Hawaiian Tropic

Product NDC
63354-693
11-digit product format
633540693
Labeler code
63354
Product ID
63354-693_5de5e42c-7782-6f9d-e063-6294a90a60be
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Octisalate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-10-01
Substance
OCTISALATE; AVOBENZONE
Active strength
4; .5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4 g/100g
AVOBENZONE.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal 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
5de5e422-76b4-6abb-e063-6294a90a230eAvailable on FDA.report

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 80 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30ZINC OXIDENew Frontier Bio, Incef6c8443-fd10-2022-e053-2a95a90a45ea2026-01-13WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC2e5315bf-39f4-401c-8207-18ef6a97e0242026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical SPF 45TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe20f5dc9-e863-b090-e053-2a95a90a50442026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical Clear SPF 50TITANIUM DIOXIDE, ZINC OXIDERevision, LLC1305fa94-47d5-7a42-e063-6394a90a0aba2026-01-13WarningsExact identifier
application number: M020
Intellishade Clear SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATERevision, LLCe213b46d-d061-dc83-e053-2995a90ad8752026-01-13WarningsExact identifier
application number: M020
Intellishade Matte SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213ae87-4db2-3070-e053-2995a90a083b2026-01-13WarningsExact identifier
application number: M020
Sun Project MoistureHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a83f02-d851-4aac-e063-6394a90ae1a62026-01-13WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project SoothingHOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a60051-d57c-a341-e063-6394a90a92432026-01-13WarningsExact identifier
application number: M020
Sun GuardZINC OXIDESaje Natural Business Inc87ee593d-668c-f592-e053-2a95a90a17b12026-01-13WarningsExact identifier
application number: M020
Vixin Beach Face Sunscreen SPF50ZINC OXIDEVeganic SKN Limited482ae347-d175-52f2-e063-6394a90a92b02026-01-12WarningsExact identifier
application number: M020
FRE Glow ME Lightweight Tinted MoisturizerZINC OXIDEPeer Pharm Ltd1cf5b24a-e6fd-470a-e063-6294a90ab29c2026-01-12WarningsExact identifier
application number: M020
Botao Baby Mineral Sunscreen LZINC OXIDEPeer Pharm Ltd.e1564df9-90cb-0b1f-e053-2a95a90acb5e2026-01-12WarningsExact identifier
application number: M020
FRE GLOW ME SPF 50 Lightweight Tinted Moisturizer Medium DeepZINC OXIDEPeer Pharm Ltd1d4559e7-91d4-6c85-e063-6394a90af8952026-01-12WarningsExact identifier
application number: M020
Sun and Shine - Mineral Sunscreen Clear Facial Stick SPF 50ZINC OXIDEPeer Pharm Ltd.20755fd4-ad05-4de2-84f5-fb29c0c5b1042026-01-12WarningsExact identifier
application number: M020
Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 50ZINC OXIDEPeer Pharm Ltd.75763dc1-c762-42fc-a8fe-4d9d7bde0ce62026-01-12WarningsExact identifier
application number: M020
SUN and SHINE MINERAL SUNSCREENZINC OXIDEPeer Pharm Ltd.897eb75c-d7d6-4fce-afdd-f794fd8a82fd2026-01-12WarningsExact identifier
application number: M020
LINOZINC OXIDELino Cosmetics LLC262ef129-9453-2411-e063-6294a90ae2232026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50ZINC OXIDECrown Laboratoriesbb101039-dd3c-46da-e053-2a95a90aff8b2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50ZINC OXIDECrown Laboratoriesbfefb252-7e37-4675-e053-2995a90acb932026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50ZINC OXIDECrown Laboratoriesbfefb36b-0858-6e4d-e053-2a95a90a01ce2026-01-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-693-1663354069316236 g in 1 BOTTLE, PUMP (63354-693-16) 236 g2026-10-01NoNoCurrent