ILLUSION LUMINOUS GLOW FOUNDATION avobenzone, homosalate, and octisalate 3 g/100mL; 7.34 g/100mL; 5 g/100mL Lotion — NDC 42627-0102-23 package photo

ILLUSION LUMINOUS GLOW FOUNDATION avobenzone, homosalate, and octisalate 3 g/100mL; 7.34 g/100mL; 5 g/100mL Lotion

by Kingdom Animalia, LLC DBA Hourglass Cosmetics · 1 TUBE in 1 CARTON (42627-102-23) / 35 mL in 1 TUBE
NDC 42627-0102-23
🏷️ FDA NDC (as labeled) 42627-102-23 billing pads the product segment with a zero
This package
Contains35 mL in 1 tube Pack sizes32 compare ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 42627-102-23
Product NDC 42627-102
11-digit billing NDC 42627010223
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W
Application # M020
SPL Set ID cf6a7e1a-7bca-439c-808a-80262f095f84
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-01
Route TOPICAL
Dosage form LOTION
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Why two NDCs? The FDA registers this code as 42627-102-23 — 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 → 42627-0102-23. 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

LabelerKingdom Animalia, LLC DBA Hourglass Cosmetics
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code42627
First marketedDec 2024
Product typeHuman Otc Drug
Portfolio2 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?

Illusion Luminous Glow Foundation is a topical lotion marketed as an over-the-counter sunscreen product under FDA's monograph rules. It contains three active ingredients: avobenzone, homosalate, and octisalate, which are ultraviolet (UV) filters commonly used in sunscreen lotions to help absorb or scatter UV radiation from the sun. This product is intended to be applied to the skin as a cosmetic foundation with sun-protective properties.

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.

💊 What it looks like

Color Brown
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 J2KA067N9O
    A waxy substance derived from myristic acid and aluminum. It acts as a lubricant and glidant to help powder flow smoothly during tablet manufacturing and prevent sticking.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • 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 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 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 1E5KJY107T
    A liquid mixture derived from coconut oil, coconut alkanes serve as a solvent and lubricant in medicines. They help dissolve active ingredients and reduce friction during manufacturing and tablet compression.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 77JZM5516Z
    A liquid oil derived from coconut sources, used as a solvent and emollient to help dissolve active ingredients and improve how the medicine spreads or absorbs in the formulation.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 2P2G24V6T9
    A silicone-based ingredient that acts as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression. It reduces friction and prevents clumping in the final product.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 45ASM2L11M
    A synthetic ingredient derived from glutamic acid and stearic acid. It acts as an emulsifier and surfactant, helping oils and water mix smoothly in the medication formulation.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII XQQ9MKE2BJ
    Eicosyl povidone is a synthetic polymer derived from povidone with added long-chain fatty components. It functions as a solubilizer and absorption enhancer to help the medicine dissolve better and be absorbed more effectively by the body.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 73CJJ317SR
    A waxy substance derived from plant oils, used as a binder and lubricant to help hold tablet ingredients together and improve how the medicine flows during manufacturing.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • 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 LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • 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 7B8OE71MQC
    A synthetic emulsifier derived from glycerin and fatty acids. It helps oils and water mix together in formulations, keeping ingredients evenly distributed throughout the product.
  • UNII 687U3PEB2Y
    A complex emulsifier made from glycerin and fatty acids. It helps blend oil and water-based ingredients together and improves the texture and stability of creams, lotions, and other formulated products.
  • UNII YPM0ZOC2HR
    A synthetic emulsifier derived from glycerin and castor oil. It helps mix oil and water-based ingredients together in the formulation to create a uniform product and improve texture.
  • 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 EU2PSP0G0W
    Silica dimethyl silylate is a silicon-based powder that acts as a glidant and anti-caking agent. It reduces friction between particles and helps powders flow smoothly during manufacturing and tablet compression.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 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 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • 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 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 8OC9U7TQZ0
    Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.
  • 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.

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

The official label also statesWATER/AQUA, BUTYLOCTYL SALICYLATE, COCONUT ALKANES, DIMETHICONE, TRIBEHENIN, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, DICAPRYLYL ETHER, CETYL ALCOHOL, POLYGLYCERYL-6 POLYRICINOLEATE, SILICA, ETHYLHEXYL PALMITATE, GLYCERIN, OCTYLDODECYL NEOPENTANOATE, SODIUM CHLORIDE, SORBITAN OLEATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYGLYCERYL-2 ISOSTEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, CETEARYL ALCOHOL, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, VP/EICOSENE COPOLYMER, ETHYLHEXYLGLYCERIN, POTASSIUM SORBATE, SODIUM BENZOATE, COCOCAPRYLATE/CAPRATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL DIBEHENATE, ALUMINUM DIMYRISTATE, TRIETHOXYCAPRYLYLSILANE, CITRIC ACID, DISODIUM STEAROYL GLUTAMATE, GLYCERYL BEHENATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, METHYL SALICYLATE, PHENOXYETHANOL, SODIUM CITRATE, SODIUM HYALURONATE, TOCOPHEROL, HEXYLENE GLYCOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

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
Illusion Luminous Glow Foundation 3 g/100mL; 7.34 g/100mL; 5 g/100mLthis 42627-0102-23 Kingdom 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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 ILLUSION LUMINOUS GLOW FOUNDATION (this brand).

