NDC 0023-4953 Skinmedica Tns Ultimate Daily Moisturizer Sunscreen Spf 20

Octinoxate, Zinc Oxide

NDC Product Code 0023-4953

NDC Code: 0023-4953

Proprietary Name: Skinmedica Tns Ultimate Daily Moisturizer Sunscreen Spf 20 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: Octinoxate, Zinc Oxide 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

NDC 0023-4953-02

Package Description: 1 TUBE in 1 CARTON > 56.7 g in 1 TUBE

NDC 0023-4953-13

Package Description: 12 TUBE in 1 CARTON > 3.7 g in 1 TUBE

NDC Product Information

Skinmedica Tns Ultimate Daily Moisturizer Sunscreen Spf 20 with NDC 0023-4953 is a a human over the counter drug product labeled by Allergan, Inc.. The generic name of Skinmedica Tns Ultimate Daily Moisturizer Sunscreen Spf 20 is octinoxate, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Allergan, 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 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.

Skinmedica Tns Ultimate Daily Moisturizer Sunscreen Spf 20 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.

  • OCTINOXATE 75 mg/g
  • ZINC OXIDE 53 mg/g

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)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • SQUALANE (UNII: GW89575KF9)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
  • UBIDECARENONE (UNII: EJ27X76M46)
  • PIKEA ROBUSTA (UNII: 1HL404JO0I)
  • CERAMIDE 3 (UNII: 4370DF050B)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • POLYISOBUTYLENE (35000 MW) (UNII: 98553S1MHQ)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ISOCETETH-20 (UNII: O020065R7Z)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

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: Allergan, Inc.
Labeler Code: 0023
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: 01-01-2013 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: 12-31-2020 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.

Skinmedica Tns Ultimate Daily Moisturizer Sunscreen Spf 20 Product Label Images

Skinmedica Tns Ultimate Daily Moisturizer Sunscreen Spf 20 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

Other

Drug Facts

Active Ingredients

Octinoxate 7.5%
Zinc Oxide 5.3%

Purpose

Sunscreen
Sunscreen

Use

  • Helps prevent sunburn.
  • If 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.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash or irritation develops and lasts.

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

  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: ask a doctor.
  • 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 a.m. – 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.

Other Information

  • Protect the product in this container from excessive heat and direct sun.
  • Store at room temperature 15° - 30°C (59° - 86°F).

Inactive Ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Squalane, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Human Fibroblast Conditioned Media, Saccharomyces Ferment Lysate Filtrate, Ubiquinone, Pikea Robusta Extract, Ceramide NP, Butyrospermum Parkii (Shea Butter), Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Tocopherol, Panthenol, Glycine Soja (Soybean) Extract, Butylene Glycol, Cetearyl Alcohol, Ceteareth-20, Polyacrylate-13, Polyisobutene, Polysorbate 20, Isoceteth-20, Xanthan Gum, Ethoxydiglycol, Triethoxycaprylylsilane, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben

* Please review the disclaimer below.