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Soft Bisque Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide 4 g/100g; 5.2 g/100g Cream — NDC 57627-0163-02 package photo

Soft Bisque Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide 4 g/100g; 5.2 g/100g Cream

by Merle Norman Cosmetics, Inc · 1 BOTTLE in 1 CARTON (57627-163-02) / 17 g in 1 BOTTLE (57627-163-01)
NDC 57627-0163-02
🏷️ FDA NDC (as labeled) 57627-163-02 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 20, 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) 57627-163-02
Product NDC 57627-163
11-digit billing NDC 57627016302
UNII 4Y5P7MUD51, 15FIX9V2JP
Application # M020
SPL Set ID ff396aca-cf64-45f8-ba2e-c4fc55d6484b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-10-20
Route TOPICAL
Dosage form CREAM
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 57627-163-02 — 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 → 57627-0163-02. 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 marketedOct 2013
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?

Soft Bisque Expert Finish Makeup Broad Spectrum SPF 25 is a topical cream makeup product that functions as an over-the-counter sunscreen. It contains two active ingredients that work together as UV filters: octinoxate and titanium dioxide. These mineral and chemical UV-absorbing agents are typically used to help protect skin from ultraviolet (UV) rays. This product is marketed under the FDA's over-the-counter monograph rules for sunscreen-active cosmetics rather than as an individually approved drug application.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 I9PJ0O6294
    A modified starch derived from corn or potato starch with aluminum salt and octenylsuccinic acid added. It acts as a binder to hold tablet ingredients together and as a thickening agent in liquid formulations.
  • UNII 12V64UPU6R
    A plant-based fat extracted from murumuru palm seeds. It acts as an emollient and thickener in topical formulations, helping create smooth texture and improve skin feel in creams and lotions.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII U4AS1BW4ZB
    Cetyl dimethicone is a silicone-based lubricant and emollient. It helps the medicine spread smoothly, reduces friction between particles, and improves the product's texture and feel.
  • 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 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 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 UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • UNII S4V5BS6GCX
    A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
  • UNII 411THY156Q
    Isostearyl neopentanoate is a synthetic oily substance used as an emollient and skin-conditioning agent in topical medicines. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII 113171Q70B
    Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
  • UNII 446U8J075B
    Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
  • UNII 35V6A8JW8E
    A chemical compound used as a buffer and pH regulator in medications. It helps maintain the proper acidity level of the medicine to improve stability and ensure the active ingredients work as intended.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • 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 6W9PS8B71J
    Sorbitan monolaurate is a natural oil-derived emulsifier made from sorbitol and lauric acid. It helps mix oils and water-based ingredients together in the medicine so the formula stays uniform and smooth.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

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

The official label also statesInactive Ingredients Isononyl Isononanoate, Ethylhexyl Palmitate, Polyethylene, Nylon-12, C12-15 Alkyl Benzoate, Lauroyl Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Talc, Isostearyl Neopentanoate, Astrocaryum Murumuru Seed Butter, Cetyl Dimethicone, Silica, Aluminum Starch Octenylsuccinate, Copernicia Cerifera (Carnauba) Wax, Dimethicone, Tocopheryl Acetate, Polyhydroxystearic Acid, Stearic Acid, Polyurethane-40, Sorbitan Oleate, Sorbitan Laurate, Myristyl Malate Phosphonic Acid, BHT Aluminum Oxide, May Contain, Iron Oxides, Titanium Dioxide

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
Alabaster Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0160-02 Merle 1 bottle — — FDA listed —
Ivory Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0169-02 Merle 1 bottle — — FDA listed —
Simply Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0162-02 Merle 1 bottle — — FDA listed —
Medium Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0165-02 Merle 1 bottle — — FDA listed —
Sandy Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0166-02 Merle 1 bottle — — FDA listed —
Creamy Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0161-02 Merle 1 bottle — — FDA listed —
Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0157-02 Merle 1 bottle — — FDA listed —
Porcelain Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0159-02 Merle 1 bottle — — FDA listed —
Delicate Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0167-02 Merle 1 bottle — — FDA listed —
Sand Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100g 57627-0164-02 Merle 1 bottle — — FDA listed —
Soft Bisque Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman 4 g/100g; 5.2 g/100gthis 57627-0163-02 Merle 1 bottle — — 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

🏛️
2013
On the market since
Oct 2013
📍
2026
Currently FDA-listed
13 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
57627-0163-02 You're viewing this 1 BOTTLE in 1 CARTON (57627-163-02) / 17 g in 1 BOTTLE (57627-163-01) 2013-10-20 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 57627-163-02, 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: 57627-0163-02, written without dashes as 57627016302. 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 57627-0163-02, the first segment (57627) is the labeler code FDA assigned to Merle Norman Cosmetics, Inc; the middle segment (0163) 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 9 words ▾

Stop use and ask a doctor if rash occurs

⏱️ Dosage and Administration 96 words ▾

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, 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 sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor

⚠️ Warnings 26 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.

🧪 Active Ingredient 10 words ▾

Active Ingredients Purpose Octinoxate 4.0% Sunscreen Titanium Dioxide 5.2% Sunscreen

🧪 Inactive Ingredients 59 words ▾

Inactive Ingredients Isononyl Isononanoate, Ethylhexyl Palmitate, Polyethylene, Nylon-12, C12-15 Alkyl Benzoate, Lauroyl Lysine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Talc, Isostearyl Neopentanoate, Astrocaryum Murumuru Seed Butter, Cetyl Dimethicone, Silica, Aluminum Starch Octenylsuccinate, Copernicia Cerifera (Carnauba) Wax, Dimethicone, Tocopheryl Acetate, Polyhydroxystearic Acid, Stearic Acid, Polyurethane-40, Sorbitan Oleate, Sorbitan Laurate, Myristyl Malate Phosphonic Acid, BHT Aluminum Oxide, May Contain, Iron Oxides, Titanium Dioxide

🎯 Purpose 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 57627-0162-02 · Merle 57627-0164-02 · Merle →
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.