Home NDC 71221-792 Coral Safe SPF-30 Broad Spectrum Sunscreen
Product NDC 71221-792
11-digit product format 712210792
Labeler code 71221
Product ID 71221-792_09d8c273-4504-2a49-e063-6394a90a3a09
Type HUMAN OTC DRUG
Nonproprietary name TITANIUM DIOXIDE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Elements Brands, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-02-21
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 60; 60 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Coral Safe SPF-30 Broad Spectrum Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 60 mg/mL ZINC OXIDE 60 mg/mL
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 71221-792-08 Coral Safe SPF-30 Broad Spectrum Sunscreen 236 mL in 1 BOTTLE CREAM 236 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71221-792 CORAL SAFE SPF-30 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231111_4925a3ad-6379-108a-e054-00144ff8d46c.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 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 71221-792-08 71221079208 236 mL in 1 BOTTLE (71221-792-08) 236 ml 2017-02-21 0000-00-00 No No Current