NDC 71014-029 Vertra Premium Suncare Spf 30

Titanium Dioxide, Zinc Oxide

NDC Product Code 71014-029

NDC 71014-029-00

Package Description: 177 mL in 1 CAN

NDC Product Information

Vertra Premium Suncare Spf 30 with NDC 71014-029 is a a human over the counter drug product labeled by Eai-jr286, Inc.. The generic name of Vertra Premium Suncare Spf 30 is titanium dioxide, zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Eai-jr286, Inc.

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 Premium Suncare Spf 30 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.

  • TITANIUM DIOXIDE 40 mg/mL
  • ZINC OXIDE 40 mg/mL

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.

  • 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)

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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-21-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Vertra Premium Suncare Spf 30 Product Label Images

Vertra Premium Suncare Spf 30 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 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

* Please review the disclaimer below.

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