Home NDC 73691-047 OUTER REEF MINERAL SUNSCREEN SPF 30
Product NDC 73691-047
11-digit product format 736910047
Labeler code 73691
Product ID 73691-047_48c0bc5e-03f5-d430-e063-6394a90aac6b
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE
Dosage form CREAM
Route TOPICAL
Labeler Coral Reef Park Co., Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-10
Substance TITANIUM DIOXIDE
Active strength 80 mg/mL
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 OUTER REEF MINERAL SUNSCREEN SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 80 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup
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 73691-047-00 OUTER REEF MINERAL SUNSCREEN SPF 30 100 mL in 1 TUBE CREAM 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73691-047 OUTER REEF MINERAL SUNSCREEN SPF 30 (TITANIUM DIOXIDE) CREAM [CORAL REEF PARK CO., INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231106_86ee2fdf-8a88-44e6-b12a-36a92360477a.zip
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 Marketing end Sample Exclude flag Status 73691-047-00 73691004700 100 mL in 1 TUBE (73691-047-00) 100 ml 2020-03-10 0000-00-00 No No Current