PRIME AND PROTECT MATTE- titanium dioxide, zinc oxide cream

Prime And Protect Matte by

Drug Labeling and Warnings

Prime And Protect Matte by is a Otc medication manufactured, distributed, or labeled by Kalon Skin Studio, LLC, Fragrance Manufacturing INC, Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

WARNINGS

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

OTHER SAFETY INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRIME AND PROTECT MATTE 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85363-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	38 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
ALUMINA (UNII: LMI26O6933)
CI 77492 (UNII: EX438O2MRT)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77491 (UNII: 1K09F3G675)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CI 77499 (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85363-203-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/25/2023

Labeler - Kalon Skin Studio, LLC (118331568)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85363-203)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85363-203)