NDC 65342-0002 Laura Mercier Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Lightweight Flawless Coverage Natural

Octinoxate, Octisalate

NDC Product Code 65342-0002

NDC CODE: 65342-0002

Proprietary Name: Laura Mercier Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Lightweight Flawless Coverage Natural 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, 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

  • 65342 - Gurwitch Products, Llc
    • 65342-0002 - Laura Mercier Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Lightweight Flawless Coverage Natural

NDC 65342-0002-0

Package Description: 50 mL in 1 TUBE

NDC Product Information

Laura Mercier Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Lightweight Flawless Coverage Natural with NDC 65342-0002 is a a human over the counter drug product labeled by Gurwitch Products, Llc. The generic name of Laura Mercier Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Lightweight Flawless Coverage Natural is octinoxate, octisalate. 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.

Laura Mercier Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Lightweight Flawless Coverage Natural 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)
  • PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • SIMMONDSIA CHINENSIS WHOLE (UNII: DFM16KFA82)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
  • SQUALANE (UNII: GW89575KF9)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • LAURYL PCA (UNII: 29C5O2BJYA)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
  • ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)

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: Gurwitch Products, Llc
Labeler Code: 65342
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: 02-06-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Laura Mercier Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Lightweight Flawless Coverage Natural Product Label Images

Laura Mercier Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen Lightweight Flawless Coverage Natural 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

Octinoxate 5.5%Octisalate 3.0%

Purpose

Sunscreen

Uses

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

  • For sunscreen use:apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hoursSun 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 values of 15 or higher and other sun  protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.mwear long-sleeved shirts, pants, hats, and sunglassesChildren under 6 months of age: Ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water, Disiloxane, PEG-30 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Glycerin, Isohexadecane, Cyclopentasiloxane, Phenoxyethanol, Boron Nitride, Jojoba Esters, Magnesium Stearate, Sodium Dehydroacetate, Squalane, Methicone, Disodium EDTA, Methylparaben, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Propylparaben, Lauryl PCA, Tocopheryl Acetate, PPG-15 Stearyl Ether, Isopropyl Titanium Triisostearate, Dipotassium Glycyrrhizate.


May Contain: Titanium Dioxide, Iron Oxides.

* Please review the disclaimer below.