20 ZINC OXIDE TINTED MINERAL SUNSCREEN- zinc oxide cream

20 Zinc Oxide Tinted Mineral Sunscreen by

Drug Labeling and Warnings

20 Zinc Oxide Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by AGELESS SKINCARE 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

20 ZINC OXIDE TINTED MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85621-204(NDC:58892-204)
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
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
MICA (UNII: V8A1AW0880)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CI 77499 (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85621-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/07/2020

Labeler - AGELESS SKINCARE INC (130050010)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85621-204)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85621-204)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85621-204)