VERTRA Premium Suncare SPF 50: Package Insert and Label Information

VERTRA PREMIUM SUNCARE SPF 50- titanium dioxide and zinc oxide spray
Eai-Jr286, 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.

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

Other Information

Protect this product from excessive heat and direct sunlight

Questions or comments?

www.vertra.com

Package Labeling:

Label4
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Label3
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VERTRA PREMIUM SUNCARE SPF 50
titanium dioxide, zinc oxide spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71014-027
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 50 mg in 1 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
ETHYLHEXYL PALMITATE
CORN
PROPANEDIOL
MEDIUM-CHAIN TRIGLYCERIDES
TRIDECYL SALICYLATE
DECYL GLUCOSIDE
GLYCERYL MONOSTEARATE
COCONUT OIL
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)
GLYCERIN
STEARIC ACID
GLYCERYL CAPRYLATE
GLYCERYL 1-UNDECYLENATE
CETOSTEARYL ALCOHOL
CARROT
GREEN TEA LEAF
WATERMELON
NORI
MANGO
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71014-027-00 177 mL in 1 CAN None
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)

Revised: 03/2020 Eai-Jr286, Inc.

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