BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, and OCTISALATE 3 g/100g; 7.5 g/100g; 3.5 g/100g Lipstick — NDC 64141-0019-01 package photo

BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, and OCTISALATE 3 g/100g; 7.5 g/100g; 3.5 g/100g Lipstick

by Bobbi Brown Professional Cosmetics Inc. · 1 JAR in 1 CARTON (64141-019-01) / 15 g in 1 JAR
NDC 64141-0019-01
🏷️ FDA NDC (as labeled) 64141-019-01 billing pads the product 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 →

🆔 Identity & classification

FDA NDC (as labeled) 64141-019-01
Product NDC 64141-019
11-digit billing NDC 64141001901
UNII G63QQF2NOX, 4Y5P7MUD51, 4X49Y0596W
UPC 0716170027241
Application # M020
SPL Set ID 4bfbfac7-6738-4996-a152-95dfbd759154
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-02-01
Route TOPICAL
Dosage form LIPSTICK
Substance AVOBENZONE; OCTINOXATE; OCTISALATE
Why two NDCs? The FDA registers this code as 64141-019-01 — 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 → 64141-0019-01. 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

LabelerBobbi Brown Professional Cosmetics Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code64141
First marketedFeb 2002
Product typeHuman Otc Drug
Portfolio11 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 an over-the-counter lip balm sold as a lipstick formulation for topical application to the lips. It contains three sunscreen active ingredients (avobenzone, octinoxate, and octisalate) that are typically used to filter ultraviolet radiation and provide broad-spectrum sun protection. The product is marketed under the FDA's OTC monograph rules for sunscreen products rather than as an individually reviewed drug application. Lip balms with these ingredients are commonly used to help protect lip skin from sun exposure.

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 P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 3SW678MX72
    A natural flavoring derived from roasted arabica coffee beans. It adds coffee taste and aroma to the medicine, making it more palatable for patients who need to swallow or chew the product.
  • UNII 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII N863NB338G
    Benzyl benzoate is a liquid organic compound used as a solvent and preservative in medicines. It helps dissolve active ingredients and can extend shelf life by preventing microbial growth in liquid formulations.
  • 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 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 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • 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 L837108USY
    Geraniol is a natural fragrant compound found in plants like roses and lemons. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
  • UNII 73071MW2KM
    A waxy substance derived from glycerin and stearic acid that acts as a binder, emulsifier, and thickener in medicines. It helps hold solid formulations together and gives creams and lotions a smooth, stable texture.
  • UNII 9XP4LC555B
    A fragrance compound derived from natural plant sources or made synthetically. It's added to medicines as a flavoring agent to mask bitter tastes and improve how the medicine smells and tastes.
  • UNII XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • 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 3D47Q6D93C
    A synthetic ester derived from fatty acids, used as an emollient and lubricant in topical formulations. It helps soften the skin and improves the texture and spreadability of creams and ointments.
  • 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 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • 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 14C97E680P
    Wheat germ oil is an oil extracted from wheat kernels. It's used in medicines as an emollient and lubricant to improve texture and help ingredients blend smoothly.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statespetrolatum ■ microcrystalline wax\cera microcristallina\cire microcristalline ■ polybutene ■ bis-diglyceryl polyacyladipate-2 ■ octyldodecyl stearoyl stearate ■ beeswax\cera alba\cire d abeille ■ octyldodecanol ■ coffea arabica (coffee) seed extract ■ aloe barbadensis leaf extract ■ triticum vulgare (wheat) germ oil ■ persea gratissima (avocado) oil ■ olea europaea (olive) fruit oil ■ ozokerite ■ cholesterol ■ tocopheryl acetate ■ phytosphingosine ■ glycine soja (soybean) oil ■ glyceryl distearate ■ ricinus communis (castor) seed oil ■ caprylyl glycol ■ oleic acid ■ palmitic acid ■ fragrance (parfum) ■ alpha-isomethyl ionone ■ geraniol ■ citronellol ■ benzyl benzoate ■ titanium dioxide (ci 77891) ■ red 6 (ci 15850) <iln39883>

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 DailyMedingredient 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.
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
Bobbi Brown Lip Balm Broad Spectrum Spf 15 3 g/100g; 7.5 g/100g; 3.5 g/100gthis 64141-0019-01 Bobbi 1 jar 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

🏛️
2002
On the market since
Feb 2002
📍
2026
Currently FDA-listed
24 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 BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 (this brand).

Top reported reactions

Skin Cancer1

Reporter sex

1 reports
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 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
64141-0019-01 You're viewing this 1 JAR in 1 CARTON (64141-019-01) / 15 g in 1 JAR 2002-02-01 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 64141-019-01, 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: 64141-0019-01, written without dashes as 64141001901. 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 64141-0019-01, the first segment (64141) is the labeler code FDA assigned to Bobbi Brown Professional Cosmetics Inc.; the middle segment (0019) 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 Bobbi Brown Professional Cosmetics Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bobbi Brown Professional Cosmetics 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.

📄 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 4 words

Use Helps prevent sunburn

⏱️ Dosage and Administration 94 words

Directions For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

⚠️ Warnings 56 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 product is swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 14 words

Other information Protect the product in this container from excessive heat and direct sun.

🧪 Active Ingredient 8 words

Active Ingredients Avobenzone 3.00% Octinoxate 7.50% Octisalate 3.50%

🧪 Inactive Ingredients 108 words

Inactive ingredients petrolatum ■ microcrystalline wax\cera microcristallina\cire microcristalline ■ polybutene ■ bis-diglyceryl polyacyladipate-2 ■ octyldodecyl stearoyl stearate ■ beeswax\cera alba\cire d abeille ■ octyldodecanol ■ coffea arabica (coffee) seed extract ■ aloe barbadensis leaf extract ■ triticum vulgare (wheat) germ oil ■ persea gratissima (avocado) oil ■ olea europaea (olive) fruit oil ■ ozokerite ■ cholesterol ■ tocopheryl acetate ■ phytosphingosine ■ glycine soja (soybean) oil ■ glyceryl distearate ■ ricinus communis (castor) seed oil ■ caprylyl glycol ■ oleic acid ■ palmitic acid ■ fragrance (parfum) ■ alpha-isomethyl ionone ■ geraniol ■ citronellol ■ benzyl benzoate ■ titanium dioxide (ci 77891) ■ red 6 (ci 15850) <iln39883>

🎯 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 ↗
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.