Home NDC 63354-520 Hawaiian Tropic Lip Balm Sunscreen SPF 30
Product NDC 63354-520
11-digit product format 633540520
Labeler code 63354
Product ID 63354-520_47ba86ad-2409-e733-e063-6394a90a24e3
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,OCTISALATE,OCTOCRYLENE
Dosage form STICK
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-01
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength 10; 5; 3 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 Lip Balm Sunscreen SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 10 g/100g OCTISALATE 5 g/100g AVOBENZONE 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup 4X49Y0596W Internal UNII lookup G63QQF2NOX Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63354-520-61 Hawaiian Tropic Lip Balm Sunscreen SPF 30 4.25 g in 1 CYLINDER STICK 4.25 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-520 HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30 (AVOBENZONE,OCTISALATE,OCTOCRYLENE) STICK [EDGEWELL PERSONAL CARE BRANDS LLC] 3 Current NDC, Legacy NDC, 1 package rows 20231025_c7b71be3-f906-bd09-e053-2995a90adc61.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 63354-520-61 63354052061 4.25 g in 1 CYLINDER (63354-520-61) 4.25 g 2021-09-01 0000-00-00 No No Current