ULTRA UV SHADE TINTED MOISTURIZING MINERAL SPF 40- zinc oxide cream

Ultra UV Shade tinted moisturizing mineral SPF 40 by

Drug Labeling and Warnings

Ultra UV Shade tinted moisturizing mineral SPF 40 by is a Otc medication manufactured, distributed, or labeled by Joyce Kelly Enterprises, 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

ULTRA UV SHADE TINTED MOISTURIZING MINERAL SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85632-204(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
CI 77491 (UNII: 1K09F3G675)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIMETHICONE (UNII: 92RU3N3Y1O)
CI 77492 (UNII: EX438O2MRT)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GLYCERIN (UNII: PDC6A3C0OX)
CI 77499 (UNII: XM0M87F357)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICA (UNII: V8A1AW0880)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85632-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/12/2019

Labeler - Joyce Kelly Enterprises (134927790)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85632-204)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85632-204)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85632-204)