Vertra Daily Driver Sunscreen Moisturizer and Anti-Aging SPF30

Vertra Element Resistance Daily Driver by

Drug Labeling and Warnings

Vertra Element Resistance Daily Driver by is a Otc medication manufactured, distributed, or labeled by EAi-JR286, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VERTRA ELEMENT RESISTANCE DAILY DRIVER SPF30- homosalate, octisalate, avobenzone, octocrylene 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 Daily Driver Sunscreen Moisturizer and Anti-Aging SPF30

Active Ingredients

  Homosalate  5%

Octisalate  5%

Avobenzone 3%

Octocrylene 2.7%

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 byt 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 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 measuers including

   limit time in the sun, especially from 10 a.m.-2p.m.

   wear long-sleeve shirts, pants, hats and sunglasses

   Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Butylene Glycol, Caprylyl Glycol, Cetearyl Alcohol, Chlorphenesin, Citrus Sinensis (Blood Orange) Fruit Extract, Coco Caprylate/Caprate, Decyl Glucoside, Dextrin, Dimethicone, Disodium EDTA, Ethylhexyl Stearate, Fragrance, Glycerin, Glyceryl Stearate,
Hydrolyzed Hibiscus Esculentus Extract, Isododecane, PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Polysilicone-11, Polyurethane-34, Sodium Citrate, Sodium Polyacrylate, Tapioca Starch Polymethylsilsesquioxane, Tocopheryl Acetate, Trideceth 6, Water,
Xanthan Gum

VERTRA ELEMENT RESISTANCE DAILY DRIVER  SPF30
homosalate, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71014-371
Route of Administration	topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ABELMOSCHUS ESCULENTUS WHOLE (UNII: 505GKC6541)
ISODODECANE (UNII: A8289P68Y2)
PEG-100 STEARATE (UNII: YD01N1999R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
STARCH, TAPIOCA (UNII: 24SC3U704I)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
water (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71014-371-02	1 in 1 CARTON	02/01/2019
1	NDC: 71014-371-01	50 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	02/01/2019	02/28/2022

Labeler - EAi-JR286, INC (827896718)

Revised: 12/2021

Document Id: fcae1456-2981-4d33-9e04-78802a226d4e

34390-5

Set id: 3cac278e-459c-44ec-8044-5b27632e4bad

Version: 3

Effective Time: 20211210