PROTECT 20 ZINC OXIDE MINERAL SUNSCREEN TINTED- zinc oxide cream

Protect 20 Zinc Oxide Mineral Sunscreen Tinted by

Drug Labeling and Warnings

Protect 20 Zinc Oxide Mineral Sunscreen Tinted by is a Otc medication manufactured, distributed, or labeled by Melinda Menezes, M.D., Inc., Fragrance Manufacturing Inc, Custom Analytics LLC. 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

PROTECT 20 ZINC OXIDE MINERAL SUNSCREEN TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85314-204
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 (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CI 77492 (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CI 77499 (UNII: XM0M87F357)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
WATER (UNII: 059QF0KO0R)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77491 (UNII: 1K09F3G675)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85314-204-60	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/18/2018

Labeler - Melinda Menezes, M.D., Inc. (022910406)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc		793406000	manufacture(85314-204)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85314-204)