FDA.reportPublic FDA data

Satin Tint

Product NDC
85334-208
11-digit product format
853340208
Labeler code
85334
Product ID
85334-208_45c8c870-2b5b-4fe6-e063-6294a90a5113
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Brent Loftis, D.O., Inc., A California Medical Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-19
Substance
ZINC OXIDE
Active strength
160 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
Satin Tint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85334-208-15Satin Tint1.5 g in 1 PACKETCREAM1.52
85334-208-50Satin Tint50 g in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85334-208SATIN TINT (ZINC OXIDE) CREAM [BRENT LOFTIS, D.O., INC., A CALIFORNIA MEDICAL CORPORATION]1Current NDC, 1 package rows20250522_35920108-7f8a-27d4-e063-6294a90a0ef6.zip
85334-208SATIN TINT (ZINC OXIDE) CREAM [BRENT LOFTIS, D.O., INC., A CALIFORNIA MEDICAL CORPORATION]1Current NDC, 1 package rows20250523_359684cf-ca11-f9af-e063-6394a90ac4c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85334-208-15853340208151.5 g in 1 PACKET (85334-208-15) 1.5 g2024-04-19YesNoCurrent
85334-208-508533402085050 g in 1 BOTTLE, PUMP (85334-208-50) 50 g2024-04-19NoNoCurrent