Original Tint

Product NDC
85768-203
11-digit product format
857680203
Labeler code
85768
Product ID
85768-203_4586e755-54a8-4970-e063-6294a90aa01c
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
L.S. MOORE LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-20
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
Original Tint
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
85768-203-15Original Tint1.5 g in 1 PACKETCREAM1.52
85768-203-50Original Tint53 g in 1 BOTTLE, PUMPCREAM532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85768-203-15857680203151.5 g in 1 PACKET (85768-203-15) 1.5 g2024-07-16YesNoCurrent
85768-203-508576802035053 g in 1 BOTTLE, PUMP (85768-203-50) 53 g2024-12-20NoNoCurrent