SNOWBERRY- zinc oxide cream
Snowberry New Zealand Ltd

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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Drug Facts

Ingredients Agua (Demineralised), Sorbitan Olivate (Olive),

Cetyl Palmitate, Sorbitan Palmitate, Coco Glucoside, Cetrary Alcohol (wheat extract), Glycerin (Coconut),

Coffea Arabica (Coffee Bean) oil, Butyrosperum parkii (shea Butter), Inga edulis (Inga) seed extract,

Brassica Campestris (Rapeseed) oil, Stearic Acid, Glycerin, Glycin Soja (soybean oil), Glucose,

Glucose Oxidase, Lactoperoxidase, Porphyraumbilicasis (Seaweed) extract,

Cassia Alata leaf extract, Aloe barbadensis leaf extract, Guar Gum,

Tocopherol (mixed), Beta-Sitosterol, Squalene (sunflower), Sclerotium Gum

Active Ingredients Zinc oxide, Caprylic Capric triglycerides,

Kaempferia Galanga Root extract, Ethyl Fenulate, Larix Sabirica (Siberian larch) extract

Avoid contact with eyes

copy of label

SNOWBERRY
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58231-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.6 g in 10 g
KAEMPFERIA GALANGA ROOT (UNII: 7B7U9D12AI) (KAEMPFERIA GALANGA ROOT - UNII:7B7U9D12AI)	KAEMPFERIA GALANGA ROOT	0.7 g in 10 g
ETHYL FERULATE (UNII: 5B8915UELW) (ETHYL FERULATE - UNII:5B8915UELW)	ETHYL FERULATE	0.7 g in 10 g
LARIX SIBIRICA WOOD (UNII: KSC3PGF73L) (LARIX SIBIRICA WOOD - UNII:KSC3PGF73L)	LARIX SIBIRICA WOOD	0.3 g in 10 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERIN (UNII: PDC6A3C0OX)
ARABICA COFFEE OIL (UNII: IK55HKE887)
SHEA BUTTER (UNII: K49155WL9Y)
INGA EDULIS SEED (UNII: GC3TZ3X7A4)
BRASSICA RAPA VAR. RAPA (UNII: AIV6895O8B)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
SENNA ALATA WHOLE (UNII: G8NM9MK16J)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
GUAR GUM (UNII: E89I1637KE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58231-001-01	1 in 1 CARTON	04/01/2013	12/31/2013
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2013	12/31/2013

Labeler - Snowberry New Zealand Ltd (594018264)

Revised: 2/2019

Document Id: 812bb226-36cd-2bc2-e053-2a91aa0a2423

Set id: cb947c9e-9147-4c83-8a64-5f3d1791c8c7

Version: 2

Effective Time: 20190205

Snowberry New Zealand Ltd