VERTRA Premium Suncare SPF 30 Spray

VERTRA Premium Suncare SPF 30 Spray

Drug Labeling and Warnings

Drug Details

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VERTRA PREMIUM SUNCARE SPF 30- titanium dioxide, zinc oxide lotion 
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.

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VERTRA Premium Suncare SPF 30 Spray

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:

LabelLabel2

VERTRA PREMIUM SUNCARE SPF 30 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71014-029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CORN (UNII: 0N8672707O)  
PROPANEDIOL (UNII: 5965N8W85T)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
COCONUT OIL (UNII: Q9L0O73W7L)  
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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CARROT (UNII: L56Z1JK48B)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATERMELON (UNII: 231473QB6R)  
NORI (UNII: 477TV3P5UX)  
MANGO (UNII: I629I3NR86)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71014-029-00177 mL in 1 CAN; Type 0: Not a Combination Product02/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/21/2019
Labeler - Eai-Jr286, Inc. (827896718)

Revised: 3/2019
 
Eai-Jr286, Inc.


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