NDC 14222-2300 Reverse Brightening Defense Fluid

Avobenzone, Homosalate, Octocrylene, Octisalate

NDC Product Code 14222-2300

NDC CODE: 14222-2300

Proprietary Name: Reverse Brightening Defense Fluid 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, Octocrylene, Octisalate 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

  • 14222 - Rodan & Fields
    • 14222-2300 - Reverse Brightening Defense Fluid

NDC 14222-2300-1

Package Description: 1 TUBE in 1 CARTON > 30 mL in 1 TUBE

NDC Product Information

Reverse Brightening Defense Fluid with NDC 14222-2300 is a a human over the counter drug product labeled by Rodan & Fields. The generic name of Reverse Brightening Defense Fluid is avobenzone, homosalate, octocrylene, octisalate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Rodan & Fields

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.

Reverse Brightening Defense Fluid 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.

  • AVOBENZONE .028 g/mL
  • HOMOSALATE .093 g/mL
  • OCTOCRYLENE .061 g/mL
  • OCTISALATE .0467 g/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.

  • ADENOSINE (UNII: K72T3FS567)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CALCIUM GLUCONATE (UNII: SQE6VB453K)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • CITRAL (UNII: T7EU0O9VPP)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ROSMARINIC ACID (UNII: MQE6XG29YI)
  • RUTIN (UNII: 5G06TVY3R7)
  • SESAME SEED (UNII: 7Y1255HVXR)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • WATER (UNII: 059QF0KO0R)
  • 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: Rodan & Fields
Labeler Code: 14222
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-09-2021 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Reverse Brightening Defense Fluid 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 2.8%, Homosalate 9.3%, Octisalate 4.67%, Octocrylene 6.1 %

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • When 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 Doctor If

  • Rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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 AM-2 PM.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months:Ask a doctor.

Inactive Ingredients

Adenosine, Aminomethyl Propanol, Aqua/Eau/Water, Benzyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Calcium Gluconate, Citral, Citric Acid, Cynara Scolymus (Artichoke) Leaf Extract, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Fragrance/Parfum, Gluconolactone, Glycerin, Hydrogenated Lecithin, Limonene, Linalool, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Phenoxyethanol, Propanediol, Rosmarinic Acid, Rutin, Sesamum Indicum (Sesame) Seed Extract, Silica, Sodium Benzoate, Sodium Carbomer, Titanium Dioxide (Cl 77891), Tocopherol, Xanthan Gum.

Other Information

Protect this product from excessive heat and direct sun.

Questions?

1-888-995-5656

* Please review the disclaimer below.