AcneFix Non-Tinted Mineral Sunscreen

Product NDC
85396-202
11-digit product format
853960202
Labeler code
85396
Product ID
85396-202_45762cb3-1b09-82f6-e063-6294a90ab9c2
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ACNEFIX INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-16
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
AcneFix Non-Tinted Mineral Sunscreen
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
85396-202-50AcneFix Non-Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85396-202ACNEFIX NON-TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ACNEFIX INC.]1Current NDC, 1 package rows20250330_31583c7e-365a-d899-e063-6394a90aa63f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85396-202-508539602025053 g in 1 BOTTLE, PUMP (85396-202-50) 53 g2022-11-16NoNoCurrent