AUSSIEZINC MINERAL SUNSCREEN SPF50 BABY- zinc oxide cream

Aussiezinc Mineral Sunscreen SPF50 Baby by

Drug Labeling and Warnings

Aussiezinc Mineral Sunscreen SPF50 Baby by is a Otc medication manufactured, distributed, or labeled by Veganic SKN Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: Zinc oxide 25% w/w

PURPOSE

Purpose: sunscreen

INDICATIONS & USAGE

Please kindly refer to label

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

Please kindly refer to label.

INACTIVE INGREDIENT

Please kindly refer to label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AUSSIEZINC MINERAL SUNSCREEN SPF50 BABY 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83252-056
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
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CANDELILLA WAX (UNII: WL0328HX19)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
XANTHAN GUM (UNII: TTV12P4NEE)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCONUT ALKANES (UNII: 1E5KJY107T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83252-056-00	0.11 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/23/2024
2	NDC: 83252-056-25	0.1 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/24/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/23/2024

Labeler - Veganic SKN Limited (743536682)

Establishment
Name	Address	ID/FEI	Business Operations
Veganic SKN Limited		743536682	manufacture(83252-056) , pack(83252-056) , label(83252-056)