Home NDC 84938-007 Sunscreen Cream
Product NDC 84938-007
11-digit product format 849380007
Labeler code 84938
Product ID 84938-007_460f0ca0-9441-9a6e-e063-6394a90a33b3
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide 12%,Titanium Dioxide 8%, Homosalate 12%, Octisalate4.5%,Phenylbenzimidazole Sulfonic Acid 3.5%
Dosage form CREAM
Route TOPICAL
Labeler Foshan Sugar Max Cosmetics CO.,Ltd
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-16
Substance PHENYLBENZIMIDAZOLE SULFONIC ACID; ZINC OXIDE; TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE
Active strength .035; .12; .08; .12; .045 g/mL; g/mL; g/mL; g/mL; g/mL
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 Sunscreen Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLBENZIMIDAZOLE SULFONIC ACID .035 g/mL ZINC OXIDE .12 g/mL TITANIUM DIOXIDE .08 g/mL HOMOSALATE .12 g/mL OCTISALATE .045 g/mL
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 84938-007-01 Sunscreen Cream 90 mL in 1 BOTTLE CREAM 90 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 84938-007-01 84938000701 90 mL in 1 BOTTLE (84938-007-01) 90 ml 2025-12-16 No No Current