Hawaiian Tropic Lip Balm Sunscreen SPF 30
- Product NDC
- 63354-520
- 11-digit product format
- 633540520
- Labeler code
- 63354
- Product ID
- 63354-520_47ba86ad-2409-e733-e063-6394a90a24e3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AVOBENZONE,OCTISALATE,OCTOCRYLENE
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- Edgewell Personal Care Brands LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-09-01
- Substance
- OCTOCRYLENE; OCTISALATE; AVOBENZONE
- Active strength
- 10; 5; 3 g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Lip Balm Sunscreen SPF 30
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTOCRYLENE | 10 g/100g |
| OCTISALATE | 5 g/100g |
| AVOBENZONE | 3 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5A68WGF6WM | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c7b71be3-f906-bd09-e053-2995a90adc61 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63354-520-61 | Hawaiian Tropic Lip Balm Sunscreen SPF 30 | 4.25 g in 1 CYLINDER | STICK | 4.25 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63354-520 | HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30 (AVOBENZONE,OCTISALATE,OCTOCRYLENE) STICK [EDGEWELL PERSONAL CARE BRANDS LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231025_c7b71be3-f906-bd09-e053-2995a90adc61.zip |
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 |
|---|---|---|---|---|---|---|
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e4e63c-3e51-0a78-e053-2a95a90abd87 | 2025-11-04 | Warnings | M020 |
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 8cd68b09-2578-4519-b00e-e83e0e440815 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e44be7-3a46-34e2-e053-2a95a90a9660 | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 005a9e7c-e392-4b9a-911f-d7586f7ae94e | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559d349-2ffd-492c-e053-2995a90aab06 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pink Beach | ZINC OXIDE | Tropical Seas, Inc. | d240e6c9-d053-9924-e053-2a95a90a855a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e49c6f-477b-aafc-e053-2a95a90a982a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559e03b-f5d3-bd72-e053-2995a90a31ca | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 Clear Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d128269b-73fa-e5f3-e053-2995a90af1ed | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 Sport | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e40a7c-b49d-cfc3-e053-2995a90ac27e | 2025-11-04 | Warnings | M020 |
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | d5ed3488-aa32-4a63-9996-12c6532c3a4d | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559499c-6109-bf5e-e053-2995a90a4ac7 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e24ca1-d041-355d-e053-2995a90a3d61 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5570cbd-89f5-65d5-e053-2995a90a54d1 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Azure Blue | ZINC OXIDE | Tropical Seas, Inc. | d23fe61a-3ffb-59d0-e053-2995a90a59e6 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b55a0bd0-2a32-2977-e053-2a95a90aa142 | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | 06d43525-86d8-f2d9-e063-6394a90afc81 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pacific Purple | ZINC OXIDE | Tropical Seas, Inc. | d240fe7c-9d16-78c9-e053-2a95a90a763c | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 06c1ac52-474c-db5c-e063-6294a90afb5f | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 Tinted Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d1287899-f178-6124-e053-2a95a90a95a5 | 2025-11-04 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63354-520-61 | 63354052061 | 4.25 g in 1 CYLINDER (63354-520-61) | 4.25 g | 2021-09-01 | 0000-00-00 | No | No | Current |