Home NDC 58411-965 SHISEIDO WASO SHIKULIME COLOR CONTROL
Product NDC 58411-965
11-digit product format 584110965
Labeler code 58411
Product ID 58411-965_4a2b2478-2079-d61d-e063-6394a90a67a4
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,
Dosage form CREAM
Route TOPICAL
Labeler Shiseido Americas Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 1.24959; 5.433; 2.7165; 2.7165 g/50mL; g/50mL; g/50mL; g/50mL
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 SHISEIDO WASO SHIKULIME COLOR CONTROL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 1.24959 g/50mL HOMOSALATE 5.433 g/50mL OCTISALATE 2.7165 g/50mL OCTOCRYLENE 2.7165 g/50mL
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 58411-965-60 SHISEIDO WASO SHIKULIME COLOR CONTROL 1 in 1 BOX CREAM 1 2 58411-965-60 SHISEIDO WASO SHIKULIME COLOR CONTROL 50 mL in 1 TUBE CREAM 50 2
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 Status 58411-965-60 58411096560 1 in 1 BOX Historical