NDC 14222-2250 Rodan And Fields Redefine Am Spf 30

Octisalate, Avobenzone, Octocrylene, Homosalate

NDC Product Code 14222-2250

NDC CODE: 14222-2250

Proprietary Name: Rodan And Fields Redefine Am Spf 30 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: Octisalate, Avobenzone, Octocrylene, Homosalate 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 And Fields

NDC 14222-2250-2

Package Description: 1 JAR in 1 CARTON > 30 mL in 1 JAR (14222-2250-1)

NDC Product Information

Rodan And Fields Redefine Am Spf 30 with NDC 14222-2250 is a a human over the counter drug product labeled by Rodan And Fields. The generic name of Rodan And Fields Redefine Am Spf 30 is octisalate, avobenzone, octocrylene, homosalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Rodan And Fields

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.

Rodan And Fields Redefine Am Spf 30 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.

  • OCTISALATE 5 g/100mL
  • AVOBENZONE 3 g/100mL
  • OCTOCRYLENE 2.7 g/100mL
  • HOMOSALATE 2.5 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)
  • SUCROSE STEARATE (UNII: 274KW0O50M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISODODECANE (UNII: A8289P68Y2)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • TALC (UNII: 7SEV7J4R1U)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
  • DUNALIELLA SALINA (UNII: F4O1DKI9A6)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • TETRAPEPTIDE-21 (UNII: 179JUC43HU)
  • BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
  • BLACK OLIVE (UNII: 2M6QWV94OC)
  • PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • RESVERATROL (UNII: Q369O8926L)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

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 And 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 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: 05-01-2013 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: 12-31-2021 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.

Rodan And Fields Redefine Am Spf 30 Product Label Images

Rodan And Fields Redefine Am Spf 30 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%Homosalate  2.5%Octisalate  5%Octocrylene  2.7%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

  • Apply a dime-sized amount evenly over entire face every morning and 15 minutes before sun exposure, avoiding the eye area.Use a water resistant sunscreen if swimming or sweatingReapply at least every 2 hours.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 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-sleeve shirts, pants, hats and sunglassesChildren under 6 months: Ask a doctor.

Inactive Ingredients

Water, Isododecane, Ethylhexyl Pamitate, Polymethylsilsesquioxane, Glycerin, Dimethicone, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Caprylyl Glycol, Sucrose Stearate, Olea Europaea (Olive) Fruit Extract, Hydrogenated Polydecene, Polyurethane-40, Hydrolyzed Silk, Fragrance, Silica, Camellia Oleifera Leaf Extract, Polyacrylate-13, Polyisobutene, Polysorbate-20, Iron Oxides, Tetrapeptide-21,  Resveratrol, Phenoxyethanol, Chlorphenesin, Dunaliella Salina Extract, Talc, PEG-12 Dimethicone, Humic Acids, Sodium Hyaluronate

Other Information

Protect this product from excessive heat and direct sun

* Please review the disclaimer below.