SEYTU Body Sunscreen

Product NDC
84271-001
11-digit product format
842710001
Labeler code
84271
Product ID
84271-001_1959d76a-87e7-4cdd-9f18-40635e23e2a7
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
8.3; 4.875 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 Body Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE8.3 g/100mL
ZINC OXIDE4.875 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84271-001-01SEYTU Body Sunscreen1 in 1 BOXCREAM12
84271-001-01SEYTU Body Sunscreen120 mL in 1 TUBECREAM1202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84271-001-01842710001011 TUBE in 1 BOX (84271-001-01) / 120 mL in 1 TUBE1 tube2024-04-15NoNoHistorical