Over-the-counter drug · OTC MONOGRAPH DRUG
Powder (Titanium dioxide) NDC 61354-190
Ferric oxide red 1.75 mg/100mg; Titanium dioxide 10 mg/100mg · Powder · Topical · Oxygen Development LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)61354-190Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61354-0190Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61354-190-01 | 61354019001 | 1 CUP in 1 CARTON (61354-190-01) / 100 mg in 1 CUPMarketed from Jul 18, 2025 |
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)
- Powder
- Generic name (nonproprietary)
- titanium dioxide
- Active ingredients
- Ferric oxide red — 1.75 mg/100mgTitanium dioxide — 10 mg/100mg
- Dosage form
- Powder
- Route
- Topical
- Labeler
- Oxygen Development LLCNDC labeler code 61354
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 61354-190_4d3a0eae-1e8c-3460-e063-6394a90a8c81SPL ID 4d3a0eae-1e8c-3460-e063-6394a90a8c81SPL set ID 4d3a0a92-b0de-a1ea-e063-6294a90a8508UNII 1K09F3G675, 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
N461354019001followed by a unit qualifier and the quantityPackage 61354-0190-01. 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 .
Indications (excerpt from the label)
Uses Helps prevent sunburn.
Excerpt only. Read the full label for complete information.
About NDC 61354-190
- What is NDC 61354-190?
- 61354-190 is the product NDC for Powder (titanium dioxide), Ferric oxide red 1.75 mg/100mg; Titanium dioxide 10 mg/100mg powder, listed with the FDA by Oxygen Development LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Powder (Titanium Dioxide).
- What is the active ingredient?
- Ferric oxide red, Titanium dioxide.
- Who is the labeler?
- Oxygen Development LLC, NDC labeler code 61354. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Powder?
- 5 other product NDCs are listed under this name. See all Powder NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Powder products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Powdertitanium dioxide | Titanium dioxide 10 mg/100mg | PowderTopical | Oxygen Development LLC | 61354-189 | 61354-0189-01 |
| Powdertitanium dioxide | Ferric oxide red 1.75 mg/100mg; Titanium dioxide 10 mg/100mg | PowderTopical | Oxygen Development LLC | 61354-117 | 61354-0117-02 |
| Powdertitanium dioxide | Ferric oxide red 1.75 mg/100mg; Titanium dioxide 10 mg/100mg | PowderTopical | Oxygen Development LLC | 61354-118 | 61354-0118-02 |
| Powdertitanium dioxide | Ferric oxide red 1.75 mg/100mg; Titanium dioxide 10 mg/100mg | PowderTopical | Oxygen Development LLC | 61354-119 | 61354-0119-02 |
| Powdertitanium dioxide | Titanium dioxide 10 mg/100mg | PowderTopical | Oxygen Development LLC | 61354-188 | 61354-0188-01 |
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 |
|---|---|---|---|---|
| Soft Focus Mineral Defense Tintedtitanium dioxide, zinc oxide | Titanium dioxide 80 mg/g; Zinc oxide 38 mg/g | CreamTopical | SPOTLESS SKIN STUDIO | 85607-203 |
| SPF 15 Spearmint Lip Balmzinc oxide | Zinc oxide 35 mg/g | StickTopical | Naples Soap Company, Inc. | 84489-269 |
| SUNSCREEN SPRAY150mLzinc oxide 12%, titanium dioxide 6%, homosalate 14%, octisalate 5% | Homosalate .14 g/mL + 3 more ingredients | LiquidTopical | Foshan Sugar Max Cosmetics CO.,Ltd | 84938-014 |
| Sheglam Dew and Done Skin Tint with SPF 20 Dark Clovezinc oxide | Zinc oxide 146.25 mg/mL | CreamTopical | EVER FAME PTE. LTD. | 85068-012 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 22Whomosalate, zinc oxide | Homosalate 65 mg/mL; Zinc oxide 57 mg/mL | LotionTopical | Rare Beauty, LLC | 82109-129 |
| Omic Mineral Sunscreenzinc oxide | Zinc oxide .18 g/g | LotionTopical | Mitchell Cosmetics, Inc | 79009-902 |
| PRIDEFUL SPF 15 LIP BALM-citrushomosalate, octisalate, octocrylene, avobenzone | Homosalate 100 mg/g + 3 more ingredients | StickTopical | PRIDEFUL LLC | 82866-001 |
| Tirtir Hydro UV Shield Sunscreen SPF50 Broad Spectrumhomosalate, avobenzone, octisalate, octocrylene | Homosalate 90 mg/mL + 3 more ingredients | LotionTopical | TIRTIR USA Inc. | 87496-201 |
| Poth Clear Gel Sunscreen SPF 50avobenzone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/mL + 3 more ingredients | GelTopical | Poth LLC | 87669-963 |
| HealthyDerm tallow mineral sunscreen SPF50zinc oxide 25% | Zinc oxide .25 g/g | CreamTopical | VIRENTIA LLC | 87805-001 |
| Sun Defense Minerals (Medium)zinc oxide, titanium dioxide | Zinc oxide 235 mg/g; Titanium dioxide 165 mg/g | PowderTopical | Eminence Organic Skin Care | 15751-3603 |
| MISSHA M Perfect Cover BB No.45octinoxate, zinc oxide, titanium dioxide | Zinc oxide 7 g/100mL + 2 more ingredients | CreamTopical | Able C&C Co., Ltd. | 13733-258 |
| Lbel Solutions Pro Nude Skin Base Serum Tint Cobertura Antimanchas Fps 15 Anti Dark Spot Coverage Serum Tint Foundation SPF 15 Latte 180-Foctinoxate, zinc oxide | Zinc oxide 29.4 mg/mL; Octinoxate 60 mg/mL | EmulsionTopical | BEL STAR S.A. | 14141-588 |
| Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUShomosalate, octisalate, titanium dioxide, zinc oxide | Homosalate 4.5 g/60mL + 3 more ingredients | CreamTopical | ATOMY CO., LTD. | 52257-1460 |
| belif Aqua bomb - glow sunstick SPF50avobenzone, homosalate, octisalate, octocrylene | Avobenzone 2.7 g/100g + 3 more ingredients | StickTopical | LG H&H CO., LTD. | 53208-731 |
| cle de peau BEAUTE THE FOUNDATION N O40 LIGHT TAN OCHERoctinoxate and titanium dioxide | Octinoxate 1092 mg/28mL; Titanium dioxide 924 mg/28mL | EmulsionTopical | SHISEIDO AMERICAS CORPORATION | 58411-844 |
| Tula Radiant Skin Brightening Serum Skin Tint Sunscreen Broad Spectrum SPF 30brightening skin tint | Octisalate 5 g/30mL; Avobenzone 3 g/30mL | LotionTopical | PML NYC, LLC | 59735-214 |
| Youth 2 Activating BB Cream SPF 30 Light Mediumzinc oxide, titanium dioxide | Zinc oxide 63 mg/mL; Titanium dioxide 23.6 mg/mL | LotionTopical | Shaklee Corporation | 59899-011 |
| Thinkkids SPF 50zinc oxide | Zinc oxide 234 mg/mL | LotionTopical | thinkOperations,LLC | 60781-4279 |
| FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3CRoctisalate, titanium dioxide | Octisalate 45 mg/mL; Titanium dioxide 42.3 mg/mL | EmulsionTopical | Parfums Christian Dior | 61957-3123 |
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