Fitcover Hydrating Tinted Sunscreen SPF50

Fitcover Hydrating Tinted Sunscreen SPF50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

FITCOVER HYDRATING TINTED SUNSCREEN SPF50- zinc oxide 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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Fitcover Hydrating Tinted Sunscreen SPF50

FITCOVER HYDRATING TINTED SUNSCREEN SPF50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83252-004
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SODIUM HINOKITIOL (UNII: 5MPS47D679)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYALURONIC ACID (UNII: S270N0TRQY)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CANDELILLA WAX (UNII: WL0328HX19)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCONUT OIL (UNII: Q9L0O73W7L)
TOCOPHEROL (UNII: R0ZB2556P8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83252-004-11	0.07 kg in 1 JAR; Type 0: Not a Combination Product	02/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/24/2023

Labeler - Veganic SKN Limited (743536682)

Registrant - Veganic SKN Limited (743536682)

Establishment
Name	Address	ID/FEI	Business Operations
Veganic SKN Limited		743536682	manufacture(83252-004) , pack(83252-004) , label(83252-004)

Revised: 2/2023

Document Id: f556e1fa-d732-392f-e053-2995a90aa0e1

34390-5

Set id: f556e1fa-d731-392f-e053-2995a90aa0e1

Version: 1

Effective Time: 20230222