Eezy Pro SPF50

Product NDC
70116-009
11-digit product format
701160009
Labeler code
70116
Product ID
70116-009_a52e7e5b-20c1-40ce-be78-11b2d3b7c8b0
Type
HUMAN OTC DRUG
Nonproprietary name
Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
BIO EARTH MANUFACTURING (PTY) LTD
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-17
Marketing end
0000-00-00
Substance
MERADIMATE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70116-009IInactivated by FDA2026-10-12
excluded packagepackage70116-00970116-009-01IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
70116-009-01Eezy Pro SPF508 mL in 1 POUCHCREAM84
70116-009-01Eezy Pro SPF5010 in 1 PACKETCREAM104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70116-009EEZY PRO SPF50 (MERADIMATE, OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIO EARTH MANUFACTURING (PTY) LTD]4Legacy NDC, 2 package rows20241101_b4c4a21e-e01c-4c5a-b5b0-210594298fb1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70116-009-017011600090110 POUCH in 1 PACKET (70116-009-01) > 8 mL in 1 POUCH10 pouch2020-03-170000-00-00NoNoCurrent