DEFEND AND BALANCE TINTED MINERAL SUNSCREEN SPF 50- sunscreen cream

Defend and Balance TInted Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

Defend and Balance TInted Mineral Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Epicuren Discovery. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

KEEP OUT OF REACH OF CHILDREN

WARNINGS

PURPOSE

INDICATIONS & USAGE

OTHER SAFETY INFORMATION

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEFEND AND BALANCE TINTED MINERAL SUNSCREEN SPF 50 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84378-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAURYL METHICONE (UNII: 5OHO78HI1D)
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL (UNII: 412ZHA4T4Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE (UNII: 92RU3N3Y1O)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL (UNII: 8U3877WD44)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84378-104-28	28 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/15/2025

Labeler - Epicuren Discovery (801018029)