ULTRA ZINC MINERAL NON TINTED- zinc oxide cream

Ultra Zinc Mineral Non Tinted by

Drug Labeling and Warnings

Ultra Zinc Mineral Non Tinted by is a Otc medication manufactured, distributed, or labeled by Skin Therapy Studio 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

ULTRA ZINC MINERAL NON TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85357-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85357-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/13/2024

Labeler - Skin Therapy Studio LLC  (113674755)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85357-205)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85357-205)