BARE SKIN SMOOTH MINERAL TINT- zinc oxide cream

bare skin smooth mineral tint by

Drug Labeling and Warnings

bare skin smooth mineral tint by is a Otc medication manufactured, distributed, or labeled by Skin & Bare It 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

BARE SKIN SMOOTH MINERAL TINT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85425-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77491 (UNII: 1K09F3G675)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CI 77492 (UNII: EX438O2MRT)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CERAMIDE 3 (UNII: 4370DF050B)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77499 (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85425-208-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/29/2020

Labeler - Skin & Bare It LLC (115072286)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85425-208)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85425-208)