Home NDC 49757-114 Coral Isle SPF 50 Mineral Sunscreen
Product NDC 49757-114
11-digit product format 497570114
Labeler code 49757
Product ID 49757-114_5515f562-62da-c6ee-e063-6294a90a9ea6
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Rocky Mountain
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-23
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 4.5; 4 g/100g; g/100g
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 Coral Isle SPF 50 Mineral Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 4.5 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 49757-114-02 49757011402 57 g in 1 BOTTLE (49757-114-02) 57 g 2024-01-02 No No Current 49757-114-06 49757011406 170 g in 1 BOTTLE (49757-114-06) 170 g 2024-01-02 No No Current