FDA.reportPublic FDA data

Defend and Balance TInted Mineral Sunscreen SPF 50

Manufacturer
Epicuren Discovery
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:39:19

Label at a glance#

ProductDefend and Balance TInted Mineral Sunscreen SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of ChildrenKeep out of reach of Children

WARNINGS SECTION

WarningsWarnings

OTC - PURPOSE SECTION

PurposePurpose

INDICATIONS & USAGE SECTION

Indication and UsesIndication and Uses

OTHER SAFETY INFORMATION

Other InformationOther Information

DOSAGE & ADMINISTRATION SECTION

Dosage and AdminDosage and Admin

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront Label

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84378-10484378-104-28

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURYL METHICONE5OHO78HI1DIACT
ALEURITES MOLUCCANA SEEDJ87WJ3E7VWIACT
SODIUM CHLORIDE451W47IQ8XIACT
FERRIC OXIDE RED1K09F3G675IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPANEDIOL5965N8W85TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL412ZHA4T4YIACT
ETHYLHEXYL PALMITATE2865993309IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
DIMETHICONE92RU3N3Y1OIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL8U3877WD44IACT
ARGANIA SPINOSA KERNEL OIL4V59G5UW9XIACT
ZINC OXIDESOI2LOH54ZACTIB
CUCUMIS SATIVUS LEAFQ6S42514LPIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
SODIUM HYALURONATEYSE9PPT4THIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
ndc (package): 84378-104-28
ndc (product): 84378-104
ndc11 (package): 84378010428
spl id: 41367f05-59d9-6736-e063-6394a90a5f17
spl set id: 41367f05-59d8-6736-e063-6394a90a5f17

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.