GENTLE MINERAL SPF 40 TINTED- zinc oxide cream

Gentle Mineral SPF 40 Tinted by

Drug Labeling and Warnings

Gentle Mineral SPF 40 Tinted by is a Otc medication manufactured, distributed, or labeled by ELIZA ARAKELIAN, Custom Analytics LLC, Fragrance Manufacturing Inc, Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

WARNINGS

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

OTHER SAFETY INFORMATION

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENTLE MINERAL SPF 40 TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85555-204(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
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
GLYCERIN (UNII: PDC6A3C0OX)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CI 77491 (UNII: 1K09F3G675)
CI 77492 (UNII: EX438O2MRT)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CI 77499 (UNII: XM0M87F357)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85555-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/22/2019

Labeler - ELIZA ARAKELIAN (125207466)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85555-204)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85555-204)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85555-204)