SUNSCREEN BROAD SPECTRUM SPF 50 VI AESTHETICS- zinc oxide, octinoxate cream 
Vi Medical Products, INC

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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Vitality Institute Skin Care System SPF 50+

Active Ingredients             Purpose

Octinoxate  7.5% .............  Sunscreen

Zinc Oxide  10% ............... Sunscreen

Uses

Warnings


Directions

Inactive Ingredients

Water, C12-15, Alkyl Benzoate, Octyldodecly Neopentanoate, Polysorbate 60, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG - 100 Stearate, Coconut Alkanes, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Dimethicone, Aloe Barbadensis Leaf Extract, Citrus Grandis Fruit Extract, Anthemis Nobilis Flower Extract, Pueraria Lobata Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Benzyl Alcohol, Ehtylhexylglycerin, Phenoxyethanol

VI Derm

SPF 50+ Cream

Sunscreen Broad Spectrum

59 ml/2 FL OZ

Label 2oz.

SUNSCREEN BROAD SPECTRUM SPF 50  VI AESTHETICS
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70484-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Glycerin (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PUMMELO (UNII: ET1TN5W71X)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70484-005-021 in 1 BOX03/26/2015
1NDC:70484-005-0130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:70484-005-041 in 1 BOX03/26/2015
2NDC:70484-005-0359 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/26/2015
Labeler - Vi Medical Products, INC (063910521)
Registrant - VEGE-KURL, INC (021072509)
Establishment
NameAddressID/FEIBusiness Operations
VEGE-KURL, INC021072509manufacture(70484-005)

Revised: 3/2017
Document Id: 44ef6ced-45af-43fe-a974-8efd5972ff3d
Set id: 73620765-c7c0-4bd7-82a9-00022773c928
Version: 4
Effective Time: 20170316
 
Vi Medical Products, INC