Home NDC 69435-1412 FRE PROTECT BODY Ultra-Light Gel Cream SPF 50
Product NDC 69435-1412
11-digit product format 694351412
Labeler code 69435
Product ID 69435-1412_2ce7cd35-c5f0-c731-e063-6294a90a19c8
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form JELLY
Route TOPICAL
Labeler Peer Pharm Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-14
Substance ZINC OXIDE
Active strength 24 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 FRE PROTECT BODY Ultra-Light Gel Cream SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 24 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
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 69435-1412-1 FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 100 mL in 1 BOTTLE, PUMP JELLY 100 2 69435-1412-1 FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 1 in 1 CARTON JELLY 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69435-1412 FRE PROTECT BODY ULTRA-LIGHT GEL CREAM SPF 50 (ZINC OXIDE) JELLY [PEER PHARM LTD.] 2 Current NDC, 2 package rows 20250131_2cd83c55-851c-089e-e063-6294a90ad6bc.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 Marketing start Sample Exclude flag Status 69435-1412-1 69435141201 1 BOTTLE, PUMP in 1 CARTON (69435-1412-1) / 100 mL in 1 BOTTLE, PUMP 2025-01-14 No No Current