X-TREME CREAM PROPOLIS SUNSCREEN SPF 45- x-treme cream cream

X-Treme Cream Propolis Sunscreen SPF 45 by

Drug Labeling and Warnings

X-Treme Cream Propolis Sunscreen SPF 45 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

PURPOSE

INDICATIONS & USAGE

OTHER SAFETY INFORMATION

WARNINGS

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

X-TREME CREAM PROPOLIS SUNSCREEN SPF 45 
x-treme cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84378-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
METHYLCELLULOSE (UNII: Z944H5SN0H)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ALLANTOIN (UNII: 344S277G0Z)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84378-101-74	74 g in 1 TUBE; Type 0: Not a Combination Product	08/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/30/2025

Labeler - Epicuren Discovery (801018029)