Home NDC 75470-303 SUNBEAT PROCARE FPS 50 KIDS
Product NDC 75470-303
11-digit product format 754700303
Labeler code 75470
Product ID 75470-303_42c8df26-6c81-eab3-e063-6294a90a1d23
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLE
Dosage form LOTION
Route TOPICAL
Labeler Tecnoglobal, PH7 S.A. DE C.V.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-11-01
Substance ENSULIZOLE; HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength 2; 14; 5; 3; 9 mg/60mg; mg/60mg; mg/60mg; mg/60mg; mg/60mg
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 SUNBEAT PROCARE FPS 50 KIDS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENSULIZOLE 2 mg/60mg HOMOSALATE 14 mg/60mg OCTISALATE 5 mg/60mg AVOBENZONE 3 mg/60mg OCTOCRYLENE 9 mg/60mg
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75470-303-01 SUNBEAT PROCARE FPS 50 KIDS 60 mg in 1 TUBE LOTION 60 3
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 75470-303-01 75470030301 60 mg in 1 TUBE (75470-303-01) 60 mg 2025-11-01 No No Current