WEAR ME TINTED SUNSCREEN FOR ACNE PRONE SKIN- 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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Wear Me Tinted Sunscreen for Acne Prone Skin

Label

WEAR ME TINTED SUNSCREEN FOR ACNE PRONE SKIN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83252-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL (UNII: 724GKU717M)  
CANDELILLA WAX (UNII: WL0328HX19)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SODIUM HINOKITIOL (UNII: 5MPS47D679)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHAMOMILE (UNII: FGL3685T2X)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83252-007-070.05 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/27/2023
Labeler - Veganic SKN Limited (743536682)
Establishment
NameAddressID/FEIBusiness Operations
Veganic SKN Limited743536682label(83252-007) , manufacture(83252-007) , pack(83252-007)

Revised: 2/2023
Document Id: f5a6cd2e-9d28-4d04-e053-2a95a90af908
Set id: f5a6cd2e-9d27-4d04-e053-2a95a90af908
Version: 1
Effective Time: 20230226
 
Veganic SKN Limited