Home NDC 84203-002 Leg and Body Makeup Broad Spectrum SPF 25
Product NDC 84203-002
11-digit product format 842030002
Labeler code 84203
Product ID 84203-002_3aaeeafe-b737-c1e4-e063-6394a90af100
Type HUMAN OTC DRUG
Nonproprietary name Octisalate 3.2% Octocrylene 6%
Dosage form LIQUID
Route TOPICAL
Labeler Baxter of California, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-27
Substance OCTISALATE; OCTOCRYLENE
Active strength 32; 60 mg/mL; mg/mL
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 Leg and Body Makeup Broad Spectrum SPF 25
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 32 mg/mL OCTOCRYLENE 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup 5A68WGF6WM 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 84203-002-01 Leg and Body Makeup Broad Spectrum SPF 25 1 in 1 CARTON LIQUID 1 3 84203-002-01 Leg and Body Makeup Broad Spectrum SPF 25 100 mL in 1 TUBE LIQUID 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84203-002 LEG AND BODY MAKEUP BROAD SPECTRUM SPF 25 (OCTISALATE 3.2% OCTOCRYLENE 6%) LIQUID [BAXTER OF CALIFORNIA, LLC] 2 Current NDC, 2 package rows 20240620_14adc826-6e9d-382a-e063-6294a90a5d79.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 84203-002-01 84203000201 1 TUBE in 1 CARTON (84203-002-01) / 100 mL in 1 TUBE 1 tube 2024-03-27 No No Current