TINTED MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

Tinted Mineral Sunscreen by

Drug Labeling and Warnings

Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Maloney Plastic Surgery Skin Care, PLLC, 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

TINTED MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85318-203
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85318-203-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/27/2021

Labeler - Maloney Plastic Surgery Skin Care, PLLC (080719997)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85318-203)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85318-203)