PROJECT REEF SPF-50

Product NDC
81637-179
11-digit product format
816370179
Labeler code
81637
Product ID
81637-179_0976cb4f-2ad9-fc33-e063-6394a90a11c7
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Project Reef LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-05
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 140 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

Additional Listing Data#

Finished product
Yes
Brand name base
PROJECT REEF SPF-50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE140 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81637-179-00PROJECT REEF SPF-50125 mL in 1 TUBECREAM1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81637-179PROJECT REEF SPF-50 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [PROJECT REEF LLC]2Current NDC, Legacy NDC, 1 package rows20231106_6bcd470c-6994-4d28-8370-4cc9d68e1e78.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81637-179-0081637017900125 mL in 1 TUBE (81637-179-00) 125 ml2021-04-050000-00-00NoNoCurrent