FDA.reportPublic FDA data

HAWAIIAN TROPIC

Product NDC
63354-062
11-digit product format
633540062
Labeler code
63354
Product ID
63354-062_5de3225b-b579-3099-e063-6294a90af870
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-06
Marketing end
2028-10-01
Substance
OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE
Active strength
4.5; 4; 8; 2.7 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE4.5 g/100g
OCTISALATE4 g/100g
HOMOSALATE8 g/100g
AVOBENZONE2.7 g/100g

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 144 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Tinted Foaming Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE AESTHETICS ACADEMY, LLC3698c076-68b1-7d28-e063-6394a90a517c2025-12-09Exact identifier
application number: M020
Non-Tinted Replenishing Daily ProtectionZINC OXIDETHE AESTHETICS ACADEMY, LLC3699159a-3561-9ff6-e063-6394a90af9fd2025-12-09Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c1723-fb1d-ae3c-e063-6294a90a46092025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Satin Dewy FinishZINC OXIDETRU SKIN RITUALS3249d05b-0f5c-4787-e063-6294a90aa0d72025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c3a18-ba8f-912d-e063-6394a90a24472025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c8641-1161-b8ac-e063-6394a90ae4512025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Silk Matte FinishTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS3248eb22-1e10-2091-e063-6394a90ad3e12025-12-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325cce54-a885-d586-e063-6394a90a90db2025-12-09Exact identifier
application number: M020
Sheer Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS324acd75-9c38-4adc-e063-6394a90afa122025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Satin Dewy FinishZINC OXIDETRU SKIN RITUALS324960e6-c1e7-d2b9-e063-6294a90a92ce2025-12-09Exact identifier
application number: M020
Sol Purpose Mineral Sunscreen TintedZINC OXIDETRU SKIN RITUALS324a3475-07f0-033c-e063-6394a90a811a2025-12-09Exact identifier
application number: M020
Perfect Sunscreen SPF 50 Sheer MineralZINC OXIDEBluemercury, Inc.d8f483ff-b990-40c5-b5b8-00065051ae7e2025-12-09WarningsExact identifier
application number: M020
Foto Facial Age Delay Non-TintedTITANIUM DIOXIDE ZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42674013-fa2b-42d7-e063-6294a90af9992025-12-09WarningsExact identifier
application number: M020
Hydraboost Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBluemercuryeca867e6-4deb-4be2-ae3f-6850fb6223b32025-12-09WarningsExact identifier
application number: M020
Foto Facial Age Delay Matte TintedTITANIUM DIOXIDE ZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42761919-8ae2-3c41-e063-6394a90abb8f2025-12-09WarningsExact identifier
application number: M020
Dew MineralZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42f17245-92a9-3915-e063-6394a90a68172025-12-09WarningsExact identifier
application number: M020
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c69b707-07ff-1a82-e063-6394a90a9fcd2025-12-09WarningsExact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c69f93f-0385-365c-e063-6394a90a12fd2025-12-09WarningsExact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c6a5601-a7a2-5e20-e063-6394a90a66432025-12-09WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC124ca946-8412-4d6d-e063-6294a90a63382025-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-062-5463354006254177 g in 1 BOTTLE (63354-062-54) 177 g2026-01-062028-10-01NoNoHistorical