FDA.reportPublic FDA data

HAWAIIAN TROPIC

Product NDC
63354-625
11-digit product format
633540625
Labeler code
63354
Product ID
63354-625_edff2e3c-f753-05fd-e053-2995a90a8b75
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-01-01
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTOCRYLENE
Active strength
1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63354-625DDiscontinued by firm2026-10-20
excluded packagepackage63354-62563354-625-56DDiscontinued by firm2026-10-20

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.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct63354-625DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-62563354-625-56DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
COLOCASIA ESCULENTA ROOTINACTIVE INGREDIENTH7B71Q0G0DHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72XHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
GUAVAINACTIVE INGREDIENT74O70D6VG0HAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
MANGOINACTIVE INGREDIENTI629I3NR86HAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PAPAYAINACTIVE INGREDIENTKU94FIY6JBHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PASSIFLORA INCARNATA FRUITINACTIVE INGREDIENTSF206I8G4PHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3THAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PLUMERIA RUBRA FLOWERINACTIVE INGREDIENT8P7XXY759HHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [ENERGIZER PERSONAL CARE LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-625HAWAIIAN TROPIC (AVOBENZONE, OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]8Legacy NDC20241102_a7c9d671-03aa-4b92-87c2-129852dbb1f9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-625-5663354062556236 g in 1 BOTTLE, PLASTIC (63354-625-56) 236 g2012-01-010000-00-00NoNoCurrent