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BROAD SPECTRUM SPF50 SPF 50 AVOBENZONE, Homosalate OCTISALATE, 3 g/100mL; 10 g/100mL; 5 g/100mL Gel, 30 mL — NDC 81104-0801-01 package photo

BROAD SPECTRUM SPF50 SPF 50 AVOBENZONE, Homosalate OCTISALATE, 3 g/100mL; 10 g/100mL; 5 g/100mL Gel, 30 mL

by NAKED SUNDAYS PTY LTD · 30 mL in 1 CONTAINER (81104-801-01)
NDC 81104-0801-01
🏷️ FDA NDC (as labeled) 81104-801-01 billing pads the product segment with a zero
This package
Contains30 mL Pack sizes3 compare ↓
Also comes in: 15 ml 81104-0801-03 50 ml 81104-0801-02
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) 81104-801-01
Product NDC 81104-801
11-digit billing NDC 81104080101
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID 0426b1e9-063b-c1e6-e063-6294a90a2554
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-30
Route TOPICAL
Dosage form GEL
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 81104-801-01 — 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 → 81104-0801-01. 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

LabelerNAKED SUNDAYS PTY LTD
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code81104
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio43 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a topical gel sunscreen marketed as an over-the-counter monograph product. It contains three UV-filtering ingredients: avobenzone, homosalate, and octisalate. These active ingredients are commonly used together in sunscreens to absorb and scatter ultraviolet radiation from the sun. The product is formulated to provide broad-spectrum sun protection and is applied to the skin.

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 GEV2EL4D9G
    A synthetic polymer made from acrylic compounds that form a network structure. It works as a thickener and gelling agent in topical products to create the right texture and consistency.
  • 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 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • 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 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 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 G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 0ZQ1D2FDLI
    A fruit extract from the kakadu plum tree, native to Australia. It's used in formulations as a source of vitamin C and as an antioxidant to help preserve the medicine's stability.
  • 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 R5P9Z5WD6D
    A synthetic polymer material made from acrylic acid compounds. It works as a binder to hold tablet ingredients together, a thickener in liquids, and helps control how quickly the medicine dissolves and releases in your body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 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.

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

The official label also statesInactive Ingredients: Water, Butyloctyl Salicylate, Propylene Glycol, Acrylates Copolymer, Euphorbia Cerifera (Candelilla) Wax, Phenoxyethanol, Hydroxyacetophenone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Tocopheryl Acetate, Polyacrylate Crosspolymer-6, Ethylhexylglycerin, Sodium Hyaluronate, Sodium Hydroxide, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Disodium EDTA, Citric Acid

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 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.
Try another pack size: 15 ml 50 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
Broad Spectrum Spf50 Spf 50 3 g/100mL; 10 g/100mL; 5 g/100mLthis 81104-0801-01 NAKED 30 ml — — FDA listed —
Hydrating Sunscreen Moisturizer Broad Spectrum Spf50 Spf 50 3 g/100mL; 10 g/100mL; 5 g/100mL 81104-0802-01 NAKED 50 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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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 AVOBENZONE, Homosalate OCTISALATE, — the ingredient across all brands.

Top reported reactions

Skin Cancer65
Rash53
Pruritus37
Erythema29
Dyspnoea27
Malignant Melanoma27
Neoplasm Malignant27

Reporter sex

0 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization109
Disabling26
Death23
Life-threatening12
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 232 7
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
81104-0801-01 You're viewing this 30 mL in 1 CONTAINER (81104-801-01) 2023-08-30 Active
81104-0801-02 50 mL in 1 CONTAINER (81104-801-02) 2024-04-01 Active
81104-0801-03 15 mL in 1 TUBE (81104-801-03) 2026-01-11 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 81104-0801-01?
NDC 81104-0801-01 contains 30 mL — 30 ml in 1 container.
What is the difference between NDC 81104-0801-01 and NDC 81104-0801-03?
Both are BROAD SPECTRUM SPF50 SPF 50 AVOBENZONE, Homosalate OCTISALATE, 3 g/100mL; 10 g/100mL; 5 g/100mL Gel — the drug itself is identical. NDC 81104-0801-01 is the 30 mL package, while NDC 81104-0801-03 is the 15 ml package.
What NDC number is used to bill for this package of BROAD SPECTRUM SPF50 SPF 50 AVOBENZONE, Homosalate OCTISALATE, 3 g/100mL; 10 g/100mL; 5 g/100mL Gel?
Bill NDC 81104-0801-01 — the 11-digit billing format is 81104080101. 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 81104-801-01, 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: 81104-0801-01, written without dashes as 81104080101. 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 81104-0801-01, the first segment (81104) is the labeler code FDA assigned to NAKED SUNDAYS PTY LTD; 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 NAKED SUNDAYS PTY LTD. 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 2 other package presentations of this same product, including 15 ml (81104-0801-03), 50 ml (81104-0801-02). 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?
NAKED SUNDAYS PTY LTD is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings and Cautions ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 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 ageing caused by the sun.

⏱️ Dosage and Administration 105 words ▾

DIRECTIONS SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying.

Reapply at least every 2 hours. Children under 3 years of age: Ask a doctor. 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 10.00AM - 2.00PM Wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings and Cautions 95 words ▾

Directions: Apply generously 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying.

Reapply at least every 2 hours. Children under 6 months of age: Ask a doctor. 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 10AM - 2PM Wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings ~1 min read ▾

WARNINGS Warnings: For external use only. 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.

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. Use a water-resistant sunscreen if swimming or sweating.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.

Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. Reapply at least every 2 hours.

Children under 3 years of age: Ask a doctor. 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 10.00AM - 2.00PM Wear long-sleeved shirts, pants, hats, and sunglasses

🧪 Active Ingredient 10 words ▾

ACTIVE INGREDIENTS Avobenzone 3% Homosalate 10% Octilsalate 5% Purpose Sunscreen

🧪 Inactive Ingredients 41 words ▾

INACTIVE INGREDIENTS Inactive Ingredients: Water, Butyloctyl Salicylate, Propylene Glycol, Acrylates Copolymer, Euphorbia Cerifera (Candelilla) Wax, Phenoxyethanol, Hydroxyacetophenone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Tocopheryl Acetate, Polyacrylate Crosspolymer-6, Ethylhexylglycerin, Sodium Hyaluronate, Sodium Hydroxide, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Disodium EDTA, Citric Acid

🎯 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 ↗
← 81104-0800-01 · NAKED 81104-0802-01 · NAKED →
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.