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Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream 11.99 g/100g Stick, 1 tube — NDC 51514-0369-02 package photo

Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream 11.99 g/100g Stick, 1 tube

by Autumn Harp · 1 TUBE in 1 CARTON (51514-0369-2) / 4.25 g in 1 TUBE (51514-0369-1)
NDC 51514-0369-02
🏷️ FDA NDC (as labeled) 51514-0369-2 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

🆔 Identity & classification

FDA NDC (as labeled) 51514-0369-2
Product NDC 51514-0369
11-digit billing NDC 51514036902
UNII SOI2LOH54Z
UPC 0792850659353, 0792850659339, 0792850659322
Application # M020
SPL Set ID 1ac89261-eeae-567c-e063-6294a90ad45f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-06-01
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 51514-0369-2 — 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 → 51514-0369-02. 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.

🏭 Manufacturer & labeler

LabelerAutumn Harp
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code51514
First marketedJun 2024
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?

Burts Bees SPF 30 Untinted Lip Balm is a topical stick containing zinc oxide, a mineral sunscreen ingredient. This over-the-counter monograph product is typically used to help protect lip skin from sun damage. Zinc oxide functions as a broad-spectrum UV filter that reflects and scatters ultraviolet rays. The product is formulated as a moisturizing balm applied directly to the lips.

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 36HQN158VC
    Alpha-bisabolol is a naturally derived oily liquid from plant sources. It works as a fragrance, flavor, and skin-conditioning agent in topical medicines and cosmetic products.
  • UNII WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII 7QWA1RIO01
    A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • 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 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 5EM498GW35
    A mixture of aromatic compounds used to add pleasant smell to the medicine. Fragrance helps mask unpleasant tastes or odors, making the medication easier to take.
  • UNII B68LJT9544
    A fatty acid derivative used as a preservative and antimicrobial agent in topical medicines. It helps prevent bacterial and fungal growth to maintain product stability and safety.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • 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 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 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 MZQ63P0N0W
    A plant-derived emulsifier made from glycerin and castor oil. It helps mix oil and water ingredients together in formulations like creams and lotions, keeping them blended.
  • 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 C2BRV53B1V
    A plant-derived oil from pongamia seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product texture while improving how it spreads on skin.
  • 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 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 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

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

The official label also statesBeaches and Cream - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Natural Fragrance, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Glyceryl Undecylenate. Tropic Like It's Hot - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Natural Fragrance, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Orange Oil Terpenes, Limonene, Linalool, Glyceryl Undecylenate, Amyl Cinnamal. Coco Loco - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Citrus Aurantium Dulcis (Orange) Peel Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Ricinus Communis (Castor) Seed Oil, Curcuma Longa (Turmeric) Root Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Natural Fragrance, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Limonene, Glyceryl Undecylenate, Amyl Cinnamal, Benzyl Salicylate, Hydroxycitronellal, Eugenol, Linalool.

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.
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
Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream 11.99 g/100gthis 51514-0369-02 Autumn 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
Jun 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51514-0369-02 You're viewing this 1 TUBE in 1 CARTON (51514-0369-2) / 4.25 g in 1 TUBE (51514-0369-1) 2024-06-01 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 51514-0369-2, 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: 51514-0369-02, written without dashes as 51514036902. 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 51514-0369-02, the first segment (51514) is the labeler code FDA assigned to Autumn Harp; the middle segment (0369) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Autumn Harp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Autumn Harp 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 28 words ▾

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.

⏱️ Dosage and Administration 94 words ▾

For sunscreen use: - Apply liberally 15 minutes before sun exposure. - Use a water-resistant sunscreen if swimming or sweating. - Reapply 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 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: Ask a doctor.

⚠️ Warnings 55 words ▾

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.

🧪 Active Ingredient 5 words ▾

Zinc Oxide 12% - Sunscreen

🧪 Inactive Ingredients ~1 min read ▾

Beaches and Cream - Inactive Ingredients : Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Natural Fragrance, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Glyceryl Undecylenate.

Tropic Like It's Hot - Inactive Ingredients: Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Natural Fragrance, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Orange Oil Terpenes, Limonene, Linalool, Glyceryl Undecylenate, Amyl Cinnamal.

Coco Loco - Inactive Ingredients : Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Argania Spinosa Kernel Oil, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Glyceryl Caprylate, Tocopherol, Citrus Aurantium Dulcis (Orange) Peel Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Ricinus Communis (Castor) Seed Oil, Curcuma Longa (Turmeric) Root Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Natural Fragrance, Pongamia pinnata seed extract, Bisabolol, Glycine Soja (Soybean) Oil, Limonene, Glyceryl Undecylenate, Amyl Cinnamal, Benzyl Salicylate, Hydroxycitronellal, Eugenol, Linalool.

🎯 Purpose 28 words ▾

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51514-0368-02 · Autumn 51514-0370-02 · Autumn →
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.