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 Skin & Bare It LLC, 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 MINERAL SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85425-203(NDC:58892-203)
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
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINA (UNII: LMI26O6933)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85425-203-50	53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/30/2019

Labeler - Skin & Bare It LLC (115072286)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85425-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85425-203)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85425-203)