NDC 68327-074 Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 68327-074

NDC Code: 68327-074

Proprietary Name: Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen 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: Avobenzone, Homosalate, Octisalate, 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

  • 68327 - Cover Fx Skin Care Inc.
    • 68327-074 - Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen

NDC 68327-074-01

Package Description: 1 BOTTLE, GLASS in 1 BOX > 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen with NDC 68327-074 is a a human over the counter drug product labeled by Cover Fx Skin Care Inc.. The generic name of Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is oil and is administered via topical form.

Labeler Name: Cover Fx Skin Care Inc.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen 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.

  • HOMOSALATE 100 mg/mL
  • OCTISALATE 50 mg/mL
  • AVOBENZONE 30 mg/mL
  • OCTOCRYLENE 100 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.

  • SALICORNIA EUROPAEA (UNII: 6ADL50JAKW)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • COCONUT (UNII: 3RT3536DHY)

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: Cover Fx Skin Care Inc.
Labeler Code: 68327
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: 03-01-2019 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: 12-31-2020 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.

Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen Product Label Images

Cover Fx Spf 30 Booster Drops Broad Spectrum Sunscreen 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

Active Ingredients:Avobenzone 3.0%Homosalate 10.0%Octisalate 5.0%Octocrylene 10.0%Purpose: Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of the 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 at least every 2 hours.Use a water resistant sunscreen if swimming or sweating.Children under 6 months of age, ask a doctor.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 of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.-2 p.m.wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sunStore at 15 – 30 °CReport serious adverse event to: 575 Fifth Ave 14th Floor, New York, NY10017

Inactive Ingredients

Neopentyl Glycol Diheptanoate, Caprylic/Capric Triglyceride, Dimethicone, Butyloctyl Salicylate, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Acrylates/Dimethicone Copolymer, Cocos Nucifera (Coconut) Fruit Extract, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Bisabolol, Salicornia Herbacea Extract.

Questions?

Call 866-424-3332 M-F 9:00am – 5:00pm EST

Company Information

DIST BY COVER FX SKIN CARE INC.TORONTO, ONTARIO CANADA M3J 2W8MADE IN USAWWW.COVERFX.COM

Product Packaging

COVER FXSPF 30 BOOSTER DROPSBROAD SPECTRUM SUNSCREEN30 mL/1.0 FL OZ

* Please review the disclaimer below.

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