NDC 70581-003 Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing
Avobenzone, Octisalate, Octocrylene Cream Topical; Topical

Product Information

What is NDC 70581-003?

The NDC code 70581-003 is assigned by the FDA to the product Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing which is a human over the counter drug product labeled by Bps 60. The generic name of Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing is avobenzone, octisalate, octocrylene. The product's dosage form is cream and is administered via topical; topical form. The product is distributed in a single package with assigned NDC code 70581-003-75 1 bottle in 1 box / 75 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code70581-003
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.
Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing
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, Octisalate, 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 FormCream - 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.
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.
  • 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.
Bps 60
Labeler Code70581
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.
04-09-2016
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 Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing?


Product Packages

NDC Code 70581-003-75

Package Description: 1 BOTTLE in 1 BOX / 75 mL in 1 BOTTLE

Product Details

What are Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing 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.

Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing Active Ingredients UNII Codes

Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing 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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Absolue Premium Bx Sunscreen Broad Spectrum Spf 15 Absolute Replenishing Product Label

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.

Product Label Table of Contents



Drug Facts




Active Ingredients



Avobenzone 3%

Octisalate 3%

Octocrylene 8%


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 and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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, glycerin, cyclohexasiloxane, alcohol denat., caprylic/capric triglyceride, PEG-20 methyl glucose sesquistearate, C12-15 alkyl benzoate, tocopheryl acetate, C13-14 isoparaffin, hydroxypropyl tetrahydropyrantriol, hydrolyzed malt extract, padina pavonica extract, hydrolyzed soy protein, stearic acid, adenosine, triethanolamine, polyacrylamide, calcium pantothenate, dimethyl isosorbide, limonene, xanthan gum, linalool, dioscorea villosa (wild yam) root extract, iron oxides, caprylyl glycol, capryloyl salicylic acid, paraffin, disodium EDTA, butylene glycol, cetyl alcohol, octyldodecanol, citronellol, laureth-7, hexyldecanol, fragrance


Questions Or Comments?



1-800-LANCOME (1-800-526-2663) Monday - Friday (9 a.m. - 5 p.m. EST)


Package Labeling:




* Please review the disclaimer below.