VERTRA PREMIUM SUNCARE SPF 50- titanium dioxide, zinc oxide lotion

VERTRA Premium Suncare SPF 50 by

Drug Labeling and Warnings

VERTRA Premium Suncare SPF 50 by is a Otc medication manufactured, distributed, or labeled by EAI-JR286, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Titanium Dioxide 5.0%
Zinc Oxide 5.0%

Purpose

Sunscreen

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

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes

Rinse with water to remove

Stop use and ask a doctor

if rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure  Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours  Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m. - 2p.m. Wear long-sleeve shirts, pants, hats, and sunglasses  Children under 6 months: Ask a doctor

Inactive Ingredients

Aqua (Deonized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ethylhexyl Palmitate, Zemea (Corn) Propanediol, Glyceryl Stearate, Tridecyl Salicylate, Helianthus Annuus (Sunflower) Oil, Decyl Glucoside, Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Glycerin, Stearic Acid, Glyceryl Caprylate, Glyceryl Undecylenate, Parfum (Fragrance), Algae Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Mangifera Indica (Mango) Butter, Tocopheryl Acetate (Vitamin E), Fucus Vesiculosus (Seaweed) Extract, Hippophae Rhamnoides (Sea Buckthorn) Oil, Xanthan Gum, Hydroxyethylcellulose, Cetearyl Alcohol.

Other Information

Protect this product from excessive heat and direct sunlight

Questions or comments?

www.vertra.com

Package Labeling:

INGREDIENTS AND APPEARANCE

VERTRA PREMIUM SUNCARE SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CORN (UNII: 0N8672707O)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
COCONUT OIL (UNII: Q9L0O73W7L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATERMELON (UNII: 231473QB6R)
CARROT (UNII: L56Z1JK48B)
MANGO (UNII: I629I3NR86)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NORI (UNII: 477TV3P5UX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-017-00	1 in 1 BOX	02/21/2019
1		90 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71014-017-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/21/2019

Labeler - EAI-JR286, Inc (827896718)