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glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30 23 g/100g Lotion — NDC 60541-6000-05 package photo

glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30 23 g/100g Lotion

by Hayden Caleel LLC · 1 TUBE in 1 CARTON (60541-6000-5) / 50 g in 1 TUBE
NDC 60541-6000-05
🏷️ FDA NDC (as labeled) 60541-6000-5 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) 60541-6000-5
Product NDC 60541-6000
11-digit billing NDC 60541600005
UNII SOI2LOH54Z
Application # M020
SPL Set ID 00bf7331-c9dc-4a8a-9ff3-901e0d07eac6
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 2025-01-15
Route TOPICAL
Dosage form LOTION
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 60541-6000-5 — 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 → 60541-6000-05. 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

LabelerHayden Caleel LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code60541
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio9 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 oil-free tinted lotion applied to the skin that functions as a cosmetic primer and sunscreen. The active ingredient, zinc oxide, is commonly used as a broad-spectrum ultraviolet light filter in sunscreen products. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness standards for sunscreen ingredients rather than undergoing individual product approval. It is intended to be used topically on 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII XHK3U310BA
    Cyclohexasiloxane is a silicon-based liquid that acts as a solvent and conditioning agent in medicines. It helps dissolve or carry other ingredients and improves how the product spreads or feels on the skin.
  • UNII 0THT5PCI0R
    A silicone-based liquid that helps distribute active ingredients evenly throughout topical products. It acts as a solvent and emollient, allowing medicines to spread smoothly on skin while improving texture and absorption.
  • 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 4CG9F9W01Q
    A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 06R6X77P9C
    A silicone-based lubricant made by combining polyethylene glycol, polypropylene glycol, and dimethicone. It reduces friction and stickiness in tablet or capsule formulations to improve manufacturing and swallowing.
  • 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 46P231IQV8
    A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
  • UNII 59Z907ZB69
    A synthetic silicone polymer used as a glidant and anti-caking agent. It reduces friction between particles, helping powders and tablets flow smoothly during manufacturing and use.
  • UNII F8DRP5BB29
    A silicone-based polymer that acts as an emulsifier and skin-conditioning agent. It helps blend oil and water ingredients together and improves the texture and feel of topical formulations.
  • 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 O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • 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.

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

The official label also statesIsododecane, Cyclopentasiloxane, Hexyl Laurate, Cyclohexasiloxane, Polysilicone-11, Polymethylsilsesquioxane, Mica, Bisabolol, Water, Triethoxycaprylylsilane, PEG/PPG-20/15 Dimethicone, Niacinamide, Tetrahexyldecyl Ascorbate, Maris Aqua/Sea Water/Eau de Mer, Glycerin, Polyglyceryl-3 Diisostearate, Phenoxyethanol, Saccharide Isomerate, Salicylic Acid, Titanium Dioxide, Iron Oxides

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.
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
glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30 23 g/100gthis 60541-6000-05 Hayden 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

🏛️
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
60541-6000-05 You're viewing this 1 TUBE in 1 CARTON (60541-6000-5) / 50 g in 1 TUBE 2025-01-15 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 60541-6000-5, 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: 60541-6000-05, written without dashes as 60541600005. 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 60541-6000-05, the first segment (60541) is the labeler code FDA assigned to Hayden Caleel LLC; the middle segment (6000) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Hayden Caleel LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hayden Caleel 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 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 99 words ▾

Directions • apply generously 15 minutes before sun exposure • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • 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 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: Ask a doctor

⚠️ Warnings 54 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 docor if rash occurs Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredients Zinc Oxide 23%

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients Isododecane, Cyclopentasiloxane, Hexyl Laurate, Cyclohexasiloxane, Polysilicone-11, Polymethylsilsesquioxane, Mica, Bisabolol, Water, Triethoxycaprylylsilane, PEG/PPG-20/15 Dimethicone, Niacinamide, Tetrahexyldecyl Ascorbate, Maris Aqua/Sea Water/Eau de Mer, Glycerin, Polyglyceryl-3 Diisostearate, Phenoxyethanol, Saccharide Isomerate, Salicylic Acid, Titanium Dioxide, Iron Oxides

🎯 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 ↗
← 60541-2100-01 · Hayden 60546-0001-01 · At →
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.