FDA.reportPublic FDA data

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 10 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARKZINC OXIDEYounique, LLC2173666b-6c72-449d-9f40-098ea174f3e12026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEPZINC OXIDEYounique, LLC360ceb90-bec6-4fec-820a-a4d65008b8722026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEPZINC OXIDEYounique, LLC86c33a9e-9132-4377-8688-41e5844de62c2026-07-23WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTUREAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.edbfcf21-96c6-4519-8b08-f9b5ada7d1d72026-07-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO NUDE SKIN BASE SERUM TINT COBERTURA ANTIMANCHAS FPS 15 ANTI DARK SPOT COVERAGE SERUM TINT FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.574c96e9-77a2-778f-e063-6394a90a0aae2026-07-23WarningsExact identifier
application number: M020
SKINSUIT LIP SPF 30ZINC OXIDESkin Authority LLCcb24d714-f6cd-4518-b146-627cfe6c2ccd2026-07-23WarningsExact identifier
application number: M020
SKINSUIT FACE SPF 50ZINC OXIDESkin Authority LLC389fc528-fda5-485a-ab37-f99fcf3ed0b32026-07-23WarningsExact identifier
application number: M020
Sun Zapper - Pure Zinc Anti Mozzie Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3cd83dba-2008-bef6-e063-6294a90aad952026-07-23WarningsExact identifier
application number: M020
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
application number: M020
Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3519e5bc-8c07-0617-e063-6394a90a65ae2026-07-22WarningsExact identifier
application number: M020
Tula Skincare Radiant Skin Brightening Serum Skin Tint Broad Spectrum SPF 30 01 Very Light NeutralAVOBENZONE, AND OCTISALATEThe Procter & Gamble Manufacturing Company366144c4-ec80-e435-e063-6394a90aba542026-07-22WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
application number: M020
YSE Beauty Instant Glow TrioAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLC6742e089-565a-40bc-8ffa-ec06e79860282026-07-21WarningsExact identifier
application number: M020
YSE Beauty The Roadies Packable AM RoutineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLCb0844331-d277-4cfb-957a-d8f9498836842026-07-21WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEBCM Cosmetique SAS328f96bc-fb68-33dc-e063-6294a90aecfa2026-07-21WarningsExact identifier
application number: M020
Sunscreen In the Raw SPF 50ZINC OXIDEBiomin LLC625523f0-366f-4148-b927-d726b7d1b9f42026-07-20WarningsExact identifier
application number: M020
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3a87ddee-241d-f972-e063-6294a90a7e892026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Daily Face Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a893b13-e7f5-c5b1-e063-6394a90a42532026-07-20WarningsExact identifier
application number: M020
Omnilux Mineral Facial SunscreenZINC OXIDEThe Lotus Global Group, Inc, dba GlobalMed Technologies5710c84b-9d6b-da4d-e063-6394a90a07372026-07-20WarningsExact 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