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Really Great Lip Shield Titanium Dioxide, Zinc Oxide 55 mg/g; 40 mg/g Stick, 1 cylinder — NDC 85585-0212-45 package photo

Really Great Lip Shield Titanium Dioxide, Zinc Oxide 55 mg/g; 40 mg/g Stick, 1 cylinder

by JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION · 1 CYLINDER in 1 CARTON (85585-212-45) / 4.5 g in 1 CYLINDER
NDC 85585-0212-45
🏷️ FDA NDC (as labeled) 85585-212-45 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 →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Titanium Dioxide, Zinc Oxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 85585-212-45
Product NDC 85585-212
11-digit billing NDC 85585021245
UNII SOI2LOH54Z, 15FIX9V2JP
UPC 0385585212452
Application # M020
SPL Set ID 36c1341d-fbf5-56a5-e063-6294a90aa045
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-05-26
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 85585-212-45 — 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 → 85585-0212-45. 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

LabelerJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85585
First marketedMay 2022
Product typeHuman Otc Drug
Portfolio4 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?

Really Great Lip Shield is a topical stick product containing titanium dioxide and zinc oxide, which are mineral sun-blocking agents. These ingredients are commonly used in lip balms and sunscreen products to reflect and scatter ultraviolet rays away from the skin. This is an over-the-counter monograph drug, meaning it is marketed under FDA guidelines for sunscreen products rather than as an individually approved 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.

💊 What it looks like

FlavorKiwi
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 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 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII U6XF9NP8HM
    Aluminum stearate is a salt made from aluminum and stearic acid, a fatty substance. It works as a lubricant and glidant to help powder flow smoothly during manufacturing and tablet production.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • 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 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 P5O01U99NI
    A synthetic oily substance used as an emollient and texture enhancer in topical medicines. It helps soften the skin, improve product spreadability, and maintain a smooth, non-greasy feel.
  • UNII 7LAB1GXG9G
    Cetyl dimethylbutyl ether is a synthetic liquid used in medicines as an emollient and solvent. It helps dissolve active ingredients and improves how the medicine spreads or absorbs when applied to skin or taken orally.
  • 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.
  • 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII R6G12EY23X
    A synthetic liquid derived from coconut oil components combined with glycol. It acts as a solvent and emulsifier to help dissolve active ingredients and keep oil and water components mixed in the formulation.
  • 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 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 151Z7P1317
    Hexyldecanol is a waxy alcohol derived from natural oils. It acts as an emollient and viscosity agent in topical formulations, helping create smooth texture and improve product spreadability on skin.
  • UNII 0V595C1P6M
    A synthetic oil made from fatty acids and alcohols. It acts as an emollient and lubricant in topical products, helping them spread smoothly on skin and improving texture.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 184IZ28A2G
    A silicone-based conditioning agent made by combining polyethylene glycol, polypropylene glycol, and dimethicone. It functions as an emulsifier and skin-conditioning ingredient to help blend oil and water components and improve product texture and spreadability.
  • UNII 46P231IQV8
    A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
  • 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII SAS9Z1SVUK
    A natural oil extracted from ginger root that adds flavor and aroma to the medicine. It may also serve as a preservative or help mask unpleasant tastes in the formulation.

