HYDRATING MINERAL ZINC OXIDE SPF 40- zinc oxide cream

Hydrating Mineral Zinc Oxide SPF 40 by

Drug Labeling and Warnings

Hydrating Mineral Zinc Oxide SPF 40 by is a Otc medication manufactured, distributed, or labeled by Spalina LLC., 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

HYDRATING MINERAL ZINC OXIDE SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85360-205
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
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85360-205-04	113 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/08/2019

Labeler - Spalina LLC. (105212651)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85360-205)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85360-205)