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Lip Conditioner SPF 15 Merle Norman OCTINOXATE,OCTISALATE .278 g/3.7g; .185 g/3.7g Jelly, 1 tube — NDC 57627-0107-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lip Conditioner SPF 15 Merle Norman OCTINOXATE,OCTISALATE .278 g/3.7g; .185 g/3.7g Jelly, 1 tube — NDC 57627-107-02 (Billing 57627-0107-02)

by Merle Norman Cosmetics, Inc · 1 TUBE in 1 CARTON / 3.7 g in 1 TUBE

This is a package of 1 tube of Lip Conditioner SPF 15 Merle Norman OCTINOXATE,OCTISALATE .278 g/3.7g; .185 g/3.7g Jelly from Merle Norman Cosmetics, Inc, marketed since Apr 2011 and currently FDA-listed. It is this product's only package size.

NDC 57627-0107-02
🏷️ FDA NDC (as labeled) 57627-107-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57627-107-02
Product NDC 57627-107
11-digit billing NDC 57627010702
UNII 4Y5P7MUD51, 4X49Y0596W
UPC 0885682277601
Application # M020
SPL Set ID b28459dc-c2df-4f8b-8b37-0090e223e6e9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-04-21
Route TOPICAL
Dosage form JELLY
Substance OCTINOXATE; OCTISALATE
Why two NDCs? The FDA registers this code as 57627-107-02 — 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 → 57627-0107-02. 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.

Clinical

🧪 What is this product?

This is a topical lip jelly that functions as a sunscreen product. It contains two active ingredients, octinoxate and octisalate, which are ultraviolet (UV) filters commonly used in over-the-counter sunscreen products to help protect the lips from sun exposure. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and effectiveness rules for sunscreen products rather than being individually approved through a separate 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.

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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
57627-0107-02 You're viewing this Main listing 1 TUBE in 1 CARTON / 3.7 g in 1 TUBE 2011-04-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lip Conditioner SPF 15 Merle Norman .278 g/3.7g; .185 g/3.7gthis 57627-0107-02 Merle 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

🏛️
2011
On the market since
Apr 2011
📍
2026
Currently FDA-listed
15 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.

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 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 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 WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII Q1LS2UJO3A
    Ceresin is a purified mineral wax derived from ozocerite. It functions as a binding agent, thickener, and coating material in medicines to help hold ingredients together and provide texture or protective coating.
  • UNII UYH3R74N56
    A natural fat derived from African palm fruit, used as an emollient and binder to help hold tablet or capsule ingredients together and improve texture and spreadability in topical and oral formulations.
  • UNII 42DG15CHXV
    A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
  • UNII 515610SU8C
    Macadamia oil is a plant-derived oil extracted from macadamia nuts. In medicines, it serves as an emollient and solvent to help dissolve or suspend active ingredients and improve product texture and absorption.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • 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 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.

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

The official label also statesInactive Ricinus communis (castor) seed oil, macadamia ternifolia seed oil, ozokerite, euphorbia cerifera (candelilla) wax, copernicia cerifera (carnauba) wax, astrocaryum murumuru seed butter, isopropyl lanolate, jojoba esters, wheat germ glycerides, oleyl alcohol, isodecyl oleate, butyspermum parkii (shea) butter, elaeis guineensis (palm) butter, punica granatum extract, acacia decurrens flower wax, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed wax, jojoba oil, c12-15 alkyl benzoate, polyglyceryl-3 esters, polyhydroxystearic acid, stearic acid, BHT, aluminum oxide, titanium dioxide, Fragrance (parfum) 030411

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.

Manufacturer & labeler

LabelerMerle Norman Cosmetics, Inc
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code57627
First marketedApr 2011
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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

· Stop use and ask a doctor if rash occurs and persists

⏱️ Dosage and Administration 36 words ▾

Directions · Apply liberally 15 minutes before sun exposure · Reapply at least every 2 hours · Use a water resistant sunscreen if swimming or sweating · Children under 6 months of age: Ask a doctor

⚠️ Warnings 66 words ▾

WARNINGS Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. 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 ~1 min read ▾

Active ingredients Purpose OCTINOXATE 7.5% Sunscreen OCTISALATE 5.0% Sunscreen Uses · helps prevent sunburn · Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. · Stop use and ask a doctor if rash occurs and persists WARNINGS Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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. Directions · Apply liberally 15 minutes before sun exposure · Reapply at least every 2 hours · Use a water resistant sunscreen if swimming or sweating · Children under 6 months of age: Ask a doctor Inactive Ricinus communis ( castor) seed oil, macadamia ternifolia seed oil, ozokerite, euphorbia cerifera ( candelilla) wax, copernicia cerifera ( carnauba) wax, astrocaryum murumuru seed butter, isopropyl lanolate, jojoba esters, wheat germ glycerides, oleyl alcohol, isodecyl oleate, butyspermum parkii (shea ) butter, elaeis guineensis (palm) butter, punica granatum extract, acacia decurrens flower wax, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed wax, jojoba oil, c12-15 alkyl benzoate, polyglyceryl-3 esters, polyhydroxystearic acid, stearic acid, BHT, aluminum oxide, titanium dioxide, Fragrance (parfum) 030411

🧪 Inactive Ingredients 82 words ▾

Inactive Ricinus communis ( castor) seed oil, macadamia ternifolia seed oil, ozokerite, euphorbia cerifera ( candelilla) wax, copernicia cerifera ( carnauba) wax, astrocaryum murumuru seed butter, isopropyl lanolate, jojoba esters, wheat germ glycerides, oleyl alcohol, isodecyl oleate, butyspermum parkii (shea ) butter, elaeis guineensis (palm) butter, punica granatum extract, acacia decurrens flower wax, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed wax, jojoba oil, c12-15 alkyl benzoate, polyglyceryl-3 esters, polyhydroxystearic acid, stearic acid, BHT, aluminum oxide, titanium dioxide, Fragrance (parfum) 030411

🎯 Purpose 5 words ▾

Uses · helps prevent sunburn

📄 Keep Out of Reach of Children 22 words ▾

· Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 13 words ▾

Lip Conditioner SPF 15 Merle Norman 3.7 g net. wt. .13 oz. Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
← 57619-0307-01 · LABORATORIOS 57627-0108-02 · 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.