Home NDC 73054-104 SOLARA SUNCARE - POUT PROTECTOR
Product NDC 73054-104
11-digit product format 730540104
Labeler code 73054
Product ID 73054-104_4690f7ee-2f52-3b32-e063-6394a90a806d
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler SOLARA SUNCARE, INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-06
Substance ZINC OXIDE
Active strength 11 g/100mL
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 SOLARA SUNCARE - POUT PROTECTOR
Brand name suffix SPF-15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 11 g/100mL
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 73054-104-01 SOLARA SUNCARE - POUT PROTECTORSPF-15 10 mL in 1 TUBE CREAM 10 9 73054-104-11 SOLARA SUNCARE - POUT PROTECTORSPF-15 1 in 1 BOX CREAM 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73054-104 SOLARA SUNCARE - POUT PROTECTOR SPF-15 (ZINC OXIDE) CREAM [SOLARA SUNCARE, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240816_ab6a326d-3b93-4122-a9f2-05e8203d31ef.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 73054-104-01 73054010401 10 mL in 1 TUBE 10 ml Historical 73054-104-11 73054010411 1 TUBE in 1 BOX (73054-104-11) / 10 mL in 1 TUBE (73054-104-01) 1 tube 2019-07-06 0000-00-00 No No Current