MINERAL SUNSCREEN 20PERCENT ZINC OXIDE- zinc oxide cream

Mineral Sunscreen 20percent Zinc Oxide by

Drug Labeling and Warnings

Mineral Sunscreen 20percent Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by MANTRA WELLNESS SPA, 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

MINERAL SUNSCREEN 20PERCENT ZINC OXIDE 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85377-205(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
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE (UNII: 92RU3N3Y1O)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
WATER (UNII: 059QF0KO0R)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85377-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/31/2023

Labeler - MANTRA WELLNESS SPA (119470242)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85377-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(85377-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85377-205)