elf Sun Boss Gloss SPF 25 Sunscreen Peachy Kween 100 mg/mL 76354-0134-01 e.l.f. 1 tube — — FDA listed —
pavise Lip Defense tinted hydrating oil (hue 604) 100 mg/mLthis 83100-1761-02 B.A.I. 1 bottle — — FDA listed —
pavise Lip Defense tinted hydrating oil (hue 774) 100 mg/mL 83100-1763-02 B.A.I. 1 bottle — — FDA listed —
Avene Cleanance Mattifying SPF 30 100 mg/mL 64760-0786-01 Pierre 1 tube — — Discontinued —
Ghosted 100 mg/mL 85385-0246-01 Spooge 1 tube — — FDA listed —
Bright as Day Mineral SPF50 100 mg/mL 84130-0005-03 Koco 8 ml — — FDA listed —
Avene Hydrance Moisturizing SPF 30 100 mg/mL 64760-0783-01 Pierre 1 tube — — FDA listed —
Tatcha The Silk Sunscreen 100 mg/mL 69417-0130-05 TATCHA 1 bottle — — FDA listed —
e l f Sun Boss Gloss SPF 25 Sunscreen Its your Mauve 100 mg/mL 76354-0129-01 e.l.f. 1 tube — — FDA listed —
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my Jam 100 mg/mL 76354-0128-01 e.l.f. 1 tube — — FDA listed —
Naturium Dew Glow Moisturizer Mineral SPF 50 100 mg/mL 76354-0300-01 e.l.f. 1 tube — — FDA listed —
Colorescience Total Protection No Show Mineral Body Shield 100 mg/mL 68078-0892-02 Colorescience 1 tube — — FDA listed —
Colorescience Total Protection Body Shield Glow 100 mg/mL 68078-0893-02 Colorescience 1 tube — — FDA listed —
Mental Skin Care Lip Shield Intent 100 mg/mL 82696-4440-02 Mental 1 bottle — — FDA listed —
pavise Lip Defense tinted hydrating oil (hue 616) 100 mg/mL 83100-1762-02 B.A.I. 1 bottle — — FDA listed —
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me Girl 100 mg/mL 76354-0126-01 e.l.f. 1 tube — — 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
Feb 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 105S6I733Z
    A natural oil extracted from chamomile and other plants. It acts as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • 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 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 6GRV67N0U2
    Diamond powder is a finely ground form of crystalline carbon. It's used in some formulations as a polishing or abrasive agent, and occasionally as a colorant or for texture in solid dosage forms.
  • UNII QBS8A3XZGQ
    A synthetic oil made from diisostearyl alcohol and malic acid. It serves as an emollient and solvent in formulations, helping to dissolve and deliver active ingredients while improving texture and spreadability.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • 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 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 7B8OE71MQC
    A synthetic emulsifier derived from glycerin and fatty acids. It helps oils and water mix together in formulations, keeping ingredients evenly distributed throughout the product.
  • UNII 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 FY36J270ES
    A synthetic chemical compound used as a plasticizer in film coatings. It makes tablet or capsule coatings flexible and durable so they don't crack or break during handling and storage.
  • UNII 06YD7896S3
    A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.

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

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

LabelerB.A.I. Biosciences INC.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83100
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from B.A.I. Biosciences INC. labeler code 83100

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

pavise Lip Defense tinted hydrating oil (hue 604) Indications & usage

⏱️ Dosage and Administration 11 words ▾

pavise Lip Defense tinted hydrating oil (hue 604) Dosage and Administration

⚠️ Warnings 10 words ▾

pavise Lip Defense tinted hydrating oil (hue 604) Warning Label

🧪 Active Ingredient 10 words ▾

pavise Lip Defense tinted hydrating oil (hue 604) Active Ingredients

🧪 Inactive Ingredients 10 words ▾

pavise Lip Defense tinted hydrating oil (hue 604) Inactive ingredients

🎯 Purpose 9 words ▾

pavise Lip Defense tinted hydrating oil (hue 604) purpose

📄 Keep Out of Reach of Children 14 words ▾

pavise Lip Defense tinted hydrating oil (hue 604) keep out of reach of children

📄 Package Label / Principal Display Panel 9 words ▾

pavise Lip Defense tinted hydrating oil (hue 604) PDP

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 B.A.I. Biosciences INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
B.A.I. Biosciences INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 83100-1720-03 · B.A.I 83100-1762-02 · B.A.I. →
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.