Over-the-counter drug · OTC MONOGRAPH DRUG
Non Tinted Mineral Sunscreen (Zinc oxide) NDC 85395-205
Zinc oxide 200 mg/g · Cream · Topical · SPECKTRA6 LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)85395-205Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85395-0205Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85395-205-04 | 8539502050485395020504 | 113 g in 1 BOTTLE, PUMP (85395-205-04)Marketed from Apr 19, 2021 |
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)
- Non Tinted Mineral Sunscreen
- Generic name (nonproprietary)
- zinc oxide
- Active ingredients
- Zinc oxide — 200 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- SPECKTRA6 LLCNDC labeler code 85395
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 85395-205_45b0e810-9832-c30c-e063-6294a90a6019SPL ID 45b0e810-9832-c30c-e063-6294a90a6019SPL set ID 374f063a-1ea6-2fcc-e063-6394a90ac574UNII SOI2LOH54Z
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
N485395020504followed by a unit qualifier and the quantityPackage 85395-0205-04. 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 85395-205
- What is NDC 85395-205?
- 85395-205 is the product NDC for Non Tinted Mineral Sunscreen (zinc oxide), Zinc oxide 200 mg/g cream, listed with the FDA by SPECKTRA6 LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Non Tinted Mineral Sunscreen (Zinc Oxide).
- What is the active ingredient?
- Zinc oxide.
- Who is the labeler?
- SPECKTRA6 LLC, NDC labeler code 85395. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Non Tinted Mineral Sunscreen?
- 17 other product NDCs are listed under this name. See all Non Tinted Mineral Sunscreen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Non Tinted Mineral 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) |
|---|---|---|---|---|---|
| Non Tinted Mineral Sunscreentitanium dioxide, zinc oxide | Zinc oxide 38 mg/g; Titanium dioxide 80 mg/g | CreamTopical | MILESTHETICS LLC | 85888-202 | 85888-0202-50 |
| Non-Tinted Mineral Sunscreenzinc oxide | Zinc oxide 200 mg/g | CreamTopical | OLGA KLIMOV INC | 85805-205 | 85805-0205-04 |
| Non Tinted Mineral Sunscreenzinc oxide | Zinc oxide 200 mg/g | CreamTopical | Natur LLC | 85589-205 | 85589-0205-04 |
| Non - Tinted Mineral Sunscreenzinc oxide | Zinc oxide 200 mg/g | CreamTopical | NEXTEX CORPORATION | 85575-205 | 85575-0205-04 |
| Non-Tinted Mineral Sunscreentitanium dioxide, zinc oxide | Zinc oxide 38 mg/g; Titanium dioxide 80 mg/g | CreamTopical | HSC MIAMI, INC | 85376-202 | 85376-0202-50 |
| non-tinted mineral sunscreentitanium dioxide, zinc oxide | Zinc oxide 38 mg/g; Titanium dioxide 80 mg/g | CreamTopical | Clove Hill LLC | 82746-202 | 82746-0202-50 |
| Non-Tinted Mineral Sunscreenzinc oxide | Zinc oxide 160 mg/g | CreamTopical | WECARE FRISCO PLLC | 85747-226 | 85747-0226-15 |
| Non Tinted Mineral Sunscreentitanium dioxide, zinc oxide | Zinc oxide 38 mg/g; Titanium dioxide 80 mg/g | CreamTopical | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 85585-202 | 85585-0202-15 |
| Non-Tinted Mineral Sunscreentitanium dioxide, zinc oxide | Titanium dioxide 80 mg/g; Zinc oxide 38 mg/g | CreamTopical | Face 5, LLC | 85302-202 | 85302-0202-50 |
| Non Tinted Mineral Sunscreenzinc oxide | Zinc oxide 200 mg/g | CreamTopical | Micro Fibro Blast | 85460-205 | 85460-0205-04 |
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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