Hawaiian Tropic
- Product NDC
- 63354-927
- Requested package NDC
- 63354-927-54
- 11-digit product format
- 633540927
- Labeler code
- 63354
- Product ID
- 63354-927_767accea-c5b3-32dc-e053-2991aa0a3338
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Edgewell Personal Care Brands LLC
- Application
- part352
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2018-10-15
- Marketing end
- 0000-00-00
- Substance
- HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
- Active strength
- 6 g/100g; g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63354-927 | 63354-927-54 | D | Discontinued by firm | 2026-11-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 63354-927 | 63354-927-54 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63354-927 | 63354-927-54 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63354-927 | 63354-927-54 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63354-927-54 | 2023-10-20 | C162847 | 48780-1 | d6a99b39-4f1d-a426-e053-dadaa90af4c2 | 767accea-c5b2-32dc-e053-2991aa0a3338 |
| 63354-927-54 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4f1d-a426-e053-dadaa90af4c2 | 767accea-c5b2-32dc-e053-2991aa0a3338 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63354-927-54 | Hawaiian Tropic | 177 g in 1 TUBE | LOTION | 177 | 3 |
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 | 767accea-c5b2-32dc-e053-2991aa0a3338 | 2024-10-31 | Warnings | 63354-927-54 63354-927 63354092754 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63354-927-54 | 63354092754 | 177 g in 1 TUBE (63354-927-54) | 177 g | 2018-10-15 | 0000-00-00 | No | No | Current |