AUSET TINTED REPLENISHING DAILY PROTECTION- zinc oxide cream

Auset Tinted Replenishing Daily Protection by

Drug Labeling and Warnings

Auset Tinted Replenishing Daily Protection by is a Otc medication manufactured, distributed, or labeled by SHAYLA BOGER SKIN THERAPY 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

AUSET TINTED REPLENISHING DAILY PROTECTION 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85725-208
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
CERAMIDE 3 (UNII: 4370DF050B)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77499 (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
CI 77492 (UNII: EX438O2MRT)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77491 (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85725-208-50	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/30/2023

Labeler - SHAYLA BOGER SKIN THERAPY LLC (108854995)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85725-208)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85725-208)