SMOOTHING MINERAL SUNSCREEN TINTED- titanium dioxide, zinc oxide cream

Smoothing Mineral Sunscreen Tinted by

Drug Labeling and Warnings

Smoothing Mineral Sunscreen Tinted by is a Otc medication manufactured, distributed, or labeled by DANIEL BEHROOZAN MD A MEDICAL CORPORATION, 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

SMOOTHING MINERAL SUNSCREEN TINTED 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85328-203
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

Inactive Ingredients
Ingredient Name	Strength
ALUMINA (UNII: LMI26O6933)
CI 77499 (UNII: XM0M87F357)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CI 77491 (UNII: 1K09F3G675)
ZINC OXIDE (UNII: SOI2LOH54Z)	38 mg  in 1 g
CI 77492 (UNII: EX438O2MRT)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85328-203-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/24/2019

Labeler - DANIEL BEHROOZAN MD A MEDICAL CORPORATION (130841337)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85328-203)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85328-203)