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Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum Avobenzone, Homosalate, Octisalate, Octocrylene 3 g/100mL; 5 g/100mL; 5 g/100mL; 10 g/100mL Spray, 75 mL

by NAKED SUNDAYS PTY LTD · 75 mL in 1 BOTTLE, SPRAY (81104-017-03)
NDC 81104-0017-03
🏷️ FDA NDC (as labeled) 81104-017-03 billing pads the product segment with a zero
This package
Contains75 mL Pack sizes2 compare ↓
Also comes in: 30 ml 81104-0017-01
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 →

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) 81104-017-03
Product NDC 81104-017
11-digit billing NDC 81104001703
UNII G63QQF2NOX, 5A68WGF6WM, 4X49Y0596W, V06SV4M95S
Application # M020
SPL Set ID 496ba4c4-6577-88ff-e063-6294a90a0995
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-16
Route TOPICAL
Dosage form SPRAY
Substance AVOBENZONE; OCTOCRYLENE; OCTISALATE; HOMOSALATE
Why two NDCs? The FDA registers this code as 81104-017-03 — 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 → 81104-0017-03. 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

LabelerNAKED SUNDAYS PTY LTD
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code81104
First marketedJan 2026
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 an over-the-counter sunscreen spray marketed under FDA's OTC monograph rules. It contains four UV-filtering ingredients (avobenzone, homosalate, octisalate, and octocrylene) that are commonly used together to block ultraviolet radiation from the sun. The spray form is applied topically to the skin and is labeled as providing broad-spectrum protection with SPF 50. This type of product is typically used to help protect exposed skin from sunburn and sun damage.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 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 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 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII W8K377W98I
    A mixture of sugars made by rearranging glucose molecules. It acts as a sweetener and filler to improve taste and add bulk to the medicine while helping it hold together.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 L33J06UQTT
    A plant-derived oil from watermelon seeds used as an emollient and skin-conditioning agent in topical formulations. It helps soften the product texture and improve how it spreads on skin.

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

The official label also statesCitric Acid, Citrullus Lanatus (Watermelon) Seed Oil, Fragrance, Glycerin, Potassium Sorbate, SD Alcohol 40-B, Saccharide Isomerate, Sodium Benzoate, Sodium Citrate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

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 mLPer 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: 30 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
Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum 3 g/100mL; 5 g/100mL; 5 g/100mL; 10 g/100mLthis 81104-0017-03 NAKED 75 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum (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
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2025 2026 2 1
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
81104-0017-01 30 mL in 1 BOTTLE, SPRAY (81104-017-01) 2026-01-16 Active
81104-0017-03 You're viewing this 75 mL in 1 BOTTLE, SPRAY (81104-017-03) 2026-01-16 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 81104-0017-03?
NDC 81104-0017-03 contains 75 mL — 75 ml in 1 bottle, spray.
What is the difference between NDC 81104-0017-03 and NDC 81104-0017-01?
Both are Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum Avobenzone, Homosalate, Octisalate, Octocrylene 3 g/100mL; 5 g/100mL; 5 g/100mL; 10 g/100mL Spray — the drug itself is identical. NDC 81104-0017-03 is the 75 mL package, while NDC 81104-0017-01 is the 30 ml package.
What NDC number is used to bill for this package of Hydrating Glow Mist with Pentavitin SPF 50 Broad Spectrum Avobenzone, Homosalate, Octisalate, Octocrylene 3 g/100mL; 5 g/100mL; 5 g/100mL; 10 g/100mL Spray?
Bill NDC 81104-0017-03 — the 11-digit billing format is 81104001703. 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 — Not published for this NDC No photo available yet for this listing.
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 81104-017-03, 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: 81104-0017-03, written without dashes as 81104001703. 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 81104-0017-03, the first segment (81104) is the labeler code FDA assigned to NAKED SUNDAYS PTY LTD; the middle segment (0017) 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 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 1 other package presentation of this same product, including 30 ml (81104-0017-01). 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 🧪 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 aging caused by the sun

⏱️ Dosage and Administration 138 words ▾

Directions shake well before use Avoid eye area use as top up sunscreen only hold 8-10" away from your body and spray liberally & evenly until skin feels moist 20 minutes before sun exposure Do not apply in windy conditions Use in a well-ventilated area Avoid inhalation Reapply at least every 2 hours Reapply immediately after swimming, sweating or towel drying. Use a water resistant sunscreen if swimming or sweating. 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 79 words ▾

Warnings For external use only. Flammable: Keep away from flames and sparks. Wait 5/10 minutes after application before approaching a source of heat or flame, or before smoking 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 10 words ▾

Active Ingredients Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 5%

🧪 Inactive Ingredients 35 words ▾

Inactive Ingredients Citric Acid, Citrullus Lanatus (Watermelon) Seed Oil, Fragrance, Glycerin, Potassium Sorbate, SD Alcohol 40-B, Saccharide Isomerate, Sodium Benzoate, Sodium Citrate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

🎯 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 ↗
← 81104-0015-03 · NAKED 81104-0100-01 · 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.