Sun Bum 15 Premium Sunscreen Browning AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 50 mg/mL; 20 mg/mL; 20 mg/mL; 100 mg/mL Lotion, 250 mL — NDC 69039-0801-01 package photo

Sun Bum 15 Premium Sunscreen Browning AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 50 mg/mL; 20 mg/mL; 20 mg/mL; 100 mg/mL Lotion, 250 mL

by Sun Bum, LLC · 250 mL in 1 BOTTLE, PLASTIC (69039-801-01)
NDC 69039-0801-01
🏷️ FDA NDC (as labeled) 69039-801-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 69039-801-01
Product NDC 69039-801
11-digit billing NDC 69039080101
UNII V06SV4M95S, G63QQF2NOX, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID 3c5b0db8-f05a-2b5c-e063-6294a90ae79b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-01
Route TOPICAL
Dosage form LOTION
Substance HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 69039-801-01 — 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 → 69039-0801-01. 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

LabelerSun Bum, LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code69039
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio116 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?

Sun Bum 15 Premium Sunscreen Browning is a topical lotion that combines four UV-filtering ingredients. Avobenzone, homosalate, octisalate, and octocrylene are all chemical sunscreen agents commonly used to absorb and scatter ultraviolet radiation from the sun. This product is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen products rather than through individual application review. The lotion form allows for easy application to the skin.

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 8Z5ZAL5H3V
    A synthetic polymer made from acrylate compounds. It acts as a thickener and stabilizer in topical formulations, helping create the right texture and prevent separation of ingredients.
  • UNII RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • 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 T9D99G2B1R
    Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
  • UNII KU94FIY6JB
    A natural enzyme extract from papaya fruit that helps break down proteins. It's used in some medicines as a digestive aid ingredient and may help tablets dissolve or break apart in the stomach.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII IK55HKE887
    A natural oil extracted from arabica coffee beans. It adds flavor and aroma to the medicine and may help improve taste or serve as a lubricant in the formulation.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • UNII 86FQE96TZ4
    A synthetic polymer, this ingredient acts as a thickener and suspending agent in liquid formulations. It helps maintain uniform consistency and keeps particles evenly distributed throughout the medicine.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII TP11QR7B8R
    A natural oil extracted from kukui nuts, used as an emollient and skin-conditioning agent in topical medicines. It helps soften the formulation and improve how the product spreads and absorbs into skin.
  • UNII 9E3P882579
    A seaweed-derived thickening and gelling agent made from brown kelp. It helps stabilize the medicine's texture and may be used as a binder or suspending agent to keep ingredients evenly mixed.
  • UNII 515610SU8C
    Macadamia oil is a plant-derived oil extracted from macadamia nuts. In medicines, it serves as an emollient and solvent to help dissolve or suspend active ingredients and improve product texture and absorption.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII W00LYS4T26
    Manganese sulfate is a mineral salt containing manganese. It may be used as a nutritional supplement or trace mineral fortification in some formulations.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII X3W0AM1JLX
    A synthetic red dye used to color medicines and products. It helps make pills, liquids, and capsules visually distinct and easier to identify.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective 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 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.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.

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

The official label also stateswater, caprylic/capric triglyceride, cocos nucifera (coconut) oil, glyceryl stearate, PEG-100 stearate, fragrance, caramel, cetyl alcohol, aloe barbadensis leaf juice, argania spinosa (argan) kernel oil, aleurites moluccana (kukui) seed oil, coffea arabica (coffee) seed oil, carica papaya fruit extract, zingiber officinale (ginger) root extract, helianthus annuus (sunflower) extract, macadamia ternifolia seed oil, glycerin, hydrolyzed algin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylates/c10-30 alkyl acrylate crosspolymer, tocopheryl acetate, tocopherol, magnesium sulfate, manganese sulfate, isohexadecane, polysorbate 60, caffeine, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, blue no. 1, red no. 33, red no. 4, yellow no. 6

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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sun Bum 15 Premium Sunscreen Browning 50 mg/mL; 20 mg/mL; 20 mg/mL; 100 mg/mLthis 69039-0801-01 Sun 250 ml 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 Sun Bum 15 Premium Sunscreen Browning (this brand).

Top reported reactions

Acute Myeloid Leukaemia2
Exposure To Toxic Agent2
Product Contamination Chemical2
Rash2
Anaphylactic Reaction1
Application Site Erythema1
Application Site Exfoliation1

Age at onset

Adolescent2
Adult1

Reporter sex

6 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization2
Death1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 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
69039-0801-01 You're viewing this 250 mL in 1 BOTTLE, PLASTIC (69039-801-01) 2025-01-01 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 69039-801-01, 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: 69039-0801-01, written without dashes as 69039080101. 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 69039-0801-01, the first segment (69039) is the labeler code FDA assigned to Sun Bum, LLC; the middle segment (0801) 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 Sun Bum, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sun Bum, LLC 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 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

⏱️ Dosage and Administration 14 words

Directions • shake well before use • apply liberally 15 minutes before sun exposure

⚠️ Warnings 53 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 immediately.

🧪 Active Ingredient 10 words

Active Ingredients Homosalate: 5% Octocrylene: 10% Octisalate: 2% Avobenzone 2%

🧪 Inactive Ingredients 92 words

Inactive Ingredients water, caprylic/capric triglyceride, cocos nucifera (coconut) oil, glyceryl stearate, PEG-100 stearate, fragrance, caramel, cetyl alcohol, aloe barbadensis leaf juice, argania spinosa (argan) kernel oil, aleurites moluccana (kukui) seed oil, coffea arabica (coffee) seed oil, carica papaya fruit extract, zingiber officinale (ginger) root extract, helianthus annuus (sunflower) extract, macadamia ternifolia seed oil, glycerin, hydrolyzed algin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylates/c10-30 alkyl acrylate crosspolymer, tocopheryl acetate, tocopherol, magnesium sulfate, manganese sulfate, isohexadecane, polysorbate 60, caffeine, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, blue no.

1, red no. 33, red no. 4, yellow no.

6

🎯 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.