Home NDC 85053-007 BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN
Product NDC 85053-007
11-digit product format 850530007
Labeler code 85053
Product ID 85053-007_54fc80b7-8f6d-e2be-e063-6394a90a4b59
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE
Dosage form CREAM
Route TOPICAL
Labeler Shantou Woodsleep Biotechnology Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-24
Substance PHENYLBENZIMIDAZOLE SULFONIC ACID; AVOBENZONE; TITANIUM DIOXIDE; OCTOCRYLENE
Active strength 1; .75; 4.5; 1 mg/50mg; mg/50mg; mg/50mg; mg/50mg
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 BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLBENZIMIDAZOLE SULFONIC ACID 1 mg/50mg AVOBENZONE .75 mg/50mg TITANIUM DIOXIDE 4.5 mg/50mg OCTOCRYLENE 1 mg/50mg
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.
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 45 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 85053-007-01 85053000701 50 mg in 1 BOX (85053-007-01) 50 mg 2026-06-24 No No Current