Timeless Illuminating Makeup SPF 30 Alabaster Merle Norman Octinoxate, Oxybenzone 7.5 g/100mL; 2 g/100mL Cream
by Merle Norman Cosmetics, Inc · 1 BOTTLE in 1 CARTON (57627-177-02) / 30 mL in 1 BOTTLE (57627-177-01)
NDC 57627-0177-02
🏷️ FDA NDC (as labeled)
57627-177-02
billing pads the product 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 →
🆔 Identity & classification
FDA NDC (as labeled)
57627-177-02
Product NDC
57627-177
11-digit billing NDC
57627017702
UNII
4Y5P7MUD51, 95OOS7VE0Y
Application #
M020
SPL Set ID
d54a35a2-4f5d-4aec-8be4-1d8e00d4618f
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2017-01-24
Route
TOPICAL
Dosage form
CREAM
Substance
OCTINOXATE; OXYBENZONE
Why two NDCs?
The FDA registers this code as 57627-177-02 — 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 → 57627-0177-02. 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
LabelerMerle Norman Cosmetics, Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code57627
First marketedJan 2017
Product typeHuman Otc Drug
Portfolio48 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?
Timeless Illuminating Makeup SPF 30 Alabaster is a topical cream cosmetic foundation that functions as a sunscreen. It contains two UV-filtering ingredients, octinoxate and oxybenzone, which are commonly used in over-the-counter sunscreen products to absorb ultraviolet radiation. This product is marketed under the FDA's over-the-counter monograph rules for sunscreen cosmetics rather than as an individually approved drug application.
Patient education
Supplement & herbal interactions
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.
💬 Questions about Octinoxate, Oxybenzone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII LMI26O6933
Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
-
UNII 25BB7EKE2E
Barium sulfate is a white powder mineral compound used as a filler and opacifying agent in tablets and capsules. It adds bulk to the medicine and may be included in formulations for imaging purposes.
-
UNII 4ZR792I587
Bismuth oxychloride is a white powder derived from bismuth metal. In medicines, it's used mainly as a colorant and opacifying agent to give tablets or capsules their appearance and to make liquid formulations less transparent.
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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.
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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 Q95M2P1KJL
A silicone-based ingredient that acts as a lubricant and glidant. It helps the tablet or capsule move smoothly through manufacturing equipment and improves powder flow during production.
-
UNII V2W71V8T0X
A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
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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 89B2BSF9I3
A synthetic compound made by chemically combining corn dextrin (a starch derivative) with palmitic acid. It acts as a binder and flow agent, helping hold tablet ingredients together and improve powder handling during manufacturing.
-
UNII A1A1I8X02B
A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
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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.
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UNII MP1J8420LU
A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
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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.
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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 G7036X8B5H
A dark iron compound that gives medicine its color. Used as a colorant in tablets and capsules to help identify the medication and make it visually distinctive.
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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 79Y1949PYO
Gold is a precious metal used in some medications as an active therapeutic ingredient rather than a typical inactive filler. It may be included in certain formulations for its purported anti-inflammatory or immunomodulatory properties in specific medical treatments.
-
UNII WB5K9Y35Y9
A synthetic crosslinked polymer made by combining hexamethylene diisocyanate with trimethylol hexyllactone. It's used as a film-former and binder to help create protective coatings on tablets or capsules and improve product stability.
-
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 R33S7TK2EP
Hydroxyethyl cellulose is a thickening agent made from processed plant cellulose. It's used in medicines to increase viscosity, improve texture, and help distribute active ingredients evenly throughout liquid or semi-solid formulations.
-
UNII DE08037SAB
Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
-
UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
-
UNII S73ZQI0GXM
Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
-
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 TYP81E471F
A silicone-based lubricant and anti-foaming agent derived from dimethicone, a synthetic polymer. It helps reduce friction during tablet or capsule manufacturing and prevents excessive foam in liquid formulations.
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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.
