REJUVN8

Product NDC
85635-203
11-digit product format
856350203
Labeler code
85635
Product ID
85635-203_46028bf9-854d-2b10-e063-6394a90a5735
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
FLEUR DE VIE LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-11
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
REJUVN8
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85635-203-15REJUVN815 g in 1 PACKETCREAM152
85635-203-50REJUVN853 g in 1 BOTTLE, PUMPCREAM532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85635-203-158563502031515 g in 1 PACKET (85635-203-15) 15 g2020-08-03YesNoCurrent
85635-203-508563502035053 g in 1 BOTTLE, PUMP (85635-203-50) 53 g2019-11-11NoNoCurrent