NDC 10345-101 Loccitane En Provence Immortelle Precieuse Light Spf20

Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene

NDC Product Code 10345-101

NDC Code: 10345-101

Proprietary Name: Loccitane En Provence Immortelle Precieuse Light Spf20 Additional informationCallout TooltipWhat 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, Octinoxate, Octisalate, Octocrylene Additional informationCallout TooltipWhat 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.


Code Structure
  • 10345 - Laboratoires M&l
    • 10345-101 - Loccitane En Provence Immortelle Precieuse Light Spf20

NDC 10345-101-01

Package Description: 1 JAR in 1 BOX > 50 mL in 1 JAR

NDC Product Information

Loccitane En Provence Immortelle Precieuse Light Spf20 with NDC 10345-101 is a a human over the counter drug product labeled by Laboratoires M&l. The generic name of Loccitane En Provence Immortelle Precieuse Light Spf20 is avobenzone, homosalate, octinoxate, octisalate, octocrylene. The product's dosage form is cream and is administered via topical form.

Labeler Name: Laboratoires M&l

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 Additional informationCallout TooltipWhat 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.


Loccitane En Provence Immortelle Precieuse Light Spf20 Active Ingredient(s)

Additional informationCallout TooltipWhat 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 30 mg/mL
  • HOMOSALATE 50 mg/mL
  • OCTINOXATE 75 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 50 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
  • EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
  • BORAGE SEED OIL (UNII: F8XAG1755S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • ADENOSINE (UNII: K72T3FS567)
  • GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • CITRAL (UNII: T7EU0O9VPP)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Laboratoires M&l
Labeler Code: 10345
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-15-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Loccitane En Provence Immortelle Precieuse Light Spf20 Product Label Images

Loccitane En Provence Immortelle Precieuse Light Spf20 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 5%


Octinoxate 7.5%


Octisalate 5%


Octocrylene 5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.If used as directed with other sun protection measures (see
  • Directions) decreases the risk of skin caner and early skin aging caused by the sun.

Warnings

For external use only.

Do Not Use

On damaged or broken skin.

When Usning This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

If rash occurs.

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 exposureReapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweatingSun Protection Measures. Spening time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen 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 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:

AQUA/WATER - GLYCERIN - COCO-CAPRYLATE/CAPRATE -CORN STARCH MODIFIED - CETEARYL ALCOHOL - DIMETHICONE - POTASSIUM CETYL PHOSPHATE - HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER - HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL - HELICHRYSUM ITALICUM FLOWER OIL - HELICHRYSUM ITALICUM EXTRACT - OENOTHERA BIENNIS (EVENING PRIMROSE) OIL - BORAGO OFFICINALIS SEED OIL - CETEARYL GLUCOSIDE - CHLORPHENESIN - TOCOPHEROL - SUCROSE PALMITTE - DISODIUM EDTA - POLYSORBATE 60 - SORBITAN ISOSTEARATE - ADENOSINE - GLYCERYL LINOLEATE - CITRIC ACID - PHENOXYETHANOL - SODIUM BENZOATE - POTASSIUM SORBATE - PARFUM/FRAGRANCE - HYXYL CINNAMAL - BENZYL SALICYLATE - ALPHA-ISOMETHYL IONONE - LINALOOL - CITRAL - LIMONENE

* Please review the disclaimer below.

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