Home NDC 76458-401 Circadia Circa-Shield Mineral Sunscreen SPF 30
Product NDC 76458-401
11-digit product format 764580401
Labeler code 76458
Product ID 76458-401_0d1ad873-78fa-d26e-e063-6294a90a3712
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Circadia by Dr Pugliese, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-31
Substance ZINC OXIDE
Active strength 173 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 Circadia Circa-Shield Mineral Sunscreen SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 173 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 76458-401-00 Circadia Circa-Shield Mineral Sunscreen SPF 30 59 mL in 1 TUBE CREAM 59 2 76458-401-00 Circadia Circa-Shield Mineral Sunscreen SPF 30 1 in 1 BOX CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76458-401 CIRCADIA CIRCA-SHIELD MINERAL SUNSCREEN SPF 30 (ZINC OXIDE) CREAM [CIRCADIA BY DR PUGLIESE, INC.] 2 Current NDC, 2 package rows 20231231_2959aa56-be7f-4721-9701-e6d6e12cc850.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 Sample Exclude flag Status 76458-401-00 76458040100 1 TUBE in 1 BOX (76458-401-00) / 59 mL in 1 TUBE 1 tube 2023-12-31 No No Current