Home NDC 63354-054 Hawaiian Tropic Everyday Active SPF30
Product NDC 63354-054
11-digit product format 633540054
Labeler code 63354
Product ID 63354-054_5de3ec14-4c4d-0942-e063-6394a90a78cc
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,HOMOSALATE,OCTOCRYLENE
Dosage form LOTION
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-13
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength 2.2; 7; 4.2 g/100g; 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 Everyday Active SPF30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.2 g/100g HOMOSALATE 7 g/100g OCTOCRYLENE 4.2 g/100g
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63354-054-56 Hawaiian Tropic Everyday Active SPF30 236 g in 1 BOTTLE LOTION 236 3 63354-054-57 Hawaiian Tropic Everyday Active SPF30 319 g in 1 BOTTLE LOTION 319 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-054 HAWAIIAN TROPIC EVERYDAY ACTIVE SPF30 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231201_dc8d42f9-a619-3f84-e053-2a95a90a8cc7.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63354-054-56 63354005456 236 g in 1 BOTTLE (63354-054-56) 236 g 2022-04-13 0000-00-00 No No Current 63354-054-57 63354005457 319 g in 1 BOTTLE (63354-054-57) 319 g 2022-04-13 0000-00-00 No No Current