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 |
|---|---|---|---|---|---|---|
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 228fab45-e0d2-f219-e063-6294a90a1ef6 | 2026-01-05 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 228055ec-ff59-4412-e063-6394a90abe14 | 2026-01-05 | Warnings | M020 |
| SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 236bdb53-d7a5-43a2-8a0c-bce4a5522e26 | 2026-01-05 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 4bd99626-690b-49e8-8c42-a2e2dbca09bf | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE LONG-LASTING HYDRATING VEIL | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f04ece6c-66b6-48e9-8f6b-e898a538ba00 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FOUNDATION N I10 | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 05ffb157-5e28-4e94-866d-9e3371480d84 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE CONCEALER N 1 | TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | eedf8065-8897-4773-9cbb-bab57d2dd04f | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE BRIGHTENING ENHANCER VEIL | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | bb00d6d7-cc51-4fee-a0df-68bbd5bc50d6 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | beefe840-6f32-483b-8a37-2696adb8eea1 | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25 | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | addd9885-362c-4ce0-9a6e-759e71d8756c | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 65ca1240-6ee8-40c0-b62f-3597e0872c6e | 2026-01-05 | Warnings | M020 |
| cle de peau BEAUTE CORRECTING VEIL n M | ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 15a258a0-61c3-4419-bcdb-a8197d5ae46f | 2026-01-05 | Warnings | M020 |
| Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | LG H&H Co.,Ltd. | 098c0a9b-2b96-6be3-e063-6294a90a959a | 2026-01-05 | Warnings | M020 |
| Poolside Butter Screen SPF 30 Sunscreen Butter | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | ae838725-79ab-4c17-905b-d4138ad6af1f | 2026-01-05 | Warnings | M020 |
| Poolside Bronze Service Instant Bronzing Sunscreen SPF 30 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE | I World LLC | b98a9cec-3c48-4614-b091-4e59fa7d196e | 2026-01-05 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen Oil Mist | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | I World LLC | 5a9f8888-529d-40d7-9489-baa5ff657cb4 | 2026-01-05 | Warnings | M020 |
| Yon-Ka 50 Mineral Fluid | ZINC OXIDE | Laboratoire MULTALER Yon-Ka | 47a8c8b2-30ff-0d40-e063-6294a90ac461 | 2026-01-05 | Warnings | M020 |
| SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E | OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 6d2f82d5-b3af-44af-b6b0-de96a4cd95fc | 2026-01-05 | Warnings | M020 |
| SHISEIDO SPORTS BB LIGHT | OCTINOXATE AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 260a3eab-8fe6-4259-8dcc-3706ca1f6881 | 2026-01-05 | Warnings | M020 |
| SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATE | SHISEIDO AMERICAS CORPORATION | 4a16dbb7-e860-4aae-8e8b-67abbe8295bd | 2026-01-05 | 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 |