Home NDC 72839-114 Coral Isle SPF 50 Mineral Sunscreen
Product NDC 72839-114
11-digit product format 728390114
Labeler code 72839
Product ID 72839-114_4d3e875f-b912-3fb8-e063-6394a90a7bd8
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Derma Care Research Labs, LLC
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72839-114-02 Coral Isle SPF 50 Mineral Sunscreen 57 g in 1 BOTTLE LOTION 57 4 72839-114-06 Coral Isle SPF 50 Mineral Sunscreen 170 g in 1 TUBE LOTION 170 4 72839-114-12 Coral Isle SPF 50 Mineral Sunscreen 57 g in 1 TUBE LOTION 57 4 72839-114-16 Coral Isle SPF 50 Mineral Sunscreen 170 g in 1 BOTTLE LOTION 170 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72839-114 CORAL ISLE SPF 50 MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [DERMA CARE RESEARCH LABS, LLC] 2 Current NDC, 4 package rows 20240103_0aafab44-0481-2a22-e063-6294a90abef2.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 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 72839-114-02 72839011402 57 g in 1 BOTTLE (72839-114-02) 57 g 2024-01-02 No No Current 72839-114-06 72839011406 170 g in 1 TUBE (72839-114-06) 170 g 2024-01-02 No No Current 72839-114-12 72839011412 57 g in 1 TUBE (72839-114-12) 57 g 2024-01-02 No No Current 72839-114-16 72839011416 170 g in 1 BOTTLE (72839-114-16) 170 g 2024-01-02 No No Current