ZINC 20 MINERAL SUNSCREEN FACE PLUS BODY- zinc oxide cream

Zinc 20 mineral sunscreen face Plus body by

Drug Labeling and Warnings

Zinc 20 mineral sunscreen face Plus body by is a Otc medication manufactured, distributed, or labeled by PURE VITALITY SKIN AND BODY, INC, 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

ZINC 20 MINERAL SUNSCREEN FACE PLUS BODY 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85367-205(NDC:58892-205)
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
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85367-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/05/2022

Labeler - PURE VITALITY SKIN AND BODY, INC (029894266)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85367-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85367-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85367-205)