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(from DailyMed)

Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shades Zinc Oxide and Titanium Dioxide 75.5 mg/mL; 20 mg/mL Lipstick, 4 mL

by Noxell · 1 CONTAINER in 1 BLISTER PACK (22700-250-01) / 4 mL in 1 CONTAINER
NDC 22700-0250-01
🏷️ FDA NDC (as labeled) 22700-250-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 22700-250-01
Product NDC 22700-250
11-digit billing NDC 22700025001
UNII SOI2LOH54Z, 15FIX9V2JP
UPC 3616306374102
Application # M020
SPL Set ID 2cdbeb73-b805-f144-e063-6294a90a088d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-02
Route TOPICAL
Dosage form LIPSTICK
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 22700-250-01 — 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 → 22700-0250-01. 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

LabelerNoxell
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code22700
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio3 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?

Covergirl Clean Fresh Tinted Lip Balm is a topical lipstick product that contains zinc oxide and titanium dioxide as active ingredients. These mineral compounds are commonly used in sunscreen formulations to protect skin from ultraviolet (UV) radiation; together they function as physical UV filters. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for sunscreen lip balms rather than undergoing individual product review.

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 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 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII K4XZD9W99K
    A synthetic red colorant made by combining D&C Red No. 6 dye with barium salt. It's used to add or enhance the red color of tablets, capsules, and other medicines so they're easier to identify.
  • 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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII JQ6BLH9FR7
    FD&C Yellow No. 5 Aluminum Lake is a bright yellow colorant made by combining a synthetic dye with aluminum and other salts. It colors tablets and capsules to help identify the medication and make it visually distinctive.
  • 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 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 XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII 1NA5AO9GH7
    A synthetic polymer derived from petroleum, polybutene is used as a binder and lubricant in solid medications to help hold ingredients together and improve the tablet or capsule's flow during manufacturing.
  • 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 8D08K3S51E
    Propylene carbonate is a clear liquid solvent derived from propylene. It helps dissolve or suspend active ingredients in liquid medicines and can improve how well the product flows and mixes.
  • 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 OLX698AH5P
    A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.

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

The official label also statesYou Make Me Blush- Polybutene, Caprylic/Capric Triglyceride, Polyethylene, Cera Microcristallina/Microcrystalline Wax/Cire Microcrystalline, Mica, Stearalkonium Hectorite, Silica, Propylene Carbonate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Dicalcium Phosphate, [May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Iron Oxides (CI 77491, CI 77492, CI 77499), Red 7 Lake (CI 15850)]. Orange You A Cutie- Polybutene, Caprylic/Capric Triglyceride, Polyethylene, Cera Microcristallina/Microcrystalline Wax/Cire Microcrystalline, Mica, Stearalkonium Hectorite, Silica, Dicalcium Phosphate, Propylene Carbonate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, [May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410)].

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 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
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shades 75.5 mg/mL; 20 mg/mLthis 22700-0250-01 Noxell 4 ml 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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
22700-0250-01 You're viewing this 1 CONTAINER in 1 BLISTER PACK (22700-250-01) / 4 mL in 1 CONTAINER 2025-03-02 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 22700-250-01, 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: 22700-0250-01, written without dashes as 22700025001. 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 22700-0250-01, the first segment (22700) is the labeler code FDA assigned to Noxell; the middle segment (0250) 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.
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 Noxell. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Noxell 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 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

⏱️ Dosage and Administration 89 words

Directions For sunscreen use: Apply liberally 15 minutes before sun exposure. Use 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 15 or higher and other sun protection measure, including: limit time in the sun, especially from 10 a.m - 2 p.m. wear long-sleeved shirts, pants, hats and sunglassess. children under 6 months: Ask a doctor.

⚠️ Warnings 5 words

Warnings For external use only.

📦 Storage and Handling 11 words

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

🧪 Active Ingredient 8 words

Active Ingredients Zinc Oxide 7.55% Titanium Dioxide 2%

🧪 Inactive Ingredients 100 words

Inactive ingredients You Make Me Blush- Polybutene, Caprylic/Capric Triglyceride, Polyethylene, Cera Microcristallina/Microcrystalline Wax/Cire Microcrystalline, Mica, Stearalkonium Hectorite, Silica, Propylene Carbonate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Dicalcium Phosphate, [May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Iron Oxides (CI 77491, CI 77492, CI 77499), Red 7 Lake (CI 15850)]. Orange You A Cutie- Polybutene, Caprylic/Capric Triglyceride, Polyethylene, Cera Microcristallina/Microcrystalline Wax/Cire Microcrystalline, Mica, Stearalkonium Hectorite, Silica, Dicalcium Phosphate, Propylene Carbonate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, [May Contain/Peut Contenir/+/-: Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410)].

🎯 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.