NDC 76354-617 Elf Beautifully Bare Foundation Serum Broad Spectrum Spf 25 Sunscreen Fair Light

Zinc Oxide

NDC Product Code 76354-617

NDC Code: 76354-617

Proprietary Name: Elf Beautifully Bare Foundation Serum Broad Spectrum Spf 25 Sunscreen Fair Light 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: Zinc Oxide 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.


Code Structure
  • 76354 - J. A. Cosmetics U.s. Inc
    • 76354-617 - Elf Beautifully Bare Foundation Serum Broad Spectrum Spf 25 Sunscreen Fair Light

NDC 76354-617-01

Package Description: 14 mL in 1 BOTTLE

NDC Product Information

Elf Beautifully Bare Foundation Serum Broad Spectrum Spf 25 Sunscreen Fair Light with NDC 76354-617 is a a human over the counter drug product labeled by J. A. Cosmetics U.s. Inc. The generic name of Elf Beautifully Bare Foundation Serum Broad Spectrum Spf 25 Sunscreen Fair Light is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: J. A. Cosmetics U.s. Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.


Elf Beautifully Bare Foundation Serum Broad Spectrum Spf 25 Sunscreen Fair Light 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.

  • ZINC OXIDE 13.8 g/100mL

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)
  • ISODODECANE (UNII: A8289P68Y2)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • DISODIUM HEDTA (UNII: KME849MC7A)
  • SODIUM CHLORATE (UNII: T95DR77GMR)
  • QUATERNIUM-18 (UNII: O7757NO1VL)
  • BENTONITE (UNII: A3N5ZCN45C)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • TALC (UNII: 7SEV7J4R1U)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)

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: J. A. Cosmetics U.s. Inc
Labeler Code: 76354
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: 03-30-2019 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.

Elf Beautifully Bare Foundation Serum Broad Spectrum Spf 25 Sunscreen Fair Light Product Label Images

Elf Beautifully Bare Foundation Serum Broad Spectrum Spf 25 Sunscreen Fair Light 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

Otc - Active Ingredient

Active Ingredient:Zinc Oxide: 13.8%

Otc - Purpose

Purpose:Sunscreen

Indications & Usage

Uses:Help prevent sunburnIf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

Warning:For external use onlyDo not use on damaged or broken skin

Otc - When Using

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

Otc - Ask Doctor

Stop Use and Ask a Doctor if:Rash occurs

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of ChildrenIf swallowed, get medical help or contact a poison control center immediately

Dosage & Administration

  • Directions:For sunscreen use:Apply generously 15 min before sun exposure. Reapply every two hours.Use a water resistant sunscreen if swimming or sweatingSun Protection Measures:Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures includingLimit time in the sun, especially from 10 am to 2 pmWear long sleeved shirts, pants, hats, and sunglasses.Children under six months of age: ask a doctorOther Information:Protect this product in the container from excessive heat and direct sun

Inactive Ingredient

Inactive Ingredient:Cyclopentasiloxane, Water, Dimethicone, Silica, Isododecane, PEG-10 Dimethicone, Acrylates/Dithicone Copolymer, PEG-9 Dimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Quaternium-18, Bentonite, Dimethicone/PEG-10/15 Crosspolymer, Propylene Carbonate, Triethoxycaprylsilane, Talc, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Pentaerythrityl Tetraisosterate, Paraffinum Liquidum (Mineral Oil), Disteardimonium Hectorite, Palmitoyl Tripeptide-1, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Retinyl Palmitate (Va), Tocopheryl Acetate (Ve), Ascorbyl Palmitate (Vc), Lycium Barbarum Fruit ExtractMay contain:Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide

* Please review the disclaimer below.

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