SUNSCREEN BROAD SPECTRUM SPF 50 VITALITY INSTITUTE- zinc oxide, octinoxate cream

Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Sunscreen Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by Vitality Institute Medical Products, VEGE-KURL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients             Purpose

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

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

PURPOSE

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.

INDICATIONS & USAGE

• Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

• For external use only
• When using this product keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION

Directions

• Apply evenly 15 minutes before sun exposure
• Reapply at least every 2 hours or after towel drying, swimming or sweating
• Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including

• Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10am-2pm

• wear long-sleeved shirts, pants, hats, and sunglasses

• children under 6 months of age: Askj a doctor

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Vitaliy Institute Skin Care System

SPF 50+

Sunscreen Broad Spectrum

2 FL OZ/306mL

INGREDIENTS AND APPEARANCE

SUNSCREEN BROAD SPECTRUM SPF 50  VITALITY INSTITUTE
zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69718-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 17.5 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 17.5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69718-155-02	1 in 1 BOX
1	NDC: 69718-155-01	30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69718-155-04	1 in 1 BOX
2	NDC: 69718-155-03	59 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/26/2015

Labeler - Vitality Institute Medical Products (056496844)

Registrant - VEGE-KURL, INC (021072509)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC		021072509	manufacture(69718-155)