AUSSIEZINC MINERAL SUNSCREEN VEGAN AND ORGANIC MOZZIE REPELLANT- zinc oxide sunscreen cream

AussieZinc Mineral Sunscreen Vegan and Organic Mozzie Repellant by

Drug Labeling and Warnings

AussieZinc Mineral Sunscreen Vegan and Organic Mozzie Repellant by is a Otc medication manufactured, distributed, or labeled by VEGANIC SKN LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

WARNINGS

For external use only.

Do not use on damaged r broken skin.

When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

See ingredients on label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AUSSIEZINC MINERAL SUNSCREEN VEGAN AND ORGANIC MOZZIE REPELLANT 
zinc oxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83252-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
CANDELILLA WAX (UNII: WL0328HX19)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
XANTHAN GUM (UNII: TTV12P4NEE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
VANILLIN (UNII: CHI530446X)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CITRONELLA OIL (UNII: QYO8Q067D0)
COCONUT ALKANES (UNII: 1E5KJY107T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83252-101-00	0.11 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/30/2024
2	NDC: 83252-101-25	0.1 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/30/2024

Labeler - VEGANIC SKN LIMITED (743536682)

Establishment
Name	Address	ID/FEI	Business Operations
VEGANIC SKN LIMITED		743536682	label(83252-101) , manufacture(83252-101) , pack(83252-101)