Home NDC 81104-802 HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50
Product NDC 81104-802
11-digit product format 811040802
Labeler code 81104
Product ID 81104-802_31bad2aa-3719-1b84-e063-6394a90ae385
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, Homosalate OCTISALATE,
Dosage form CREAM
Route TOPICAL
Labeler NAKED SUNDAYS PTY LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-30
Substance AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength 3; 10; 5 g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50
Brand name suffix SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 10 g/100mL OCTISALATE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81104-802-01 HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50SPF 50 50 mL in 1 CONTAINER CREAM 50 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81104-802 HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50 (AVOBENZONE, HOMOSALATE OCTISALATE,) CREAM [NAKED SUNDAYS PTY LTD] 6 Current NDC, 1 package rows 20250403_04293280-e74a-f293-e063-6394a90a06f6.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 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81104-802-01 81104080201 50 mL in 1 CONTAINER (81104-802-01) 50 ml 2023-08-30 No No Current