ELLEGREEN SUNSCREEN BROAD SPECTRUM SPF50- zinc oxide cream

Ellegreen Sunscreen Broad Spectrum SPF50 by

Drug Labeling and Warnings

Ellegreen Sunscreen Broad Spectrum SPF50 by is a Otc medication manufactured, distributed, or labeled by Veganic SKN Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc oxide 25%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Please kindly refer to artwork

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 artwork

INACTIVE INGREDIENT

Please kindly refer to artwork

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELLEGREEN SUNSCREEN BROAD SPECTRUM SPF50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83252-055
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
CITRUS PARADISI SEED (UNII: 12F08874Y7)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
JOJOBA OIL (UNII: 724GKU717M)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CANDELILLA WAX (UNII: WL0328HX19)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERIN (UNII: PDC6A3C0OX)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ASCORBATE (UNII: S033EH8359)
CORIANDER OIL (UNII: 7626GC95E5)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83252-055-00	0.11 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/15/2024

Labeler - Veganic SKN Limited (743536682)

Establishment
Name	Address	ID/FEI	Business Operations
Veganic SKN Limited		743536682	manufacture(83252-055) , pack(83252-055) , label(83252-055)