Defend and Balance TInted Mineral Sunscreen SPF 50

Product NDC
84378-104
11-digit product format
843780104
Labeler code
84378
Product ID
84378-104_41367f05-59d9-6736-e063-6394a90a5f17
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen
Dosage form
CREAM
Route
TOPICAL
Labeler
Epicuren Discovery
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
4; 15.5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Defend and Balance TInted Mineral Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE4 g/100g
ZINC OXIDE15.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84378-104-28Defend and Balance TInted Mineral Sunscreen SPF 5028 g in 1 BOTTLE, PUMPCREAM281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84378-104-288437801042828 g in 1 BOTTLE, PUMP (84378-104-28) 28 g2025-10-15NoNoCurrent