NDC 49967-017 La Roche Posay Laboratoire Dermatologique Anthelios Sx Daily Moisturizing Sunscreen Broad Spectrum Spf 15

Avobenzone, Ecamsule And Octocrylene

NDC Product Code 49967-017

NDC CODE: 49967-017

Proprietary Name: La Roche Posay Laboratoire Dermatologique Anthelios Sx Daily Moisturizing Sunscreen Broad Spectrum Spf 15 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, Ecamsule And Octocrylene 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

  • 49967 - L'oreal Usa Products Inc
    • 49967-017 - La Roche Posay Laboratoire Dermatologique Anthelios Sx Daily Moisturizing Sunscreen Broad Spectrum Spf 15

NDC 49967-017-01

Package Description: 1 TUBE in 1 CARTON > 100 g in 1 TUBE

NDC Product Information

La Roche Posay Laboratoire Dermatologique Anthelios Sx Daily Moisturizing Sunscreen Broad Spectrum Spf 15 with NDC 49967-017 is a a human over the counter drug product labeled by L'oreal Usa Products Inc. The generic name of La Roche Posay Laboratoire Dermatologique Anthelios Sx Daily Moisturizing Sunscreen Broad Spectrum Spf 15 is avobenzone, ecamsule and octocrylene. The product's dosage form is cream and is administered via topical form.

Labeler Name: L'oreal Usa Products 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.

La Roche Posay Laboratoire Dermatologique Anthelios Sx Daily Moisturizing Sunscreen Broad Spectrum Spf 15 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.

  • AVOBENZONE 20 mg/g
  • ECAMSULE 20 mg/g
  • OCTOCRYLENE 100 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.

  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: L'oreal Usa Products Inc
Labeler Code: 49967
FDA Application Number: NDA021502 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: NDA - A product marketed under an approved New Drug Application. 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: 07-29-2014 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.

La Roche Posay Laboratoire Dermatologique Anthelios Sx Daily Moisturizing Sunscreen Broad Spectrum Spf 15 Product Label Images

La Roche Posay Laboratoire Dermatologique Anthelios Sx Daily Moisturizing Sunscreen Broad Spectrum Spf 15 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 2%Ecamsule 2%Octocrylene 10%

Purpose

Sunscreen

Uses

- helps prevent sunburn- higher SPF gives more sunburn protection- helps provide protection from UVA rays (short and long wavelengths)

Warnings

For external use only

Do Not Use On

- broken skin- serious burns

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

Rash or irritation develops and lasts

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- apply evenly before sun exposure- reapply as needed or after towel drying, swimming, or perspiring- children under 6 months of age: ask a doctor

Inactive Ingredients

Carbomer homopolymer Type C, carbomer copolymer Type B, cyclomethicone, dimethicone, edetate disodium, glycerin, hydroxypropyl methylcellulose, isopropyl palmitate, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearic acid, stearoyl macrogolglycerides, stearyl alcohol, trolamine

Questions?

1-800-308-4516Monday - Friday (9 a.m. to 5 p.m. EST)

* Please review the disclaimer below.