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Ciele lip and PROTECT lipstick SPF 60 Bonnie 15 g/100g Lipstick, 1 tube — NDC 83103-5000-01 package photo

Ciele lip and PROTECT lipstick SPF 60 Bonnie 15 g/100g Lipstick, 1 tube

by LE COSMETICS INC · 1 TUBE in 1 PACKAGE (83103-5000-1) / 3.5 g in 1 TUBE
NDC 83103-5000-01
🏷️ FDA NDC (as labeled) 83103-5000-1 billing pads the package segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through May 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 83103-5000-1
Product NDC 83103-5000
11-digit billing NDC 83103500001
UNII SOI2LOH54Z
UPC 0850082259014
Application # M020
SPL Set ID 513a0449-5494-5dfd-e063-6394a90a026e
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through May 2026)
Marketing start 2026-05-07
Route TOPICAL
Dosage form LIPSTICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 83103-5000-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 83103-5000-01. 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

LabelerLE COSMETICS INC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code83103
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio30 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?

Ciele Lip and Protect Lipstick SPF 60 is a topical lip balm product containing zinc oxide as its active ingredient. Zinc oxide is commonly used in sunscreen formulations as a mineral UV filter that reflects ultraviolet light away from the skin. This lipstick is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness guidelines for sunscreen products in lipstick form. The SPF 60 rating indicates the level of sun protection the product is intended to provide to the lips.

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 1N032N7MFO
    A brown-colored mineral form of iron oxide used as a colorant in tablets and capsules. It gives medicines their brown or tan appearance without affecting how the drug works.
  • 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 N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • 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 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 S3KFG6Q5X8
    An organic chemical compound used as a UV filter in topical formulations. It helps protect the medicine or product from degradation caused by sunlight exposure during storage and use.
  • 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 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 PL360EPO9J
    Soy sterol is a plant-derived fat extracted from soybeans. It's used as an emulsifier and stabilizer to help keep oil and water mixed together and maintain the medicine's texture and consistency.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 7F674YQ5SO
    A plant-derived wax made from hydrogenated jojoba oil. It serves as a lubricant and binder in tablets and capsules to improve how the medicine flows during manufacturing and to help hold ingredients together.
  • UNII 53839415GI
    A plant-based oil that has been chemically treated to make it solid at room temperature. It acts as a binder and lubricant to help hold tablet ingredients together and allow smooth manufacturing.
  • UNII A2M91M918C
    A plant-based oil derived from soybeans that has been chemically hardened to make it solid or semi-solid at room temperature. It acts as a binder, filler, and lubricant to help hold the tablet together and allow it to move smoothly during manufacturing and packaging.
  • UNII 72M48QQV8Q
    Manganese violet is a synthetic purple pigment made from manganese and other compounds. It's used as a colorant in medicines to make tablets or capsules visually distinctive for identification purposes.
  • UNII 7666FJ0J9F
    A rosin-derived compound used as a film-coating agent and binder in tablets and capsules. It helps create a protective layer around the medication and improves tablet hardness.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 481744AI4O
    A synthetic red dye used to color medicines and products. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII ECW0LZ41X8
    A synthetic red dye used to color tablets and capsules. It helps make medicines visually distinctive so patients can easily identify their medication.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 50XT325OOH
    A synthetic ester derived from citric acid and fatty alcohols. It acts as a plasticizer and emollient in the medicine, helping soften and improve the flexibility of coatings and formulations.

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

The official label also statesHelianthus Annuus (Sunflower) Seed Oil, Triisostearyl Citrate, Hydrogenated Soybean Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Hydrogenated Olive Oil, Butyloctyl Slaicylate, Euphoria Cerifera (Candelilla) Wax, Copernicia Cerfiera (Carnuauba) Wax, Octyldodecanol, Ehtylhexyl Methoxylcrylene, Polyhydroxystearic Acid, Hydrogenated Jojoba Oil, Flavoe, Methyl Dhydroabietate, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexylglycerin, Caprylyl Glycol, Tocopheryl Acetate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Glycine Soya (Soybean) Sterols, MAY CONTAIN +/-: Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Manganese Violet (CI 77742), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 40 Lake (CI 16035), 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 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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ciele lip and PROTECT lipstick SPF 60 Bonnie 15 g/100gthis 83103-5000-01 LE 1 tube — — Discontinued —
Ciele lip and PROTECT lipstick SPF 60 Bonnie 15 g/100g 54594-0135-15 Delicate 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
83103-5000-01 You're viewing this 1 TUBE in 1 PACKAGE (83103-5000-1) / 3.5 g in 1 TUBE 2026-05-07 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 83103-5000-1, 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: 83103-5000-01, written without dashes as 83103500001. 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 83103-5000-01, the first segment (83103) is the labeler code FDA assigned to LE COSMETICS INC; the middle segment (5000) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
LE 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 31 words ▾

Uses ● helps prevent sunburn ● if used as directed with other sun protection meausres (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 101 words ▾

Directions •apply liberally15 minutes before sun exposure and as needed • reapply at least every 2 hours. • use a water resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: Ask a doctor

⚠️ Warnings 54 words ▾

Warnings For external use only Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a docor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredients Zinc Oxide 15%

🧪 Inactive Ingredients 97 words ▾

Inactive ingredients Helianthus Annuus (Sunflower) Seed Oil, Triisostearyl Citrate, Hydrogenated Soybean Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Hydrogenated Olive Oil, Butyloctyl Slaicylate, Euphoria Cerifera (Candelilla) Wax, Copernicia Cerfiera (Carnuauba) Wax, Octyldodecanol, Ehtylhexyl Methoxylcrylene, Polyhydroxystearic Acid, Hydrogenated Jojoba Oil, Flavoe, Methyl Dhydroabietate, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexylglycerin, Caprylyl Glycol, Tocopheryl Acetate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Glycine Soya (Soybean) Sterols, MAY CONTAIN +/-: Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Manganese Violet (CI 77742), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 40 Lake (CI 16035), 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 ↗
← 83103-4300-01 · LE 83103-5001-01 · LE →
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.