NDC 76354-603 Elf Beige Acne Fighting Foundation

Salicylic Acid

NDC Product Code 76354-603

NDC Code: 76354-603

Proprietary Name: Elf Beige Acne Fighting Foundation Additional informationCallout TooltipWhat 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: Salicylic Acid Additional informationCallout TooltipWhat 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
    • 76354-603 - Elf Beige Acne Fighting Foundation

NDC 76354-603-01

Package Description: 36 mL in 1 BOTTLE

NDC Product Information

Elf Beige Acne Fighting Foundation with NDC 76354-603 is a a human over the counter drug product labeled by J. A. Cosmetics U.s. Inc. The generic name of Elf Beige Acne Fighting Foundation is salicylic acid. 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 Additional informationCallout TooltipWhat 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 Beige Acne Fighting Foundation Active Ingredient(s)

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

  • SALICYLIC ACID .5 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CAMPHOR OIL (UNII: 75IZZ8Y727)
  • DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • NYLON-12 (UNII: 446U8J075B)
  • TALC (UNII: 7SEV7J4R1U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WITCH HAZEL (UNII: 101I4J0U34)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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: part358H Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Elf Beige Acne Fighting Foundation Product Label Images

Elf Beige Acne Fighting Foundation 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:Salicylic Acid 0.5%

Otc - Purpose

Purpose:Acne Treatment

Indications & Usage

Uses:For the treatment of acneHelps prevent new acne blemishes

Warnings

Warning:For external use only

Otc - When Using

When Using This Product:Keep out of eyes, rinse with water to remove.Skin irrittion and dryness is more likely to occur if you use another topical acne medications at the same time.  If irritation occurs, only use one medication at a time.

Otc - Ask Doctor

Stop use and ask a doctor If


rash occurs

Otc - Keep Out Of Reach Of Children

Keep Out of Reach of Children

Dosage & Administration

Directions:Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredient

Inactive Ingredient:Water,  Cyclopentasiloxane, Hydrogenated Polyisobutene, Ethoxydiglycol, Dimethicone, Cyclohexasiloxane, Dimethicone Crossploymer, PEG-10 Dimethicone, Dimethicone PEG 10/15 Crosspolymer, Magnesium Sulfate, Talc, Nylon-12, Phenoxyethanol, Propylene Glycol, Quaternium-18 Benonite, Triethoxycaprylysilane, Methylparaben, Ethylparaben, butylparaben, Propylparaben, Isobutylparaben, Cinnamomum Camphora (Camphor) Bark oil, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Jiuce, Hexapeptide-9, Hamamelis Birginiana (Witch Hazel)


May Contain:


Iron Oxide (CI77491, CI77492, CI77499), Titanium Dioxide

* Please review the disclaimer below.

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