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Rodan and Fields Plumping Lip SPF 28 Sunscreen Octinoxate, Zinc Oxide 7.4 g/100mL; 7 g/100mL Oil — NDC 14222-3000-03 package photo

Rodan and Fields Plumping Lip SPF 28 Sunscreen Octinoxate, Zinc Oxide 7.4 g/100mL; 7 g/100mL Oil

by Rodan & Fields · 1 TUBE in 1 BOX (14222-3000-3) / 5 mL in 1 TUBE
NDC 14222-3000-03
🏷️ FDA NDC (as labeled) 14222-3000-3 billing pads the package segment with a zero
This package
Contains5 mL in 1 tube Pack sizes4 compare ↓
Also comes in: 5 mL 14222-3000-01 5 mL 14222-3000-02 5 mL 14222-3000-04
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

🆔 Identity & classification

FDA NDC (as labeled) 14222-3000-3
Product NDC 14222-3000
11-digit billing NDC 14222300003
UNII 4Y5P7MUD51, SOI2LOH54Z
Application # M020
SPL Set ID edf05ccc-4299-48d5-8f8e-01255eca11c2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-16
Route TOPICAL
Dosage form OIL
Substance OCTINOXATE; ZINC OXIDE
Why two NDCs? The FDA registers this code as 14222-3000-3 — 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 → 14222-3000-03. 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

LabelerRodan & Fields
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code14222
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio29 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?

Rodan and Fields Plumping Lip SPF 28 Sunscreen is a topical oil product intended for application to the lips. It contains two active ingredients, octinoxate and zinc oxide, which are ultraviolet light filters commonly used in sunscreen products to help protect the skin from sun exposure. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rule-book for sunscreen products rather than as an individually reviewed application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • 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 4MM76N4WMY
    A synthetic glass-like mineral compound containing calcium, sodium, and boron. Used as a colorant, opacifying agent, and filler in medicines to provide white color, improve appearance, and add bulk to tablets or capsules.
  • UNII 00UK7646FG
    Capsicum is a natural plant extract from red peppers. It's used as a colorant and flavoring agent to give medicines their red or orange appearance and mild spicy taste.
  • 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 89B2BSF9I3
    A synthetic compound made by chemically combining corn dextrin (a starch derivative) with palmitic acid. It acts as a binder and flow agent, helping hold tablet ingredients together and improve powder handling during manufacturing.
  • UNII E6AHA53N1H
    A synthetic amino acid derivative used as a skin-conditioning agent and emollient in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • 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 J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 Z3MP1W91CW
    A fatty substance derived from glycerin and oleic acid. It acts as an emulsifier to help blend oil and water-based ingredients, and may serve as a lubricant or thickening agent in the formulation.
  • UNII A626UU0W2A
    Glyceryl monobehenate is a waxy substance made from glycerin and behenic acid. It's used as a binder and lubricant to help hold tablet ingredients together and improve how smoothly the medicine flows during manufacturing.
  • UNII O05EC62663
    A natural oil derived from glycerin and oleic acid. It acts as a lubricant and emollient in medicines, helping ingredients mix smoothly and improving how the product flows during manufacturing and application.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 7D1YQ9Y5EZ
    Hydrogenated polybutene is a thick, wax-like ingredient made by chemically processing petroleum. It acts as a binder and lubricant, helping hold tablet ingredients together and allowing pills to slide smoothly during manufacturing and packaging.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 9KJL21T0QJ
    Linoleic acid is an omega-6 fatty acid derived from plant oils. It serves as an emulsifier and skin conditioning agent in topical formulations, helping ingredients mix smoothly and improving product texture.
  • UNII 0RBV727H71
    A natural fatty acid derived from plant oils. It helps dissolve other ingredients and improve how the medicine spreads or absorbs in the body.
  • UNII YK3DC63Y5M
    A mineral compound derived from natural or synthetic sources that acts as an anti-caking agent and flow aid. It helps prevent clumping and improves the powder's ability to flow smoothly during manufacturing and tablet formation.
  • 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII 2UMI9U37CP
    Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
  • UNII 2V16EO95H1
    Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
  • UNII RV743D216M
    A synthetic peptide derived from fatty acids and amino acids. It functions as a skin-conditioning agent and emollient in topical formulations, helping soften and smooth the product texture while supporting skin hydration.
  • UNII DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • 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 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 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during 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 8OC9U7TQZ0
    Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.

