Home NDC 63354-260-16 Hawaiian Tropic
Product NDC 63354-260
Requested package NDC 63354-260-16
11-digit product format 633540260
Labeler code 63354
Product ID 63354-260_5d04e45a-9d01-4fb3-e053-2991aa0ace3e
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, homosalate, octisalate, octocrylene, oxybenzone
Dosage form OIL
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-12-03
Marketing end 0000-00-00
Substance AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE
Active strength 3 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 ARGININE INACTIVE INGREDIENT 94ZLA3W45F HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 BETA CAROTENE INACTIVE INGREDIENT 01YAE03M7J HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 CARROT INACTIVE INGREDIENT L56Z1JK48B HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 COLOCASIA ESCULENTA ROOT INACTIVE INGREDIENT H7B71Q0G0D HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 CORN OIL INACTIVE INGREDIENT 8470G57WFM HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 D&C RED NO. 17 INACTIVE INGREDIENT ND733RX3JN HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 D&C YELLOW NO. 11 INACTIVE INGREDIENT 44F3HYL954 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 DIISOPROPYL ADIPATE INACTIVE INGREDIENT P7E6YFV72X HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 ETHYLHEXYL PALMITATE INACTIVE INGREDIENT 2865993309 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 GUAVA INACTIVE INGREDIENT 74O70D6VG0 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 HISTIDINE INACTIVE INGREDIENT 4QD397987E HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 MANGO INACTIVE INGREDIENT I629I3NR86 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 OCTYLDODECANOL INACTIVE INGREDIENT 461N1O614Y HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 PAPAYA INACTIVE INGREDIENT KU94FIY6JB HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 PASSIFLORA INCARNATA FRUIT INACTIVE INGREDIENT SF206I8G4P HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 PEG-8 DIMETHICONE INACTIVE INGREDIENT GIA7T764OD HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 PHENYL TRIMETHICONE INACTIVE INGREDIENT DR0K5NOJ4R HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 PLUMERIA RUBRA FLOWER INACTIVE INGREDIENT 8P7XXY759H HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 POLYBUTENE (1400 MW) INACTIVE INGREDIENT 1NA5AO9GH7 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 TARTARIC ACID INACTIVE INGREDIENT W4888I119H HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) OIL [ENERGIZER PERSONAL CARE LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63354-260-16 63354026016 214 g in 1 BOTTLE, SPRAY (63354-260-16) 214 g 2012-12-03 0000-00-00 No No Current