LES DUETS - SHIELD OF HELIOS, SUNSCREEN SPF50- zinc oxide sunscreen cream

Les Duets - Shield of Helios, sunscreen SPF50 by

Drug Labeling and Warnings

Les Duets - Shield of Helios, sunscreen 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

kindly refer to label picture

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

Kindly refer to Label

INACTIVE INGREDIENT

See ingredients on label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LES DUETS - SHIELD OF HELIOS, SUNSCREEN SPF50 
zinc oxide sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83252-111
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
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
SODIUM ASCORBATE (UNII: S033EH8359)
XANTHAN GUM (UNII: TTV12P4NEE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISABOLOL (UNII: 24WE03BX2T)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CORIANDER OIL (UNII: 7626GC95E5)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
CITRUS PARADISI (GRAPEFRUIT) SEED OIL (UNII: 598D944HOL)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
JOJOBA OIL (UNII: 724GKU717M)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
CANDELILLA WAX (UNII: WL0328HX19)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83252-111-01	0.07 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/14/2025

Labeler - VEGANIC SKN LIMITED (743536682)

Establishment
Name	Address	ID/FEI	Business Operations
VEGANIC SKN LIMITED		743536682	manufacture(83252-111) , label(83252-111) , pack(83252-111)