FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Product NDC
85442-203
11-digit product format
854420203
Labeler code
85442
Product ID
85442-203_45b4599d-eb88-0a14-e063-6394a90a4feb
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Saving Face Skinspa Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-13
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
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
85442-203-15Tinted Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52
85442-203-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85442-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SAVING FACE SKINSPA INC.]1Current NDC, 1 package rows20250515_351d27e3-00d4-8d31-e063-6394a90aaf72.zip
85442-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [SAVING FACE SKINSPA INC.]1Current NDC, 1 package rows20250516_351db99e-262f-b67e-e063-6394a90a3418.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85442-203-15854420203151.5 g in 1 PACKET (85442-203-15) 1.5 g2021-10-13YesNoHistorical
85442-203-508544202035053 g in 1 BOTTLE, PUMP (85442-203-50) 53 g2021-10-13NoNoHistorical