NDC 50518-202 Face Balm Spf-15

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 50518-202

NDC 50518-202-11

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Face Balm Spf-15 with NDC 50518-202 is a a human over the counter drug product labeled by Custom Research Labs. The generic name of Face Balm Spf-15 is avobenzone, homosalate, octisalate, 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.

Face Balm Spf-15 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.

  • PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PANAX GINSENG FLOWER (UNII: 3V5S2B524J)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER 1342 (UNII: 809Y72KV36)
  • CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
  • ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Custom Research Labs
Labeler Code: 50518
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: 07-06-2021 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.

Face Balm Spf-15 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

AVOBENZONE (3.0%)HOMOSALATE (5.0%)OCTISALATE (3.0%)OCTOCRYLENE (3.0%)

Purpose

SUNSCREEN

Uses

Apply to cleansed skin, gently smoothing over the face and neck. For best results, follow the complete Urth Skin Solutions regimen. Appliquer sur une peau nettoyee en lissant delicatement le visage et le cou. Pour de meilleurs resultats, suivez le regime complet d'Urth Skin Solutions.

Caution/ Attention

For external use only. Avoid eye contact. Store in cool, dry area. Pour usage externe suelement. Eviter le contact des yeaus. Conserver dans un endroit frais et sec.

Inactive Ingredients

Water (Aqua), Propylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Carthamus Tinctorus (Safflower) Seed Oil, Stearic Acid, Cetyl Alcohol, Ethylhexyl Glycerin, Xanthan Gum, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Sodium Hydroxide, Sodium Hyaluronate, Niacinamide, Camellia Sinensis (White Tea) Leaf Extract, Ascorbic Acid (Vit. C), Tocopheryl Acetate (Vit.E), Aloe Barbadensis Leaf Extract, Panex Ginseng Extract, Salix Alba (Willow) Bark Extract, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Avena Sativa (Oat) Kernel Flour, Phenoxyethanol.

* Please review the disclaimer below.