FDA.reportPublic FDA data

MAXIMUM REPAIR SPF 50

Product NDC
84178-008
11-digit product format
841780008
Labeler code
84178
Product ID
84178-008_47e23e72-d1f3-b33f-e063-6294a90ae39c
Type
HUMAN OTC DRUG
Nonproprietary name
SPF 50
Dosage form
CREAM
Route
CUTANEOUS
Labeler
EVI LABS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-09
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
Active strength
1.44; 4.8; 2.88; 2.4 g/48g; g/48g; g/48g; g/48g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MAXIMUM REPAIR SPF 50
Brand name suffix
Broad Spectrum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.44 g/48g
HOMOSALATE4.8 g/48g
OCTINOXATE2.88 g/48g
OCTISALATE2.4 g/48g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84178-008-01MAXIMUM REPAIR SPF 50Broad Spectrum1 in 1 BOXCREAM12
84178-008-01MAXIMUM REPAIR SPF 50Broad Spectrum48 g in 1 BOTTLE, PUMPCREAM482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84178-008MAXIMUM REPAIR SPF 50 BROAD SPECTRUM (SPF 50) CREAM [EVI LABS]1Current NDC, 2 package rows20241017_240d46ab-3993-9c5a-e063-6394a90ad800.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84178-008-01841780008011 BOTTLE, PUMP in 1 BOX (84178-008-01) / 48 g in 1 BOTTLE, PUMP2024-10-09NoNoCurrent