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UNII DR0K5NOJ4R
Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
-
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 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 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 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
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 5041RX63GN
A synthetic silicon-based polymer used as a glidant and anti-caking agent. It helps powder particles flow smoothly and prevents clumping during manufacturing and storage.
-
UNII I39WR998BI
Ultramarine blue is a blue pigment derived from natural minerals or made synthetically. It's used in medicines as a colorant to give tablets, capsules, or other products their blue appearance.
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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.
38 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater/Aqua/Eau, Cyclopentasiloxane, Tiatnium Dioxide (CI 77891). Caprylic/Capric Triglyceride, Phenyl Trimethicone, Methyl Trimethicone, Aluminum Oxide, Lauryl PEG-10 Tris(Trimethylsiloxysiloxy)silyethyl Dimethicone, Trimethylsiloxysilicate, Dimethicone, Butylene Glycol, Glycerin, Gold, Palmitoyl Hexapeptide-14, Peat Extract, Diglucosyl Gallic Acid, Hydroxyethylcellulose, Saccharomyces/Xylinum/Black Tea Ferment, HDI/Trimethylol Hexyllactone Crosspolymer, Polymethylsilsesquioxane, Triethoxycaprylylsilane, Bis-Stearyl Dimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dextrin Palimitate, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-3Beeswax, Silica, Mica (CI 77019), Ethoxydiglycol, Magnesium Sulfate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Tetrasodium EDTA, Potassium Sorabate, Talc, May Contain Barium Sulfate (CI 77120), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77489, CI 77491, CI 77492, CI 77499), Ultramarines (CI 77007)
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 system | Per g | Per 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
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
🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 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 Octinoxate, Oxybenzone — the ingredient across all brands.
Top reported reactions
Reporter sex
Female · 100%
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 57627-0177-02 You're viewing this | 1 BOTTLE in 1 CARTON (57627-177-02) / 30 mL in 1 BOTTLE (57627-177-01) | 2017-01-24 | 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 | — 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 57627-177-02, 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: 57627-0177-02, written without dashes as 57627017702. 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 57627-0177-02, the first segment (57627) is the labeler code FDA assigned to Merle Norman Cosmetics, Inc; the middle segment (0177) 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 Merle Norman Cosmetics, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Merle Norman Cosmetics, Inc 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 ▾
Stop use and ask a doctor if rash occurs
⏱️ Dosage and Administration ▾
Directions For sunscreen use: apply liberally and evenly 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, regulary use a sunscreeen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit tim in the sun, especially from 10a.m. - 2p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor
⚠️ Warnings ▾
Warnings For external use only Do not use on domaged or broken skin When using this product keep out of eyes. Rinse with water to remove.
🧪 Inactive Ingredients ▾
Water/Aqua/Eau, Cyclopentasiloxane, Tiatnium Dioxide (CI 77891). Caprylic/Capric Triglyceride, Phenyl Trimethicone, Methyl Trimethicone, Aluminum Oxide, Lauryl PEG-10 Tris(Trimethylsiloxysiloxy)silyethyl Dimethicone, Trimethylsiloxysilicate, Dimethicone, Butylene Glycol, Glycerin, Gold, Palmitoyl Hexapeptide-14, Peat Extract, Diglucosyl Gallic Acid, Hydroxyethylcellulose, Saccharomyces/Xylinum/Black Tea Ferment, HDI/Trimethylol Hexyllactone Crosspolymer, Polymethylsilsesquioxane, Triethoxycaprylylsilane, Bis-Stearyl Dimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dextrin Palimitate, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-3Beeswax, Silica, Mica (CI 77019), Ethoxydiglycol, Magnesium Sulfate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol, Tetrasodium EDTA, Potassium Sorabate, Talc, May Contain Barium Sulfate (CI 77120), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77489, CI 77491, CI 77492, CI 77499), Ultramarines (CI 77007)
🎯 Purpose ▾
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
No label section mentions that — try another word, or open the full label on DailyMed below.
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.