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COLLAGEN GLOW MINERAL SUNSCREEN SPF 50 ZINC OXIDE 22.75 g/100mL Lotion, 20 mL — NDC 81104-0100-02 package photo

COLLAGEN GLOW MINERAL SUNSCREEN SPF 50 ZINC OXIDE 22.75 g/100mL Lotion, 20 mL

by NAKED SUNDAYS PTY LTD · 20 mL in 1 TUBE (81104-100-02)
NDC 81104-0100-02
🏷️ FDA NDC (as labeled) 81104-100-02 billing pads the product segment with a zero
This package
Contains20 mL Pack sizes2 compare ↓
Also comes in: 50 ml 81104-0100-01
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

⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 81104-100-02
Product NDC 81104-100
11-digit billing NDC 81104010002
UNII SOI2LOH54Z
UPC 0754590470865
Application # M020
SPL Set ID 388fb3db-29d2-bb29-e063-6394a90a4efb
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-01
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 81104-100-02 — 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 → 81104-0100-02. 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

LabelerNAKED SUNDAYS PTY LTD
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code81104
First marketedDec 2020
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 lotion sunscreen containing zinc oxide as its active ingredient. Zinc oxide is a mineral UV filter typically used in sunscreens to reflect and scatter ultraviolet rays away from the skin. The product is formulated as an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for sunscreen products rather than as an individually reviewed application. It is applied to the skin to provide sun protection.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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 2936P60TPX
    A plant extract from baobab tree seeds used as a natural thickener and emulsifier in medicines. It helps create the right texture and keeps ingredients mixed together in liquid or semi-solid formulations.
  • UNII 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • UNII 1394NXB9L6
    A plant-derived protein from soybeans that has been broken down into smaller pieces using enzymes. It acts as a binder and texture agent, helping hold ingredients together and improve the product's consistency and mouthfeel.
  • 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 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 84IVV0906Z
    A plant-based powder made from whole rice grains. It serves as a filler and binder to give the tablet or capsule its shape and structure.
  • UNII 9713Q0S7FO
    A synthetic emulsifier derived from polyethylene glycol and fatty acids. It helps blend water and oil-based ingredients together in the formulation, improving texture and 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 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 9DLQ4CIU6V
    Proline is an amino acid used in pharmaceutical formulations as a bulking agent and stabilizer. It helps maintain product stability and can improve the texture or consistency of medicines, particularly in powders and freeze-dried products.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII O1PB8EU98M
    Tricaprin is a naturally occurring fatty acid commonly derived from coconut or palm oil. In medications, it serves as an emulsifier and solubilizer, helping mix oil and water-based ingredients and improve how the body absorbs the active drug.
  • 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.

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

The official label also statesCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S),COCO-CAPRYLATE (UNII: 4828G836N6),EDETATE DISODIUM (UNII: 7FLD91C86K),GLUCONOLACTONE (UNII: WQ29KQ9POT),ADANSONIA DIGITATA SEED (UNII: 2936P60TPX), ORYZA SATIVA WHOLE (UNII: 84IVV0906Z),HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6),ISOSTEARIC ACID (UNII: X33R8U0062),TRICAPRIN (UNII: O1PB8EU98M),OCTYLDODECANOL (UNII: 461N1O614Y),PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO),POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) PROLINE (UNII: 9DLQ4CIU6V),WATER (UNII: 059QF0KO0R),SODIUM BENZOATE (UNII: OJ245FE5EU),SODIUM CHLORIDE (UNII: 451W47IQ8X),ETHYLHEXYLGLYCERIN (UNII: 147D247K3P),PHENOXYETHANOL (UNII: HIE492ZZ3T) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)

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: 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
Collagen Glow Mineral Sunscreen Spf 50 22.75 g/100mL 81104-0103-11 NAKED 50 ml — — FDA listed —
Collagen Glow Mineral Sunscreen Spf 50 22.75 g/100mLthis 81104-0100-02 NAKED 20 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

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 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 COLLAGEN GLOW MINERAL SUNSCREEN SPF 50 (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 272 82
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
81104-0100-01 50 mL in 1 TUBE (81104-100-01) 2020-12-01 Active
81104-0100-02 You're viewing this 20 mL in 1 TUBE (81104-100-02) 2025-08-28 Active

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

Pack size FAQ

What quantity is in NDC 81104-0100-02?
NDC 81104-0100-02 contains 20 mL — 20 ml in 1 tube.
What is the difference between NDC 81104-0100-02 and NDC 81104-0100-01?
Both are COLLAGEN GLOW MINERAL SUNSCREEN SPF 50 ZINC OXIDE 22.75 g/100mL Lotion — the drug itself is identical. NDC 81104-0100-02 is the 20 mL package, while NDC 81104-0100-01 is the 50 ml package.
What NDC number is used to bill for this package of COLLAGEN GLOW MINERAL SUNSCREEN SPF 50 ZINC OXIDE 22.75 g/100mL Lotion?
Bill NDC 81104-0100-02 — the 11-digit billing format is 81104010002. 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 81104-100-02, 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: 81104-0100-02, written without dashes as 81104010002. 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 81104-0100-02, the first segment (81104) is the labeler code FDA assigned to NAKED SUNDAYS PTY LTD; the middle segment (0100) 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 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 50 ml (81104-0100-01). 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 ageing caused by the sun.

⏱️ Dosage and Administration 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 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 59 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. CONTAINS SODIUM BENZOATE. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 7 words ▾

ACTIVE INGREDIENT ZINC OXIDE 22.75% Purpose Sunscreen

🧪 Inactive Ingredients 63 words ▾

INACTIVE INGREDIENTS CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ,COCO-CAPRYLATE (UNII: 4828G836N6) ,EDETATE DISODIUM (UNII: 7FLD91C86K),GLUCONOLACTONE (UNII: WQ29KQ9POT),ADANSONIA DIGITATA SEED (UNII: 2936P60TPX), ORYZA SATIVA WHOLE (UNII: 84IVV0906Z),HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6),ISOSTEARIC ACID (UNII: X33R8U0062),TRICAPRIN (UNII: O1PB8EU98M),OCTYLDODECANOL (UNII: 461N1O614Y),PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO),POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) PROLINE (UNII: 9DLQ4CIU6V),WATER (UNII: 059QF0KO0R),SODIUM BENZOATE (UNII: OJ245FE5EU),SODIUM CHLORIDE (UNII: 451W47IQ8X),ETHYLHEXYLGLYCERIN (UNII: 147D247K3P),PHENOXYETHANOL (UNII: HIE492ZZ3T) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)

🎯 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 ↗
← 81104-0017-01 · NAKED 81104-0102-11 · 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.