SPF 101 Non-Tinted

Product NDC
85415-226
11-digit product format
854150226
Labeler code
85415
Product ID
85415-226_4573edb9-2f58-394e-e063-6394a90a8d82
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
The Acne Lab LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-15
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
SPF 101 Non-Tinted
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
85415-226-15SPF 101 Non-Tinted15 g in 1 PACKETCREAM152
85415-226-50SPF 101 Non-Tinted50 g in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85415-226SPF 101 NON-TINTED (ZINC OXIDE) CREAM [THE ACNE LAB LLC]1Current NDC, 1 package rows20250423_334e32a4-c3a5-e37d-e063-6294a90ad6cf.zip
85415-226SPF 101 NON-TINTED (ZINC OXIDE) CREAM [THE ACNE LAB LLC]1Current NDC, 1 package rows20250423_334bf8ea-2485-84e8-e063-6294a90aefa6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85415-226-158541502261515 g in 1 PACKET (85415-226-15) 15 g2024-07-15YesNoHistorical
85415-226-508541502265050 g in 1 BOTTLE, PUMP (85415-226-50) 50 g2024-07-15NoNoHistorical