NDC 71014-371 Vertra Element Resistance Daily Driver Spf30

Homosalate, Octisalate, Avobenzone, Octocrylene

NDC Product Code 71014-371

NDC CODE: 71014-371

Proprietary Name: Vertra Element Resistance Daily Driver Spf30 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Homosalate, Octisalate, Avobenzone, Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 71014 - Eai-jr286, Inc
    • 71014-371 - Vertra Element Resistance Daily Driver

NDC 71014-371-02

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE (71014-371-01)

NDC Product Information

Vertra Element Resistance Daily Driver Spf30 with NDC 71014-371 is a a human over the counter drug product labeled by Eai-jr286, Inc. The generic name of Vertra Element Resistance Daily Driver Spf30 is homosalate, octisalate, avobenzone, octocrylene. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Vertra Element Resistance Daily Driver Spf30 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eai-jr286, Inc
Labeler Code: 71014
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Vertra Element Resistance Daily Driver Spf30 Product Label Images

Vertra Element Resistance Daily Driver Spf30 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Homosalate  5%Octisalate  5%Avobenzone 3%Octocrylene 2.7%

Purpose

Sunscreen

Uses

  • Helps prevent SunburnIf 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 eyesRinse 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 exposureReapply:   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

* Please review the disclaimer below.