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

The official label also statesHydrogenated Polyisobutene, Phenyl Trimethicone, Ethylhexyl Palmitate, Dextrin Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glyceryl Behenate, Disteardimonium Hectorite, Dipalmitoyl Hydroxyproline, BHT, C10-18 Triglycerides, Calcium Sodium Borosilicate, Capsicum Annuum Extract (Fruit), Glyceryl Dioleate, Menthol, Lactic Acid, Linoleic Acid, Linolenic Acid, Octyldodecanol, Oleic Acid, Palmitic Acid, Palmitoyl Tripeptide-1, Polyhydroxystearic Acid, Sodium Hyaluronate, Sorbitan Isostearate, Sorbitan Oleate, Stearic Acid, Synthetic Fluorphlogopite, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Tribehenin, Triolein,+/-: Blue 1 Lake (Cl 42090), Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Red 6 (Cl 15850), Yellow 5 Lake (Cl 19140).

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 eachPer 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: 5 mL 5 mL 5 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rodan and Fields Plumping Lip SPF 28 Sunscreen 7.4 g/100mL; 7 g/100mLthis 14222-3000-03 Rodan 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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.

🔬 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 Octinoxate, Zinc Oxide — the ingredient across all brands.

Top reported reactions

Application Site Erythema2
Application Site Swelling2
Pruritus2
Skin Exfoliation2
Urticaria2
Anaphylactic Shock1
Application Site Burn1

Age at onset

Adult1

Reporter sex

8 reports
Female · 100%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 3 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
14222-3000-01 1 TUBE in 1 BOX (14222-3000-1) / 5 mL in 1 TUBE 2024-05-16 Active
14222-3000-02 1 TUBE in 1 BOX (14222-3000-2) / 5 mL in 1 TUBE 2024-05-16 Active
14222-3000-03 You're viewing this 1 TUBE in 1 BOX (14222-3000-3) / 5 mL in 1 TUBE 2024-05-16 Active
14222-3000-04 1 TUBE in 1 BOX (14222-3000-4) / 5 mL in 1 TUBE 2024-05-16 Active

Pack size FAQ

What quantity is in NDC 14222-3000-03?
NDC 14222-3000-03 is listed by the FDA — 1 tube in 1 box / 5 ml in 1 tube.
What NDC number is used to bill for this package of Rodan and Fields Plumping Lip SPF 28 Sunscreen Octinoxate, Zinc Oxide 7.4 g/100mL; 7 g/100mL Oil?
Bill NDC 14222-3000-03 — the 11-digit billing format is 14222300003. 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 14222-3000-3, 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: 14222-3000-03, written without dashes as 14222300003. 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 14222-3000-03, the first segment (14222) is the labeler code FDA assigned to Rodan & Fields; the middle segment (3000) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Rodan & Fields. 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 3 other package presentations of this same product, including 1 tube (14222-3000-01), 1 tube (14222-3000-02), 1 tube (14222-3000-04). 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?
Rodan & Fields 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 4 words ▾

Uses helps prevent sunburn.

⏱️ Dosage and Administration 44 words ▾

Directions apply generously, covering lips completely at least 15 minutes before sun exposure. Do not apply outside of lip lines. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor.

⚠️ Warnings 91 words ▾

Warnings Skin Cancer/ Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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 7 words ▾

Active Ingredients Octinoxate 7.4% Zinc Oxide 7%

🧪 Inactive Ingredients 90 words ▾

Inactive ingredients: Hydrogenated Polyisobutene, Phenyl Trimethicone, Ethylhexyl Palmitate, Dextrin Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glyceryl Behenate, Disteardimonium Hectorite, Dipalmitoyl Hydroxyproline, BHT, C10-18 Triglycerides, Calcium Sodium Borosilicate, Capsicum Annuum Extract (Fruit), Glyceryl Dioleate, Menthol, Lactic Acid, Linoleic Acid, Linolenic Acid, Octyldodecanol, Oleic Acid, Palmitic Acid, Palmitoyl Tripeptide-1, Polyhydroxystearic Acid, Sodium Hyaluronate, Sorbitan Isostearate, Sorbitan Oleate, Stearic Acid, Synthetic Fluorphlogopite, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Tribehenin, Triolein,+/-: Blue 1 Lake (Cl 42090), Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Red 6 (Cl 15850), Yellow 5 Lake (Cl 19140).

🎯 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 ↗
← 14222-2440-01 · Rodan 14222-3001-01 · Rodan →
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.