TINTED FACIAL SUNSCREEN- titanium dioxide, zinc oxide cream

Tinted Facial Sunscreen by

Drug Labeling and Warnings

Tinted Facial Sunscreen by is a Otc medication manufactured, distributed, or labeled by HELTON SKIN & LASER INSTITUTE, Custom Analytics LLC, Fragrance Manufacturing Inc., Fallien Cosmeceuticals Ltd.. 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 FACIAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85679-203(NDC:58892-203)
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
ALUMINA (UNII: LMI26O6933)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85679-203-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/24/2019

Labeler - HELTON SKIN & LASER INSTITUTE (043023268)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85679-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85679-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85679-203)