Home NDC 54181-009 HYDRA BEAUTE SPF 15
Product NDC 54181-009
11-digit product format 541810009
Labeler code 54181
Product ID 54181-009_5b1ceef6-edfc-56ad-e063-6394a90a9e21
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Dosage form CREAM
Route TOPICAL
Labeler Guinot
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-01-01
Marketing end 2027-02-01
Substance AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength 28.5; 50; 70; 30; 90 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
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 HYDRA BEAUTE SPF 15 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 28.5 mg/mL HOMOSALATE 50 mg/mL OCTINOXATE 70 mg/mL OCTISALATE 30 mg/mL OCTOCRYLENE 90 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
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 54181-009-50 HYDRA BEAUTE SPF 15 1 in 1 BOX CREAM 1 5 54181-009-50 HYDRA BEAUTE SPF 15 50 mL in 1 TUBE CREAM 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54181-009 HYDRA BEAUTE SPF 15 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) CREAM [GUINOT] 4 Current NDC, Legacy NDC, 2 package rows 20231020_806d1e18-a3fc-43df-a52a-a640902d0887.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 27 of 354 · 7,077 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 54181-009-50 54181000950 1 TUBE in 1 BOX (54181-009-50) / 50 mL in 1 TUBE 1 tube 2019-01-01 2027-02-01 No No Current