Top reported reactions

Anaphylactic Reaction1
Hypersensitivity1

Reporter sex

1 reports
Female · 100%
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
42627-0102-01 1 TUBE in 1 CARTON (42627-102-01) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-02 1 TUBE in 1 CARTON (42627-102-02) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-03 1 TUBE in 1 CARTON (42627-102-03) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-04 1 TUBE in 1 CARTON (42627-102-04) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-05 1 TUBE in 1 CARTON (42627-102-05) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-06 1 TUBE in 1 CARTON (42627-102-06) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-07 1 TUBE in 1 CARTON (42627-102-07) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-08 1 TUBE in 1 CARTON (42627-102-08) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-09 1 TUBE in 1 CARTON (42627-102-09) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-10 1 TUBE in 1 CARTON (42627-102-10) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-11 1 TUBE in 1 CARTON (42627-102-11) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-12 1 TUBE in 1 CARTON (42627-102-12) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-13 1 TUBE in 1 CARTON (42627-102-13) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-14 1 TUBE in 1 CARTON (42627-102-14) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-15 1 TUBE in 1 CARTON (42627-102-15) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-16 1 TUBE in 1 CARTON (42627-102-16) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-17 1 TUBE in 1 CARTON (42627-102-17) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-18 1 TUBE in 1 CARTON (42627-102-18) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-19 1 TUBE in 1 CARTON (42627-102-19) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-20 1 TUBE in 1 CARTON (42627-102-20) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-21 1 TUBE in 1 CARTON (42627-102-21) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-22 1 TUBE in 1 CARTON (42627-102-22) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-23 You're viewing this 1 TUBE in 1 CARTON (42627-102-23) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-24 1 TUBE in 1 CARTON (42627-102-24) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-25 1 TUBE in 1 CARTON (42627-102-25) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-26 1 TUBE in 1 CARTON (42627-102-26) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-27 1 TUBE in 1 CARTON (42627-102-27) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-28 1 TUBE in 1 CARTON (42627-102-28) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-29 1 TUBE in 1 CARTON (42627-102-29) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-30 1 TUBE in 1 CARTON (42627-102-30) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-31 1 TUBE in 1 CARTON (42627-102-31) / 35 mL in 1 TUBE 2024-12-01 Active
42627-0102-32 1 TUBE in 1 CARTON (42627-102-32) / 35 mL in 1 TUBE 2024-12-01 Active

Pack size FAQ

What quantity is in NDC 42627-0102-23?
NDC 42627-0102-23 is listed by the FDA — 1 tube in 1 carton / 35 ml in 1 tube.
What NDC number is used to bill for this package of ILLUSION LUMINOUS GLOW FOUNDATION avobenzone, homosalate, and octisalate 3 g/100mL; 7.34 g/100mL; 5 g/100mL Lotion?
Bill NDC 42627-0102-23 — the 11-digit billing format is 42627010223. 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 42627-102-23, 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: 42627-0102-23, written without dashes as 42627010223. 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 42627-0102-23, the first segment (42627) is the labeler code FDA assigned to Kingdom Animalia, LLC DBA Hourglass Cosmetics; the middle segment (0102) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (23) 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 Kingdom Animalia, LLC DBA Hourglass Cosmetics. 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 31 other package presentations of this same product, including 1 tube (42627-0102-01), 1 tube (42627-0102-02), 1 tube (42627-0102-03). 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?
Kingdom Animalia, LLC DBA Hourglass Cosmetics 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 30 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 89 words

Directions Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.

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 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-sleeve shirts, pants, hats and sunglasses.

Children under 6 months: Ask a doctor.

⚠️ Warnings 56 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 product is swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words

Other Information Protect this product from excessive heat and direct sun.

🧪 Active Ingredient 8 words

Active Ingredients Avobenzone 3.0% Homosalate 7.34% Octisalate 5.0%

🧪 Inactive Ingredients 93 words

Inactive Ingredients WATER/AQUA, BUTYLOCTYL SALICYLATE, COCONUT ALKANES, DIMETHICONE, TRIBEHENIN, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, DICAPRYLYL ETHER, CETYL ALCOHOL, POLYGLYCERYL-6 POLYRICINOLEATE, SILICA, ETHYLHEXYL PALMITATE, GLYCERIN, OCTYLDODECYL NEOPENTANOATE, SODIUM CHLORIDE, SORBITAN OLEATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYGLYCERYL-2 ISOSTEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, CETEARYL ALCOHOL, DISTEARDIMONIUM HECTORITE, CAPRYLYL GLYCOL, VP/EICOSENE COPOLYMER, ETHYLHEXYLGLYCERIN, POTASSIUM SORBATE, SODIUM BENZOATE, COCOCAPRYLATE/CAPRATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL DIBEHENATE, ALUMINUM DIMYRISTATE, TRIETHOXYCAPRYLYLSILANE, CITRIC ACID, DISODIUM STEAROYL GLUTAMATE, GLYCERYL BEHENATE, SILICA DIMETHYL SILYLATE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, METHYL SALICYLATE, PHENOXYETHANOL, SODIUM CITRATE, SODIUM HYALURONATE, TOCOPHEROL, HEXYLENE GLYCOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

🎯 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.