NDC 49967-994 La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes
Avobenzone, Homosalate, Octisalate And Octocrylene Lotion Topical

Product Information

La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes is a human over the counter drug product labeled by L'oreal Usa Products Inc. The generic name of La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes is avobenzone, homosalate, octisalate and octocrylene. The product's dosage form is lotion and is administered via topical form.

Product Code49967-994
Proprietary Name 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.
La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes
Non-Proprietary Name 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.
Avobenzone, Homosalate, Octisalate And Octocrylene
Product Type 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.
Human Otc Drug
Dosage FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
L'oreal Usa Products Inc
Labeler Code49967
FDA Application Number 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.
part352
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-01-2015
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes?


Product Packages

NDC 49967-994-01

Package Description: 1 BOTTLE in 1 CARTON > 50 mL in 1 BOTTLE

NDC 49967-994-02

Package Description: 3 mL in 1 PACKET

NDC 49967-994-03

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

Product Details

What are La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes Active Ingredients UNII Codes

La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes Inactive Ingredients UNII Codes

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.

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La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum Spf 60 Sunscreen Water Resistant 80 Minutes Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%


Purpose



Sunscreen


Uses



  • 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


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


Keep Out Of Reach Of Children.



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


Directions



For sunscreen use:

●  apply generously 15 minutes before sun exposure

●  reapply:

   ●  after 80 minutes of swimming or sweating

    ●  immediately after towel drying

    ●  at least every 2 hours

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

●  children 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, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, methyl methacrylate crosspolymer, nylon-12, PEG-100 stearate, glyceryl stearate, perlite, beeswax, ammonium polyacryloyldimethyl taurate, phenoxyethanol, PEG-8 laurate, behenyl alcohol, sodium stearoyl glutamate, chlorphenesin, p-anisic acid, xanthan gum, tocopherol, disodium EDTA, arachidyl alcohol, diethylhexyl syringylidenemalonate, propylene glycol, cassia alata leaf extract, maltodextrin, stearyl alcohol, t-butyl alcohol, caprylic/capric triglyceride


Questions Or Comments?



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