Over-the-counter drug · OTC MONOGRAPH DRUG
Mineral Lip Sunscreen (Titanium dioxide, zinc oxide) NDC 85413-212
Zinc oxide 55 mg/g; Titanium dioxide 40 mg/g · Stick · Topical · HALEM DERMATOLOGY PLLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)85413-212Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85413-0212Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85413-212-45 | 8541302124585413021245 | 1 CYLINDER in 1 CYLINDER (85413-212-45) / 4.5 g in 1 CYLINDERMarketed from Jan 11, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mineral Lip Sunscreen
- Generic name (nonproprietary)
- titanium dioxide, zinc oxide
- Active ingredients
- Zinc oxide — 55 mg/gTitanium dioxide — 40 mg/g
- Dosage form
- Stick
- Route
- Topical
- Labeler
- HALEM DERMATOLOGY PLLCNDC labeler code 85413
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 85413-212_45b3b0ef-0939-2a47-e063-6294a90aea60SPL ID 45b3b0ef-0939-2a47-e063-6294a90aea60SPL set ID 35bce44e-d9f4-9279-e063-6394a90a6453UNII SOI2LOH54Z, 15FIX9V2JP
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485413021245followed by a unit qualifier and the quantityPackage 85413-0212-45. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
About NDC 85413-212
- What is NDC 85413-212?
- 85413-212 is the product NDC for Mineral Lip Sunscreen, Zinc oxide 55 mg/g; Titanium dioxide 40 mg/g stick, listed with the FDA by HALEM DERMATOLOGY PLLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mineral Lip Sunscreen (Titanium Dioxide, Zinc Oxide).
- What is the active ingredient?
- Zinc oxide, Titanium dioxide.
- Who is the labeler?
- HALEM DERMATOLOGY PLLC, NDC labeler code 85413. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mineral Lip Sunscreen?
- 14 other product NDCs are listed under this name. See all Mineral Lip Sunscreen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mineral Lip Sunscreen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 55 mg/g | StickTopical | UNDRBUDR, LLC | 87572-212 | 87572-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 55 mg/g | StickTopical | Healthy Skin & Body LLC | 85726-212 | 85726-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Zinc oxide 55 mg/g; Titanium dioxide 40 mg/g | StickTopical | LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER | 85625-212 | 85625-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 55 mg/g | StickTopical | ASHLEY SAMAI | 85862-212 | 85862-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 38 mg/g | StickTopical | CAPE COD SKIN CARE CO. INC. | 85627-212 | 85627-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Zinc oxide 55 mg/g; Titanium dioxide 40 mg/g | StickTopical | MILESTHETICS LLC | 85888-212 | 85888-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 55 mg/g | StickTopical | ADVANCED AESTHETICS SKIN CARE STUDIO, INC | 85325-212 | 85325-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Zinc oxide 55 mg/g; Titanium dioxide 40 mg/g | StickTopical | The Essential Brazilian Spa LLC | 85492-212 | 85492-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 55 mg/g | StickTopical | Mantra Wellness Spa | 85377-212 | 85377-0212-45 |
| Mineral Lip Sunscreentitanium dioxide, zinc oxide | Zinc oxide 55 mg/g; Titanium dioxide 40 mg/g | StickTopical | LOTUS SKINCARE AND MAKE-UP STUDIO | 85558-212 | 85558-0212-45 |
Other NDCs under M 020
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08titanium dioxide and zinc oxide | Titanium dioxide 1440 mg/8g; Zinc oxide 1760 mg/8g | PowderTopical | Orveon Global US LLC | 98132-010 |
| BelleJoss BROAD SPECTRUM SPF 50broad spectrum spf 50 | Ethylhexyl methoxycinnamate 7.4925 mg/100mg | CreamTopical | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 87770-002 |
| Mineral Based Foam Sunscreen Non-Tintedtitanium dioxide, zinc oxide | Titanium dioxide 30 mg/g; Zinc oxide 100 mg/g | Aerosol, FoamTopical | KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | 81679-211 |
| COOLA Classic Body SPF 50 Guava Mangoavobenzone, homosalate, octisalate, octocrylene | Avobenzone 2.9 g/100mL + 3 more ingredients | SprayTopical | COOLA, LLC | 79753-059 |
| Golden Rose Glow Kiss Tinted Lip Balm Vanilla Latteavobenzone, octinoxate | Avobenzone 2.7 g/100g; Octinoxate 6 g/100g | LipstickTopical | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 82715-109 |
| Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tintedzinc oxide | Zinc oxide 160 mg/g | CreamTopical | NY BEAUTY PALACE LLC | 85404-208 |
| Tinted Mineral Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 80 mg/g; Zinc oxide 38 mg/g | CreamTopical | The Essential Brazilian Spa LLC | 85492-203 |
| Tinted Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 80 mg/g; Zinc oxide 38 mg/g | CreamTopical | Scottsdale Skin Boutique and Dermatology Pllc | 85331-203 |
| First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30zinc oxide | Zinc oxide 22 g/100mL | LiquidTopical | The Procter & Gamble Manufacturing Company | 84126-214 |
| the beach people SPF 15zinc oxide | Zinc oxide 12 g/100mL | LotionTopical | The Beach People United LLC | 84530-100 |
| Tinted Sunscreen Broad SPF30 | Zinc oxide 7.5 g/100g; Titanium dioxide 3.2 g/100g | CreamTopical | DOSCHER FAMILY HEALTH NP P.C. | 84608-0651 |
| Flawless Future SPF 30octinoxate, octisalate, oxybenzone, avaobenzone | Octinoxate 7.14 mg/g + 3 more ingredients | EmulsionTopical | REVLON | 10967-683 |
| Lbel Forever Matte Base Control Brillo Y Larga Duracion 48H Fps 15 Control And Longwear Foundation 48H SPF 15 Latte 180-Foctinoxate, zinc oxide | Octinoxate 50 mg/g; Zinc oxide 49 mg/g | EmulsionTopical | BEL STAR S.A. | 14141-342 |
| Pro-Tect Sports Sunscreenmeradimate, octinoxate, octisalate, oxybenzone | Octinoxate 75 mg/g + 3 more ingredients | LotionCutaneous | Bio-Medical & Pharmaceutical Manufacturing Corporation | 37945-862 |
| ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30titanium dioxide and zinc oxide | Titanium dioxide 10 mg/mL; Zinc oxide 200 mg/mL | CreamTopical | ZO Skin Health, Inc. | 42851-060 |
| Artistry Exact Fit Longwearing Foundation Shade Golden L4N1titanium dioxide | Titanium dioxide 40.25 mg/mL | CreamTopical | Amway Corp | 50390-205 |
| Derma B Everyday Fit Sunscreen SPF 50avobezone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/mL + 3 more ingredients | LotionTopical | NeoPharm Co., Ltd. | 51141-0701 |
| Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50homosalate, octisalate, octocrylene, zinc oxide | Homosalate 6 g/50mL + 3 more ingredients | CreamTopical | CMS LAB Inc. | 52554-9062 |
| SPF 30 Sunscreenavobenzone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/g + 3 more ingredients | Aerosol, SprayTopical | DEMOULAS SUPER MARKETS, INC | 53942-002 |
| Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivorytitanium dioxide and zinc oxide | Titanium dioxide 50 mg/mL; Zinc oxide 50 mg/mL | CreamTopical | PML NYC, LLC | 59735-900 |
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