Over-the-counter drug · OTC MONOGRAPH DRUG
Hawaiian Tropic (Avobenzone,homosalate,octocrylene) NDC 63354-621
Homosalate 7 g/100g + 2 more ingredients · Lotion · Topical · Edgewell Personal Care Brands LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63354-621Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63354-0621Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63354-621-24 | 6335406212463354062124 | 177 g in 1 TUBE (63354-621-24)Marketed from Jan 5, 2022 |
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)
- Hawaiian Tropic
- Generic name (nonproprietary)
- avobenzone,homosalate,octocrylene
- Active ingredients
- Homosalate — 7 g/100gOctocrylene — 4.2 g/100gAvobenzone — 2.2 g/100g
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Edgewell Personal Care Brands LLCNDC labeler code 63354
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 020
- Marketing start
- Marketing end
- Identifiers
- Product ID 63354-621_25822859-7a14-6dfc-e063-6394a90ab740SPL ID 25822859-7a14-6dfc-e063-6394a90ab740SPL set ID 16b3c10c-d98b-c424-e063-6394a90a7734UNII V06SV4M95S, 5A68WGF6WM, G63QQF2NOX
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
N463354062124followed by a unit qualifier and the quantityPackage 63354-0621-24. 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 63354-621
- What is NDC 63354-621?
- 63354-621 is the product NDC for Hawaiian Tropic, Homosalate 7 g/100g + 2 more ingredients lotion, listed with the FDA by Edgewell Personal Care Brands LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hawaiian Tropic (Avobenzone,Homosalate,Octocrylene).
- What is the active ingredient?
- Homosalate, Octocrylene, Avobenzone.
- Who is the labeler?
- Edgewell Personal Care Brands LLC, NDC labeler code 63354. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hawaiian Tropic?
- 35 other product NDCs are listed under this name. See all Hawaiian Tropic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hawaiian Tropic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hawaiian Tropicavobenzone, homosalate, octocrylene | Octocrylene 6 g/100g + 2 more ingredients | SprayTopical | Edgewell Personal Care Brands LLC | 63354-072 | 63354-0072-12 |
| Hawaiian Tropicavobenzone,homosalate,octisalate,octocrylene | Homosalate 9 g/100g + 3 more ingredients | StickTopical | Edgewell Personal Care Brands LLC | 63354-791 | 63354-0791-61 |
| Hawaiian Tropicavobenzone,homosalate,octisalate,octocrylene | Octocrylene 4.5 g/100g + 3 more ingredients | LotionTopical | Edgewell Personal Care Brands, LLC | 63354-062 | 63354-0062-54 |
| Hawaiian Tropicavobenzone,homosalate,octisalate,octocrylene | Octisalate 4.5 g/100g + 3 more ingredients | LotionTopical | Edgewell Personal Care Brands, LLC | 63354-355 | 63354-0355-54 |
| Hawaiian Tropichomosalate,octocrylene,octisalate,avobenzone | Octisalate 4.5 g/100g + 3 more ingredients | StickTopical | Edgewell Personal Care Brands LLC | 63354-861 | 63354-0861-61 |
| Hawaiian Tropicavobenzone/octocrylene | Avobenzone .2 g/100g; Octocrylene .5 g/100g | LotionSuprachoroidal | Edgewell Personal Care Brands LLC | 63354-972 | 63354-0972-56 |
| Hawaiian Tropicavobenzone,octisalate,octocrylene | Octisalate 4.5 g/100g + 2 more ingredients | OilTopical | Edgewell Personal Care Brands LLC | 63354-784 | 63354-0784-16 |
| Hawaiian Tropicavobenzone,homosalate,octisalate,octocrylene | Avobenzone 1.5 g/100g + 3 more ingredients | Aerosol, SprayTopical | Edgewell Personal Care Brands LLC | 63354-302 | 63354-0302-34 |
| Hawaiian Tropicavobenzone,homosalate,octisalate,octocrylene | Octocrylene 6.5 g/100g + 3 more ingredients | LotionTopical | Edgewell Personal Care Brands LLC | 63354-611 | 63354-0611-22 |
| Hawaiian Tropicavobenzone,homosalate,octisalate,octocrylene | Octocrylene 9 g/100g + 3 more ingredients | GelTopical | Edgewell Personal Care Brands LLC | 63354-701 | 63354-0701-21 |
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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