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FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 ZINC OXIDE 150 mg/mL Liquid — NDC 69435-1409-01 package photo

FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 ZINC OXIDE 150 mg/mL Liquid

by Peer Pharm Ltd. · 1 TUBE in 1 CARTON (69435-1409-1) / 15 mL in 1 TUBE
NDC 69435-1409-01
🏷️ FDA NDC (as labeled) 69435-1409-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 69435-1409-1
Product NDC 69435-1409
11-digit billing NDC 69435140901
UNII SOI2LOH54Z
Application # M020
SPL Set ID 2baf0278-7e13-4db0-e063-6294a90ae9de
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-14
Route TOPICAL
Dosage form LIQUID
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 69435-1409-1 — 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 → 69435-1409-01. 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

LabelerPeer Pharm Ltd.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69435
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio17 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?

This is a topical lip tint liquid that contains zinc oxide, an inorganic mineral commonly used in over-the-counter sunscreen products to reflect and scatter ultraviolet light. The product is marketed under FDA's over-the-counter monograph rules for sunscreen ingredients rather than as an individually approved application. Zinc oxide in lip products typically functions as a sun-protective agent 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.

🧪 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 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 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII 51XV5WTF7E
    A plant extract from the argan tree's leaves. Used in topical products as a conditioning agent and emollient to help soften and smooth skin or hair.
  • 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 43AGM4PHPI
    A mixture of plant or animal oils and fats with 10 to 18 carbon chains. Used as a solvent and carrier to dissolve or suspend active ingredients, helping deliver the medicine effectively.
  • 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 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 D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII 9M64UO4C25
    A synthetic oily substance used as an emollient and texture enhancer in medicines. It helps soften formulations, improves how the medicine spreads or feels on skin, and can act as a lubricant in tablets or capsules.
  • UNII 481744AI4O
    A synthetic red dye used to color medicines and products. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • 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 AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII I9GRO824LL
    Lemon oil is a natural fragrant extract from lemon peel. It's used in medicines as a flavoring agent to mask unpleasant tastes and improve how the medicine tastes to patients.
  • 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 K168T6Y0YU
    A plant-based oil derived from rapeseed that has been chemically treated to make it solid at room temperature. It acts as a binder, lubricant, and coating agent to help hold tablet ingredients together and improve how the medicine flows during manufacturing.
  • 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 S870P55O2W
    Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
  • UNII 949E3KBJ1I
    Isopropyl titanium triisostearate is a titanium-based compound used in medicines as a glidant and anticaking agent. It helps powders and granules flow smoothly during manufacturing and prevents clumping in the finished product.
  • UNII 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • UNII T7A529FB8O
    A synthetic compound derived from amino acids and palmitic acid, used as a skin-conditioning agent or emollient in topical formulations to help soften and protect the skin surface.
  • UNII 1NA5AO9GH7
    A synthetic polymer derived from petroleum, polybutene is used as a binder and lubricant in solid medications to help hold ingredients together and improve the tablet or capsule's flow during manufacturing.
  • 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 II29C6E5R3
    A plant-derived ingredient from the pigweed species. It acts as a natural binder and thickener to help hold the medication's components together and improve texture and consistency.
  • 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 01S2G2C1E4
    Sorbitan isostearate is an emulsifier derived from sorbitol and isostearic acid. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
  • UNII 3H18P0UK73
    Sucrose cocoate is a natural emulsifier made from coconut oil and sugar. It helps blend water and oil-based ingredients together in formulations.
  • UNII 248P1AUJ90
    A manufactured waxy substance used to coat and protect tablet or capsule contents. It slows how quickly the medicine dissolves, helping control the release of the active ingredient into your body.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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.

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

The official label also statesRicinus Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Polybutene, Butyrospermum Parkii (Shea) Butter, Butyloctyl Salicylate,Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Rapeseed Oil, Isodecyl Neopentanoate, Argania Spinosa Kernel Oil, C10-18 Triglyceride, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Water, Citrus Aurantium Dulcis Peel Oil, Citrus Limon (Lemon) Peel Oil, Glycerin, Argania Spinosa Leaf Extract, Argania Spinosa Callus Culture Extract, Isomalt, Lecithin, Cetearyl Ethylhexanoate, Sorbitan Isostearate, Portulaca Pilosa Extract, Sucrose Cocoate, Palmitoyl Tripeptide-38, Alcohol, Synthetic Wax, Isopropyl Titanium Triisostearate, Red 27 Lake (CI 45410), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Red 6 Lake (CI 15850).

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40 150 mg/mL 87018-0875-00 ALL 1 bottle — — FDA listed —
Fre Plump Me Peptide Lip Tint Pampelonne Spf 30 150 mg/mL 69435-1410-01 Peer 1 tube — — FDA listed —
Eminence Radiant Protection SPF Fluid 150 mg/mL 15751-3506-01 Eminence 1 bottle — — FDA listed —
Fre Plump Me Peptide Lip Tint Cassis Spf 30 150 mg/mL 69435-1411-01 Peer 1 tube — — FDA listed —
Hawaii Sol Natural Non-Nano Sunscreen SPF 50 150 mg/mL 82520-0957-00 Caribbean 177 ml — — FDA listed —
Caribbean Sol Natural Non-Nano Sunscreen SPF 50 150 mg/mL 82520-0956-00 Caribbean 177 ml — — FDA listed —
MIAMI BEACH BUM SPF-50 Blocked Sunscreen 150 mg/mL 82812-0448-00 MIAMI 177 ml — — FDA listed —
Fre Plump Me Peptide Lip Tint Monaco Spf 30 150 mg/mLthis 69435-1409-01 Peer 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

🏛️
2025
On the market since
Jan 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 FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Reporter sex

0 reports

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 229 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69435-1409-01 You're viewing this 1 TUBE in 1 CARTON (69435-1409-1) / 15 mL in 1 TUBE 2025-01-14 Active

🧭 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 69435-1409-1, 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: 69435-1409-01, written without dashes as 69435140901. 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 69435-1409-01, the first segment (69435) is the labeler code FDA assigned to Peer Pharm Ltd.; the middle segment (1409) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Peer Pharm Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Peer Pharm Ltd. 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 102 words ▾

Directions • Apply liberally 15 minutes before sun exposure. • 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. • Limit time in the sun, especially from 10 a.m.- 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses. • For children under 6 months of age: Ask a doctor.

⏱️ Dosage and Administration 31 words ▾

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

⚠️ 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 swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredients Zinc Oxide 15%

🧪 Inactive Ingredients 95 words ▾

Inactive Ingredients Ricinus Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Polybutene, Butyrospermum Parkii (Shea) Butter, Butyloctyl Salicylate,Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Rapeseed Oil, Isodecyl Neopentanoate, Argania Spinosa Kernel Oil, C10-18 Triglyceride, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Water, Citrus Aurantium Dulcis Peel Oil, Citrus Limon (Lemon) Peel Oil, Glycerin, Argania Spinosa Leaf Extract, Argania Spinosa Callus Culture Extract, Isomalt, Lecithin, Cetearyl Ethylhexanoate, Sorbitan Isostearate, Portulaca Pilosa Extract, Sucrose Cocoate, Palmitoyl Tripeptide-38, Alcohol, Synthetic Wax, Isopropyl Titanium Triisostearate, Red 27 Lake (CI 45410), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Red 6 Lake (CI 15850).

🎯 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 ↗
← 69435-1408-01 · Peer 69435-1410-01 · Peer →
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.