HAWAIIAN TROPIC
- Product NDC
- 63354-319
- 11-digit product format
- 633540319
- Labeler code
- 63354
- Product ID
- 63354-319_41b01e12-6a50-b34c-e063-6394a90a98e3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AVOBENZONE OCTISALATE OCTOCRYLENE
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Edgewell Personal Care Brands LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-11-30
- Marketing end
- 2027-09-11
- Substance
- OCTISALATE; AVOBENZONE; OCTOCRYLENE
- Active strength
- 2.5; 2; 3 g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HAWAIIAN TROPIC
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTISALATE | 2.5 g/100g |
| AVOBENZONE | 2 g/100g |
| OCTOCRYLENE | 3 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4X49Y0596W | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0b625d48-9632-0464-e063-6394a90a9adc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63354-319-16 | HAWAIIAN TROPIC | 236 g in 1 BOTTLE, PUMP | OIL | 236 | 2 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mine Line Coconut Sunscreen SPF 50 | ZINC OXIDE | Spa de Soleil | 4642b1cc-43b1-6997-e063-6394a90ac764 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 30 Broad Spectrum Sunscreen | SPF 30 BROAD SPECTRUM SUNSCREEN | SnugZ/USA, LLC | 69ac1218-76e6-04ff-e053-2a91aa0a4080 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Sunscreen Spry | SPF 50 SUNSCREEN SPRAY | SnugZ USA | 9390ea21-9f9f-14e2-e053-2a95a90ac577 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 15 Flavored Beeswax Lip Balm | SPF 15 FLAVORED BEESWAX LIP BALM | SnugZ/USA, LLC | 69bdfaaf-d49e-bf31-e053-2a91aa0affd3 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Broad Spectrum Sunscreen | SPF 50 BROAD SPECTRUM SUNSCREEN | SnugZ/USA, LLC | b7a3eed5-c8ca-ffda-e053-2a95a90a73bb | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 15 Beeswax Lip Balm | SPF 15 BEESWAX LIP BALM | SnugZ/USA, LLC | 68816d3a-dbe9-7ce3-e053-2a91aa0a395e | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 30 Soy Lip Balm | SPF 30 SOY LIP BALM | SnugZ/USA, LLC | 687ff49d-2d0e-2534-e053-2991aa0a2864 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Sunscreen Stick | SPF 50 SUNSTICK | SnugZ/USA, LLC | 6e1179cf-5bfb-1156-e053-2991aa0a5b46 | 2025-12-29 | Warnings | M020 |
| OUHOE Face Body Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46d36f60-2a5d-816e-e063-6294a90a2ddc | 2025-12-26 | Warnings | M020 |
| OUHOE Bean Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46d3b11f-93d9-0e38-e063-6294a90a41c3 | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e922d89c-4232-77d8-e053-2995a90a85e5 | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e9231470-9292-0e70-e053-2a95a90a767a | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e92288bb-739a-2f73-e053-2995a90ac01f | 2025-12-26 | Warnings | M020 |
| StriVectin-SH NIA-114 UVA UVB Shields SPF 30 | HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONE | StriVectin Operating Company Inc. | 232cbde4-d8ea-4831-9b44-c2e93203260a | 2025-12-26 | Warnings | M020 |
| Cardon | AVOBENZONE, HOMOSALATE, OCTYL SALICYLATE | Cardon, Inc | 72ee2c06-242e-29a2-e053-2991aa0ad8dc | 2025-12-26 | Warnings | M020 |
| OUHOE Water-Permeable Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46e63e1e-7851-ca26-e063-6394a90a9b53 | 2025-12-26 | Warnings | M020 |
| OUHOE Sun Milk | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46e678dd-13c5-b317-e063-6294a90aa989 | 2025-12-26 | Warnings | M020 |
| Dermatone Sport SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Dermatone Labs LLC | 0e60e5bb-b941-4114-933a-29480bff5960 | 2025-12-24 | Warnings | M020 |
| Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Natural | AVOBENZONE, OCTISALATE, OCTINOXATE | Intelligent Elixirs, LLC | 287a61d8-0056-6211-e063-6394a90aa3da | 2025-12-24 | Warnings | M020 |
| Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the face | HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452b5997-d229-60ee-e063-6394a90a68db | 2025-12-23 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63354-319-16 | 63354031916 | 236 g in 1 BOTTLE, PUMP (63354-319-16) | 236 g | 2023-11-30 | 2027-09-11 | No | No | Historical |