Home NDC 54473-404 Sun Shades Sunscreen
Product NDC 54473-404
11-digit product format 544730404
Labeler code 54473
Product ID 54473-404_46903e8d-f15c-5ddc-e063-6394a90a354e
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, homosalate, octisalate, octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Melaleuca Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-05-01
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE
Active strength 13.04; 8.15; 4.89; 24.45 g/163mL; g/163mL; g/163mL; g/163mL
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 Sun Shades Sunscreen
Brand name suffix Sunscreen SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 13.04 g/163mL OCTISALATE 8.15 g/163mL AVOBENZONE 4.89 g/163mL HOMOSALATE 24.45 g/163mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 54473-404-01 Sun Shades SunscreenSunscreen SPF 50 163 mL in 1 BOTTLE, SPRAY SPRAY 163 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-404 SUN SHADES SUNSCREEN SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA INC.] 1 Current NDC, 1 package rows 20240829_1f982f03-9542-29f9-e063-6294a90a959c.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 Sample Exclude flag Status 54473-404-01 54473040401 163 mL in 1 BOTTLE, SPRAY (54473-404-01) 163 ml 2020-05-01 No No Current