NDC 49967-431 La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum Spf 60 Sunscreen

Avobenzone, Homosalate, Octisalate And Octocrylene Lotion Topical

NDC Product Information

La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum Spf 60 Sunscreen with NDC 49967-431 is a human over the counter drug product labeled by L'oreal Usa Products Inc. The generic name of La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum Spf 60 Sunscreen is avobenzone, homosalate, octisalate and octocrylene. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Sport Anthelios Activewear Broad Spectrum Spf 60 Sunscreen 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)
  • NYLON-12 (UNII: 446U8J075B)
  • PEG-8 LAURATE (UNII: 762O8IWA10)

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: 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: 10-17-2017 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: 12-31-2023 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 - 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.

La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum Spf 60 Sunscreen Product Label Images

La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum Spf 60 Sunscreen 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 15%Octisalate 5%Octocrylene 7%




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


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.


  • Apply generously 15 minutes before sun exposurereapply:after 80 minutes of swimming or sweatingimmediately fter towel dryingat 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 SOF calue of 15 or higher and other sun protection measures including:limit time in the sun, especially between 10 a.m. and 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

Water, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, menthyl methacrylae crosspolymer, nylon-12, PEG-100, glyceryl stearate, perlite, beeswax, ammonium poolyacrylloyldiimethy taurate, behenyl alcohol, caprylic/capric triglyceride, cassia alata leaf extract, chlorphenesisn, diethylhexyl syringlyidenemalonate, disodium EDTA, maltodextrin, p-anisic acid, PEG-8 laurate, phenoxethanol, propylene glycol, sodium stearoyl glutamate, tocopherol, xanthan gum

* Please review the disclaimer below.