SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE- zinc oxide, octinoxate cream 
Vitality Institute Medical Products

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

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

Octinoxate 7.5% .............. 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

Vitaliy Institute Skin Care System

SPF 50+

Sunscreen Broad Spectrum

2 FL OZ/306mL

2 FL OZ

1 FL OZ

SUNSCREEN BROAD SPECTRUM SPF 50  VITALITY INSTITUTE
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69718-155
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 17.5 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 17.5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
C12-15 ALKYL 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:69718-155-021 in 1 BOX
1NDC:69718-155-0130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:69718-155-041 in 1 BOX
2NDC:69718-155-0359 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 - Vitality Institute Medical Products (056496844)
Registrant - VEGE-KURL, INC (021072509)
Establishment
NameAddressID/FEIBusiness Operations
VEGE-KURL, INC021072509manufacture(69718-155)

Revised: 4/2015
Document Id: b9a1d098-9d70-40fd-a3ec-cac0522330db
Set id: 507c46c3-3fd8-491e-850c-3060c7f488cd
Version: 7
Effective Time: 20150410
 
Vitality Institute Medical Products