PROJECT REEF Mineral Sunscreen SPF-50

Product NDC
81637-299
11-digit product format
816370299
Labeler code
81637
Product ID
81637-299_09e285b2-b615-08b4-e063-6394a90a8964
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, TITANIUM DIOXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Project Reef LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-21
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 Mineral Sunscreen 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
81637-299-00PROJECT REEF Mineral Sunscreen SPF-50946.35 mL in 1 BOTTLELOTION946.352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81637-299PROJECT REEF MINERAL SUNSCREEN SPF-50 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [PROJECT REEF LLC]2Current NDC, Legacy NDC, 1 package rows20231112_87b9170c-956e-4aa2-9416-da00cca81b58.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81637-299-0081637029900946.35 mL in 1 BOTTLE (81637-299-00) 946.35 ml2022-03-210000-00-00NoNoCurrent