Fortuna Sun Hydrating Sunscreen SPF50 by Veganic SKN Limited

Fortuna Sun Hydrating Sunscreen SPF50 by

Drug Labeling and Warnings

Fortuna Sun Hydrating Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by Veganic SKN Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FORTUNA SUN HYDRATING SUNSCREEN SPF50- fortuna sun hydrating sunscreen spf50 cream 
Veganic SKN Limited

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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FORTUNA SUN HYDRATING SUNSCREEN SPF50 
fortuna sun hydrating sunscreen spf50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83252-032
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
SUNFLOWER OIL (UNII: 3W1JG795YI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
WATER (UNII: 059QF0KO0R)
POLYGLYCEROL POLYRICINOLEIC ACID (UNII: 3C96Y1D5T4)
SODIUM ASCORBATE (UNII: S033EH8359)
CANDELILLA WAX (UNII: WL0328HX19)
ISOSTEARIC ACID (UNII: X33R8U0062)
CORIANDER OIL (UNII: 7626GC95E5)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
.BETA.-THUJAPLICIN (UNII: U5335D6EBI)
HYALURONIC ACID (UNII: S270N0TRQY)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83252-032-00	0.1 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/29/2023

Labeler - Veganic SKN Limited (743536682)

Establishment
Name	Address	ID/FEI	Business Operations
Veganic SKN Limited		743536682	manufacture(83252-032) , label(83252-032)

Revised: 9/2023

Document Id: 06521263-8f1e-9c3a-e063-6294a90a5866

34390-5

Set id: 06521263-8f1d-9c3a-e063-6294a90a5866

Version: 1

Effective Time: 20230927