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

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
Mineral Based Sunscreen Stick Tinted 55 mg/g; 40 mg/g 81679-0220-30 KATHLEEN 30 g — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85413-0212-45 HALEM 1 cylinder — — FDA listed —
Flash Invisible Stick 55 mg/g; 40 mg/g 85497-0219-30 AEON 30 g — — FDA listed —
Sun Plus Sun Lip Shield 55 mg/g; 40 mg/g 85599-0212-45 CLEAN 1 cylinder — — FDA listed —
Mineral Lip Sunscreen Tinted 55 mg/g; 40 mg/g 85634-0212-45 DR. 1 cylinder — — FDA listed —
Sheer Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85317-0212-45 TRU 4.5 g — — FDA listed —
Advanced Lip Guard 55 mg/g; 40 mg/g 85351-0212-45 ADVANCED 4.5 g — — FDA listed —
Sunshade Mineral Stick Sunscreen 55 mg/g; 40 mg/g 85730-0219-30 BELLAGENA 30 g — — FDA listed —
CoTZ Kids Mineral Sun Stick 55 mg/g; 40 mg/g 58892-0362-30 Fallien 1 cylinder — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85581-0212-45 Helen's 1 cylinder — — FDA listed —
Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85327-0212-45 Rhonda 1 cylinder — — FDA listed —
Lip Balm 55 mg/g; 40 mg/g 85649-0212-45 PATRICIA 1 cylinder — — FDA listed —
Lip Crack 55 mg/g; 40 mg/g 85730-0212-45 BELLAGENA 1 cylinder — — FDA listed —
Kind Restore Moisturizing Lip Balm 55 mg/g; 40 mg/g 85895-0212-45 POLISH 1 cylinder — — FDA listed —
Really Great Lip Shield 55 mg/g; 40 mg/gthis 85585-0212-45 JEFFREY 1 cylinder — — FDA listed —
Mineral Lip Protection 55 mg/g; 40 mg/g 85504-0212-45 COLETTE 1 cylinder — — FDA listed —
Mineral Stick Tinted 55 mg/g; 40 mg/g 85507-0220-30 IT 30 g — — FDA listed —
Mineral Lip Protection 55 mg/g; 40 mg/g 85563-0212-45 CLEAR 4.5 g — — FDA listed —
Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85608-0212-45 LA 1 cylinder — — FDA listed —
Lip Protection 55 mg/g; 40 mg/g 85339-0212-45 Teton 1 cylinder — — FDA listed —
Mineral Stick Non-Tinted 55 mg/g; 40 mg/g 85507-0219-30 IT 30 g — — FDA listed —
Lip Protecting 55 mg/g; 40 mg/g 85531-0212-45 JOHANNA'S 4.5 g — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85558-0212-45 LOTUS 1 cylinder — — FDA listed —
Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85596-0212-45 LAURA 1 cylinder — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85625-0212-45 LUNDQUIST 1 cylinder — — FDA listed —
Non-Tinted Sports Stick 55 mg/g; 40 mg/g 85679-0219-30 HELTON 30 g — — FDA listed —
Tinted Lip Shade Sunscreen 55 mg/g; 40 mg/g 85712-0212-45 BLISS 1 cylinder — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85888-0212-45 MILESTHETICS 1 cylinder — — FDA listed —
Mineral Sunscreen Stick Non-Tinted 55 mg/g; 40 mg/g 87572-0219-30 UNDRBUDR, 30 g — — FDA listed —
Non Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85374-0219-30 BABYFACE 30 g — — FDA listed —
Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85414-0220-30 Hirschman, 30 g — — FDA listed —
Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85492-0212-14 The 1 cylinder — — FDA listed —
Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85598-0220-30 BASS 30 g — — FDA listed —
Mineral Tinted Lip Sunscreen 55 mg/g; 40 mg/g 85620-0212-45 JADEIA 4.5 g — — FDA listed —
Non Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85888-0219-30 MILESTHETICS 30 g — — FDA listed —
Mineral Sunscreen Stick - Tinted 55 mg/g; 40 mg/g 87572-0220-30 UNDRBUDR, 30 g — — FDA listed —
Mineral Based Sunscreen Stick Non-Tinted 55 mg/g; 40 mg/g 81679-0219-30 KATHLEEN 30 g — — FDA listed —
Sunscreen Plus Mineral Stick Tinted 55 mg/g; 40 mg/g 85329-0220-30 Lily 30 g — — FDA listed —
Sun Safe Lip Balm 55 mg/g; 40 mg/g 85628-0212-45 REVIVE 1 cylinder — — FDA listed —
Tinted Lip Protection 55 mg/g; 40 mg/g 85747-0212-45 WECARE 1 cylinder — — FDA listed —
Tinted Mineral Sunscreen Stick 55 mg/g; 40 mg/g 85888-0220-30 MILESTHETICS 30 g — — FDA listed —
Tinted Mineral Lip Sunscreen 55 mg/g; 40 mg/g 85939-0212-45 ORAIOS 1 cylinder — — FDA listed —
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen 55 mg/g; 40 mg/g 58892-0212-45 Fallien 4.5 g — — 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

🏛️
2022
On the market since
May 2022
📍
2026
Currently FDA-listed
4 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
85585-0212-45 You're viewing this 1 CYLINDER in 1 CARTON (85585-212-45) / 4.5 g in 1 CYLINDER 2022-05-26 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 85585-212-45, 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: 85585-0212-45, written without dashes as 85585021245. 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 85585-0212-45, the first segment (85585) is the labeler code FDA assigned to JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION; the middle segment (0212) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) 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 JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION 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.
📄 FDA label
📄 FDA label 9 words ▾

No readable label sections were found for this product.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85585-0205-15 · JEFFREY 85586-0001-02 · LAP →
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.