HAWAIIAN TROPIC

Product NDC
63354-784
11-digit product format
633540784
Labeler code
63354
Product ID
63354-784_3fe83a06-b046-ac3b-e063-6294a90a3b37
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
2025-04-02
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
4.5; 2.7; 9 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4.5 g/100g
AVOBENZONE2.7 g/100g
OCTOCRYLENE9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31d01fae-4085-d84a-e063-6294a90ab981Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-784-16HAWAIIAN TROPIC236 g in 1 BOTTLE, PUMPOIL2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-784HAWAIIAN TROPIC (AVOBENZONE,OCTISALATE,OCTOCRYLENE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20250406_31d01fae-4085-d84a-e063-6294a90ab981.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.

Matched openFDA labels page 30 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SP-FFC3-L0TN Barrier Protection Hydrating Mineral Face SunscreenBARRIER PROTECTION HYDRATING MINERAL FACE SUNSCREENEpic Etailers, LLC (DBA: Beauty by Earth)5078479e-a196-7e4d-e063-6394a90ab2662026-05-19WarningsExact identifier
application number: M020
InvisibleMatteBarrierDefenseCeramideSunscreenSerumSPF30SP-FSRM-N0TTINVISIBLE MATTE BARRIER DEFENSE CERAMIDE SUNSCREEN SERUM SPF 30Epic Etailers, LLC (DBA: Beauty by Earth)50790945-f359-07c8-e063-6294a90a5af92026-05-19WarningsExact identifier
application number: M020
Sun Bum Amazon 8 OZ SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum522fc8a4-ce9f-8be8-e063-6294a90aebf02026-05-19WarningsExact identifier
application number: M020
Timesavvy Hybrid Sheer Sun Serum Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEPROBETTER USA INC.66624df4-cb6c-4cfb-bbbe-9f885f2ad7782026-05-18WarningsExact identifier
application number: M020
Hampton Sun SPF 50AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 %S&C Hampton Sun LLC4df050f9-1185-4ee4-a0cd-84ba9d254e582026-05-18Exact identifier
application number: M020
Hampton Sun SPF 70 KidsAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLC7c976082-3265-4c0b-9985-277d279888952026-05-18WarningsExact identifier
application number: M020
Evereden Kids Cooling Mineral Sunstick SPF30ZINC OXIDEEden Brands Inc.521afa81-737f-81d4-e063-6394a90ad3072026-05-18WarningsExact identifier
application number: M020
cle de peau BEAUTE RESTORATIVE DAY SUPREMEAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporation157e52c5-f6fa-430b-bbb8-86b7c0868ad32026-05-18WarningsExact identifier
application number: M020
cle de peau BEAUTE SKIN BEAUTY ENHANCERAVOBENZONE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationbc6230f1-dba2-4418-b48c-c5e67aebd1bd2026-05-18WarningsExact identifier
application number: M020
Hampton Sun SPF 30 SILK BODYAVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENES&C Hampton Sun LLCed0c184d-473a-4c4c-b6ec-e1d79ad584602026-05-18WarningsExact identifier
application number: M020
Sheer Defense Tinted SPF 46ZINC OXIDE, OCTINOXATEPrivate Label Skin Care017265e9-31e6-43ce-9432-cb88f471c4962026-05-18WarningsExact identifier
application number: M020
Aveeno Daily Moisturizing Face Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC51d59378-df72-e438-e063-6294a90a97f12026-05-15WarningsExact identifier
application number: M020
Natural Sense SPF 50 SunscreenSUNSCREENDr. Natural LLC49a2430e-c15b-4610-e063-6294a90ac5202026-05-15WarningsExact identifier
application number: M020
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc.23cc5ff4-f842-4e3e-ac5c-23dbaf7d39142026-05-15WarningsExact identifier
application number: M020
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUMTITANIUM DIOXIDE AND ZINC OXIDESICOS ET CIEc688f8e6-2cd2-40db-b03f-90fd74c2d89c2026-05-15WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
application number: M020
Target Up and Up Ultra Light Dry-Touch SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51de3d0b-2721-92d3-e063-6394a90a18bb2026-05-15WarningsExact identifier
application number: M020
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 8 Bronze SunscreenHOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%S&C Hampton Sun LLC7cf4d943-be6e-4e38-8891-1e0b22af55362026-05-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-784-1663354078416236 g in 1 BOTTLE, PUMP (63354-784-16) 236 g2025-04-02NoNoCurrent