SEYTU Facial Sunscreen

Product NDC
84271-000
11-digit product format
842710000
Labeler code
84271
Product ID
84271-000_3d2ac1ee-ae05-4012-84e1-58ed9d287e83
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide and zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Omnilife USA, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
5.81; 3.9 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SEYTU Facial Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE5.81 g/100mL
ZINC OXIDE3.9 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84271-000-00SEYTU Facial Sunscreen40 mL in 1 TUBECREAM402
84271-000-00SEYTU Facial Sunscreen1 in 1 BOXCREAM12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84271-000-00842710000001 TUBE in 1 BOX (84271-000-00) / 40 mL in 1 TUBE1 tube2024-04-15NoNoHistorical