FDA.reportPublic FDA data

HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70

Product NDC
63354-083
11-digit product format
633540083
Labeler code
63354
Product ID
63354-083_463fdceb-5058-32e9-e063-6294a90a3bf2
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
2022-10-01
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
9.5; 4.7; 7.5; 2.8 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 SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE9.5 g/100g
OCTISALATE4.7 g/100g
OCTOCRYLENE7.5 g/100g
AVOBENZONE2.8 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e686a22f-bddc-5d7c-e053-2995a90a7b28Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-083-34HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70170 g in 1 CANAEROSOL, SPRAY1705

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-083HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, Legacy NDC, 1 package rows20231026_e686a22f-bddc-5d7c-e053-2995a90a7b28.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 63 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Poolside Golden Hour SPF 15 Sunscreen LipHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC7d0f8319-f0fa-4ea7-bb66-427c5a78145a2026-02-10WarningsExact identifier
application number: M020
Tanri Broad Spectrum SPF 30SUNSCREENI. Shay Cosmetics26d5b9d1-d669-3430-e063-6394a90ad7f22026-02-10WarningsExact identifier
application number: M020
DAILY SUNSCREEN BROAD SPECTRUM SPF 30ZINC OXIDES+9d6ffe56-debc-4ad2-837b-fd7bb091a56f2026-02-09WarningsExact identifier
application number: M020
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
application number: M020
Solavida Broad Spectrum Mineral Sunscreen SPF 30 - FaceZINC OXIDESolavida, LLC4a694cdf-496b-3bc0-e063-6294a90af0d12026-02-09WarningsExact identifier
application number: M020
numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBENOW BEAUTY INC32bfb17c-5535-c016-e063-6394a90a18142026-02-09WarningsExact identifier
application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4a6b69ed-2739-d22a-e063-6294a90a1e522026-02-09WarningsExact identifier
application number: M020
SUNPLUS LIP LIFESUNSCREENI. Shay Cosmetics26d28286-e812-0fb3-e063-6394a90a338d2026-02-09WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbb86322d-ff30-4a54-97b5-1be2750671462026-02-06WarningsExact identifier
application number: M020
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
application number: M020
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
application number: M020
SHISEIDO WASO SHIKULIME COLOR CONTROLAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Shiseido Americas Corporationf225a736-2ff7-4084-88a4-a8df5b043cce2026-02-06WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmerican Sales Company79dff6ec-d958-4bba-999b-da4aa67519f52026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneSUNSCREENRetail Business Services, LLC1dc325bb-d520-4897-b8f8-3f0ecba2274c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCd8a55217-ae50-4c7f-a440-f4de079d08ae2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 100AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCf2a4b432-118e-42a4-baeb-90614dccbd062026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC232ab407-1903-45d8-a2b2-6992ffd30d002026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC0ccef180-0eb1-cf2b-e063-6394a90adf0c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6a455f1a-4285-44c3-820a-85a50d1bbc5b2026-02-06WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC15bf22f5-a8f5-44bb-b787-2b762b330d612026-02-06Warnings, Adverse reactionsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-083-3463354008334170 g in 1 CAN (63354-083-34) 170 g2022-10-010000-00-00NoNoCurrent