Over-the-counter drug · OTC MONOGRAPH DRUG
Powder (Titanium dioxide) NDC 61354-189
Titanium dioxide 10 mg/100mg · Powder · Topical · Oxygen Development LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)61354-189Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61354-0189Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61354-189-01 | 6135401890161354018901 | 1 CUP in 1 CARTON (61354-189-01) / 100 mg in 1 CUPMarketed from Jul 25, 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
- Titanium 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 61354-189_4d39fb2d-8fa3-07c9-e063-6394a90a0d4eSPL ID 4d39fb2d-8fa3-07c9-e063-6394a90a0d4eSPL set ID 4d39ed7a-ca80-893c-e063-6294a90a03e7UNII 15FIX9V2JPUPC 0847137046743
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
N461354018901followed by a unit qualifier and the quantityPackage 61354-0189-01. 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 61354-189
- What is NDC 61354-189?
- 61354-189 is the product NDC for Powder (titanium dioxide), 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?
- 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 | Ferric oxide red 1.75 mg/100mg; Titanium dioxide 10 mg/100mg | PowderTopical | Oxygen Development LLC | 61354-190 | 61354-0190-01 |
| 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 |
|---|---|---|---|---|
| Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 Sunscreenavobenzone, octisalate, octocrylene | Avobenzone 30 mg/mL + 2 more ingredients | LotionTopical | WALGREEN COMPANY | 0363-0172 |
| Walgreens 100 Sheer Broad Spectrum SPF 100avobenzone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/mL + 3 more ingredients | LotionTopical | WALGREEN COMPANY | 0363-0228 |
| Radiance Foundation Broad Spectrum SPF 20 - Cappuccinooctinoxate, zinc oxide | Octinoxate 3 g/100mL; Zinc oxide 6.8 g/100mL | LiquidTopical | Distribuidora Comercial Jafra, S.A. de C.V. | 68828-735 |
| Sun Bum High Performance Sunscreen Signature Clear 50 Newoctocrylene, octisalate, zinc oxide | Octisalate 50 mg/mL + 2 more ingredients | LotionTopical | Sun Bum, LLC | 69039-708 |
| Scentual Aroma Beauty Sun Veil SPF30titanium dioxide, zinc oxide | Titanium dioxide 2 g/100g; Zinc oxide 18.4 g/100g | CreamTopical | LABORATOIRES DRUIDE INC | 71447-056 |
| Crunchi Sunlight Tinted Sunscreen SPF 30 Mediumzinc oxide | Zinc oxide 940 mg/mL | LiquidTopical | Crunchi, LLC. | 72444-0204 |
| Farmasi BB Beauty Balm Cream SPF 15- 01 Lighttitanium dioxide | Titanium dioxide 35 mg/mL | CreamTopical | Farmasi US LLC | 74690-040 |
| Hydrating Glow Mist SPF 50avobenzone, octisalate, octocrylene | Avobenzone 3 g/100mL + 3 more ingredients | SprayTopical | NAKED SUNDAYS PTY LTD | 81104-102 |
| COOLA SunBlur Makeup Mist SPF 50avobenzone, homosalate, octisalate, octocrylene | Octocrylene 80 mg/mL + 3 more ingredients | SprayTopical | COOLA LLC | 79753-107 |
| spf 50 mineral powder sunscreentitanium dioxide, zinc oxide | Titanium dioxide 23.9 g/100g; Zinc oxide 24.1 g/100g | PowderTopical | Smalls Brand LLC DBA Roe Wellness | 83369-001 |
| Odacite Nourishing Lip Serum - Jazzy Berryzinc oxide | Zinc oxide 132 mg/mL | LotionTopical | Odacite | 82088-876 |
| Visor Clear Body Oil-Free Sunscreen SPF 50avobenzone, homosalate, octisalate, octocrylene | Avobenzone 30 mg/mL + 3 more ingredients | GelTopical | VISOR SKINCARE LLC | 85335-589 |
| Non Tinted Mineral Sunscreen Sticktitanium dioxide, zinc oxide | Titanium dioxide 40 mg/g; Zinc oxide 55 mg/g | StickTopical | Hirschman, Kristina | 85414-219 |
| Headhunter Surf Screen SPF 50 Sunscreenzinc oxide,titanium dioxide | Titanium dioxide 5.6 mg/100mL; Zinc oxide 11 mg/100mL | CreamTopical | Guangzhou Tata Biotechnology Co., Ltd. | 84066-107 |
| Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 Sensitiveavobenzone, homosalate, octisalate, and octocrylene | Avobenzone 3 g/100mL + 3 more ingredients | LotionTopical | The Procter & Gamble Manufacturing Company | 84126-232 |
| Orlaskin Hydrating Sunscreen SPF 50octocrylene ethylhexyl methoxycinnamate ethylhexyl salicylate avobenzone | Octocrylene 10 g/100mL + 3 more ingredients | SprayTopical | Guangzhou Yapheon Health Industry Co., Ltd. | 87582-004 |
| Luxe Gloss Hydrating Lip Gloss SPF 35-ICED OUToctocrylene 8%, octisalate 5%, titanium dioxide 6%, zinc oxide 8% | Octocrylene .08 g/mL + 3 more ingredients | CreamTopical | Lale Cosmetics LLC | 87911-003 |
| UV Defense Mineral Sunscreen Tintedtitanium dioxide, zinc oxide | Zinc oxide 38 mg/g; Titanium dioxide 80 mg/g | CreamTopical | CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC | 85495-203 |
| Reunited Lipgloss SPF 30 - WALKING ON SUNSHINEhomosalate, octocrylene, octisalate | Homosalate 8 g/100mL + 2 more ingredients | LiquidTopical | Princeville Productions, LLC, DBA Reunited Beauty | 87326-002 |
| Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUShomosalate,octisalate,octocrylene,zinc oxide | Octocrylene 6 g/100g + 3 more ingredients | LotionTopical | Edgewell Personal Care Brands LLC | 63354-682 |
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