WL-AAA-Z-A-525- zinc oxide lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Nanophase Technologies Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
63931-4315-1

WL-AAA-Z-A-525- zinc oxide lotion

Nanophase Technologies Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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WL-AAA-Z-A-525

WL-AAA-Z-A-525

WL-AAA-Z-A-525

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 31-4315

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

129 .6 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ISO DECYL SALICYLATE (UNII: S70 9 7PFP4C)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

PHYSALIS ANGULATA (UNII: W4TKW9 D5GG)

ISO CETETH-10 (UNII: 1K9 2T9 9 19 H)

TRIDECYL SALICYLATE (UNII: AZQ0 8 K38 Z1)

DIMETHYLMETHO XY CHRO MANO L (UNII: XBH432G0 1F)

.ALPHA.-BISABO LO L, ( +) - (UNII: 10 5S6 I733Z)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

DIMETHICO NE/VINYL DIMETHICO NE CRO SSPO LYMER ( SO FT PARTICLE) (UNII: 9 E4CO0 W6 C5)

TRILAURETH-4 PHO SPHATE (UNII: M9 6 W2OLL2V)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

DIMETHICO NO L/PRO PYLSILSESQ UIO XANE/SILICATE CRO SSPO LYMER ( 4 50 0 0 0 0 0 0 MW) (UNII: 9 KB5R9 58 PB)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

MICA (UNII: V8 A1AW0 8 8 0 )

O CTYLDO DECYL NEO PENTANO ATE (UNII: X8 725R8 8 3T)

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 2 ) (UNII: V2W71V8 T0 X)

ALLANTO IN (UNII: 344S277G0 Z)

Product Characteristics

Color

pink

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 39 31-4315-1 150 0 0 0 mL in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

0 3/26 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/26 /20 19

Labeler -

Nanophase T echnologies Corporation (623502044)

Registrant -

Nanophase T echnologies Corporation (623502044)

Nanophase Technologies Corporation

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Nano phase Techno lo gies Co rpo ratio n

0 50 38 30 46

api manufacture(6 39 31-4315)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Nano phase Techno lo gies

Co rpo ra tio n

6 2350 20 44

api manufacture(6 39 31-4315) , manufacture(6 39 31-4315) , pack(6 39 31-

4315)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Amco l Health & Beauty So lutio ns

8 726 8 48 0 3

api manufacture(6 39 31-4315)

Revised: 3/2019

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