Over-the-counter drug · OTC MONOGRAPH DRUG
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n NDC 58411-454
avobenzone, octinoxate, octocrylene, and oxybenzone · Avobenzone 3200 mg/125mL + 3 more ingredients · Emulsion · Topical · SHISEIDO AMERICAS CORPORATION
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58411-454Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58411-0454Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58411-454-10 | 5841104541058411045410 | 1 CONTAINER in 1 CARTON (58411-454-10) / 125 mL in 1 CONTAINERMarketed from Feb 1, 2019 |
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)
- CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n
- Generic name (nonproprietary)
- avobenzone, octinoxate, octocrylene, and oxybenzone
- Active ingredients
- Avobenzone — 3200 mg/125mLOctinoxate — 9472 mg/125mLOctocrylene — 2560 mg/125mLOxybenzone — 1280 mg/125mL
- Dosage form
- Emulsion
- Route
- Topical
- Labeler
- SHISEIDO AMERICAS CORPORATIONNDC labeler code 58411
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Listing expires
- Identifiers
- Product ID 58411-454_47aa45d8-6669-112b-e063-6294a90a76fbSPL ID 47aa45d8-6669-112b-e063-6294a90a76fbSPL set ID 207e2035-5f31-4745-a801-b386b040b738UNII G63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM, 95OOS7VE0Y
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
N458411045410followed by a unit qualifier and the quantityPackage 58411-0454-10. 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 if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Excerpt only. Read the full label for complete information.
About NDC 58411-454
- What is NDC 58411-454?
- 58411-454 is the product NDC for CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n, Avobenzone 3200 mg/125mL + 3 more ingredients emulsion, listed with the FDA by SHISEIDO AMERICAS CORPORATION. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n (Avobenzone, octinoxate, octocrylene, and oxybenzone).
- What is the active ingredient?
- Avobenzone, Octinoxate, Octocrylene, Oxybenzone.
- Who is the labeler?
- SHISEIDO AMERICAS CORPORATION, NDC labeler code 58411. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n?
- 2 other product NDCs are listed under this name. See all CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| cle de peau BEAUTE PROTECTIVE FORTIFYING navobenzone, octinoxate, octocrylene, and oxybenzone | Avobenzone 1.031 g/50mL + 3 more ingredients | CreamTopical | SHISEIDO AMERICAS CORPORATION | 58411-857 | 58411-0857-40 |
| CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING navobenzone, octinoxate, octocrylene, and oxybenzone | Avobenzone .2472 g/12mL + 3 more ingredients | EmulsionTopical | SHISEIDO AMERICAS CORPORATION | 58411-562 | 58411-0562-10 |
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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