Home NDC 83735-002 P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum
Product NDC 83735-002
11-digit product format 837350002
Labeler code 83735
Product ID 83735-002_44ea9fb4-8e02-6969-e063-6294a90a6a94
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octisalate, Octocrylene, Avobenzone
Dosage form LOTION
Route TOPICAL
Labeler LIFE WITHCORPORATION Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-01
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE
Active strength 2.7; 4.5; 9; 13.5 g/100mL; g/100mL; g/100mL; 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 P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.7 g/100mL OCTISALATE 4.5 g/100mL OCTOCRYLENE 9 g/100mL HOMOSALATE 13.5 g/100mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83735-002-01 P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum 50 mL in 1 TUBE LOTION 50 1 83735-002-02 P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum 1 in 1 BOX LOTION 1 1
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 83735-002-01 83735000201 50 mL in 1 TUBE 50 ml Historical 83735-002-02 83735000202 1 TUBE in 1 BOX (83735-002-02) / 50 mL in 1 TUBE (83735-002-01) 1 tube 2026-02-01 No No Current