HAWAIIAN TROPIC

Product NDC
63354-613
11-digit product format
633540613
Labeler code
63354
Product ID
63354-613_3fe8332b-e3f9-a32c-e063-6294a90a252a
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-31
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
2; 6; 6; 4.5 g/100g; 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
AVOBENZONE2 g/100g
HOMOSALATE6 g/100g
OCTOCRYLENE6 g/100g
OCTISALATE4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08f3b27f-b233-d406-e063-6394a90ada76Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-613-34HAWAIIAN TROPIC170 g in 1 CANAEROSOL, SPRAY1703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-613HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]2Current NDC, 1 package rows20250410_08f3b27f-b233-d406-e063-6394a90ada76.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 318 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172d584-7cb6-a078-e053-2995a90ac78f2023-12-05WarningsExact identifier
application number: M020
EltaMD UV SheerZINC OXIDE AND OCTOCRYLENE SUNSCREENCP Skin Health Group, Inc.2564e811-70f5-4d00-be8e-686b55e316302023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1720cff-a897-68cb-e053-2995a90a30b62023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4ed-2212-e053-2995a90add372023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12272c3-d4f0-2212-e053-2995a90add372023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228ca6-8fb4-5964-e053-2a95a90a30ca2023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c12292a8-c98f-eb27-e053-2a95a90a9bbc2023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172d22a-0315-8e84-e053-2995a90a30b52023-12-05WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Honest Company, Inc.c172cabe-faab-6458-e053-2995a90aef662023-12-05WarningsExact identifier
application number: M020
Sea Clearly Translucent Gel Sunscreen BS SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAllure Labs0bb4ec66-64ba-9583-e063-6394a90ac5122023-12-04WarningsExact identifier
application number: M020
Clearly Zinq Mineral Gel Sunscreen BS SPF 60ZINC OXIDEAllure Labs0bb7f0a4-13df-7734-e063-6294a90a242b2023-12-04WarningsExact identifier
application number: M020
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skinTITANIUM DIOXIDE, ZINC OXIDERodan & Fieldsb7401ff8-ca47-4c74-813c-99c5f28c0b6d2023-12-04WarningsExact identifier
application number: M020
Eminence Bright Skin Moisturizer SPF 40 SunscreenZINC OXIDEEminence Organic Skin Care4f2ba93d-ec19-40c1-b4ca-53898841f55b2023-12-02WarningsExact identifier
application number: M020
Lilikoi Mineral Defense Sport Sunscreen SPF 30ZINC OXIDEEminence Organic Skin Care Ltd.5375522a-17e3-48a1-8248-dd811c3823bf2023-12-02WarningsExact identifier
application number: M020
Eminence Lilikoi Daily Defense Moisturizer SPF 40 SunscreenZINC OXIDEEminence Organic Skin Careedc9972a-affd-4099-aec1-3549a07fa83c2023-12-02WarningsExact identifier
application number: M020
Perbelle CC SPF43 UVA UVB Broad SpectrumTITANIUM DIOXIDEPerbelle Cosmetics Global Ltd.b5e2724e-9806-5bcc-e053-2a95a90a05082023-12-01WarningsExact identifier
application number: M020
A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.abd8b302-a01c-478d-919a-22e686cb88da2023-12-01WarningsExact identifier
application number: M020
SHADE and ILLUMINATE SOFT RAD PRMR SPFOCTINOXATE,OCTISALATE,ZINC OXIDETOM FORD BEAUTY DISTeac7d416-c243-4647-e053-2a95a90abcb72023-12-01WarningsExact identifier
application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Honest Company, Inc.c1228d15-a157-6989-e053-2995a90a44ea2023-12-01WarningsExact identifier
application number: M020
CAO Cosmetic Lip Sunscreen SPF 30AVOBENZONE, OCTOCRYLENES & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITEDd912b9e9-f351-e2b0-e053-2a95a90a9ca22023-11-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-613-3463354061334170 g in 1 CAN (63354-613-34) 170 g2023-10-31NoNoCurrent