NDC 56152-5001 Skin Balancing Ultra Sheer Daily Defence Spf 30 Paulas Choice

Avobenzone, Homosalate, Octocrylene, Oxybenzone

NDC Product Code 56152-5001

NDC CODE: 56152-5001

Proprietary Name: Skin Balancing Ultra Sheer Daily Defence Spf 30 Paulas Choice 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, Oxybenzone 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

  • 56152 - Cosmetic Enterprises Ltd

NDC 56152-5001-1

Package Description: 1.5 mL in 1 PACKET

NDC 56152-5001-2

Package Description: 60 mL in 1 TUBE

NDC Product Information

Skin Balancing Ultra Sheer Daily Defence Spf 30 Paulas Choice with NDC 56152-5001 is a a human over the counter drug product labeled by Cosmetic Enterprises Ltd. The generic name of Skin Balancing Ultra Sheer Daily Defence Spf 30 Paulas Choice is avobenzone, homosalate, octocrylene, oxybenzone. The product's dosage form is cream and is administered via topical form.

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.

Skin Balancing Ultra Sheer Daily Defence Spf 30 Paulas Choice 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.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
  • ADENOSINE (UNII: K72T3FS567)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)
  • OATMEAL (UNII: 8PI54V663Y)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • GINKGO (UNII: 19FUJ2C58T)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • STEARETH-21 (UNII: 53J3F32P58)
  • STEARETH-2 (UNII: V56DFE46J5)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SORBIC ACID (UNII: X045WJ989B)

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: Cosmetic Enterprises Ltd
Labeler Code: 56152
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: 08-12-2016 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.

Skin Balancing Ultra Sheer Daily Defence Spf 30 Paulas Choice Product Label Images

Skin Balancing Ultra Sheer Daily Defence Spf 30 Paulas Choice 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 Ingredients             PurposeAvobenzone 3.0% ........... SunscreenHomosalate 7.0% ............ SunscreenOctocrylene 2.0% ............ SunscreenOxybenzone 4.0% ............ Sunscreen

Otc - Purpose

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

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.

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

WarningsFor external use only. When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration

  • DirectionsApply liberally 15 minutes before sun exposureUse a  water-resistant sunscreen if swimming or sweating:      Imeediately after towel drying      At least every two hoursChildren under 6 months of age: Ask a doctorSun 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 10AM - 2PMWear long-sleeve shirts, pants, hats and sunglasses

Inactive Ingredient

Water (Aqua), Butylene Glycol, Silica, Aluminum Starch Octenylsuccinate, Cetyl Dimethicone, Camelia Sinensis (Green Tea) Leaf Extract, Aloe Barbadensis Leaf Juice Powder, Ascorbyl Palmitate, Phospholipids, Superoxide Dismutase, Adenosine, Tocopherol, Bisabolol, Boerhavia Diffusa Root Extract, Colloidal Oatmeal, Panthenol, Ginkgo Biloba Leaf Extract, Salix Alba (Willow) Bark Extract, Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Titanium Dioxide, Sodium Hydorxide, Steareth-21, Steareth-2, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sorbic Acid

* Please review the disclaimer below.