Home NDC 85748-001 Skin Medicinals SM Clear Broad Spectrum SPF 50
Product NDC 85748-001
11-digit product format 857480001
Labeler code 85748
Product ID 85748-001_5dc06d3f-345c-9b91-e063-6294a90a99b6
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, OCTINOXATE
Dosage form CREAM
Route TOPICAL
Labeler SKIN MEDICINALS LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-01
Substance ZINC OXIDE; OCTINOXATE
Active strength 90; 75 mg/mL; mg/mL
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 Skin Medicinals SM Clear Broad Spectrum SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 90 mg/mL OCTINOXATE 75 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85748-001-00 Skin Medicinals SM Clear Broad Spectrum SPF 50 58 mL in 1 BOTTLE, PUMP CREAM 58 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 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85748-001-00 85748000100 58 mL in 1 BOTTLE, PUMP (85748-001-00) 58 ml 2025-05-01 No No Current 85748-001-01 85748000101 24 TUBE in 1 CARTON (85748-001-01) / 5 mL in 1 TUBE (85748-001-02) 24 tube 2026-10-01 Yes No Current 85748-001-03 85748000103 1 BOTTLE, PUMP in 1 BOX (85748-001-03) / 50 mL in 1 BOTTLE, PUMP (85748-001-04) 2026-10-01 No No Current