Home NDC 87700-539 Societe Prime and Defend
Product NDC 87700-539
11-digit product format 877000539
Labeler code 87700
Product ID 87700-539_546202e1-9cd6-c5ff-e063-6394a90a7229
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide Sunscreen
Dosage form CREAM
Route TOPICAL
Labeler Societe Clinical Skincare
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-01
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 10; 4 g/100g; g/100g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Societe Prime and Defend
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 10 g/100g ZINC OXIDE 4 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 87700-539-01 87700053901 57 g in 1 TUBE (87700-539-01) 57 g 2024-11-01 No No Current