NDC 11523-7094 Bain De Soleil Mega Tan Spf 4
Octinoxate And Octocrylene Lotion Topical

Product Information

Product Code11523-7094
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.
Bain De Soleil Mega Tan Spf 4
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.
Octinoxate 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.
Bayer Healthcare Llc.
Labeler Code11523
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
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.
05-21-1999
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.
12-31-2022
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

Usage Information


Product Characteristics

Color(s)WHITE (C48325 - OFF WHITE)

Product Packages

NDC 11523-7094-1

Package Description: 1 TUBE in 1 CARTON > 118 mL in 1 TUBE

Product Details

Bain De Soleil Mega Tan Spf 4 is a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Bain De Soleil Mega Tan Spf 4 is octinoxate and octocrylene. The product's dosage form is lotion and is administered via topical form.


What are Bain De Soleil Mega Tan Spf 4 Active Ingredients?

The following is the list of active ingredients in this product. 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.


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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
  • APRICOT (UNII: 269CJD5GZ9)
  • CHAMOMILE (UNII: FGL3685T2X)
  • COCOA (UNII: D9108TZ9KG)
  • PALM KERNEL OIL (UNII: B0S90M0233)
  • LANOLIN (UNII: 7EV65EAW6H)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • DIHYDROXYACETONE (UNII: O10DDW6JOO)


* Please review the disclaimer below.

Bain De Soleil Mega Tan Spf 4 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



Other



Drug Facts


Active Ingredient



Octinoxate 3.5%, Octocrylene 1%


Purpose



Sunscreen


Use



  • helps prevent sunburn

Skin Cancer/Skin Aging Alert



Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only


Otc - Do Not Use



Do not use on damaged or broken skin


Otc - When Using



When using this product keep out of eyes. Rinse with water to remove


Otc - Stop Use



Stop use and ask a doctor if rash occurs


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • use sparingly around hairline and eyebrows. Blend completely to avoid streaking. Wash and wipe hands immediately after each application

For Sunscreen Use



  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor

Other Information



  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics or surfaces
    • store at or below room temperature

Inactive Ingredients



water, butylene glycol, cyclopentasiloxane, polyquaternium-37, mineral oil, PPG-1 trideceth-6, VP/eicosene copolymer, isohexadecane, tribehenin, cetyl palmitate, fragrance, distearyldimonium chloride, aloe barbadensis leaf extract, eucalyptus globulus leaf extract, prunus armeniaca (apricot) fruit extract, chamomilla recutita (matricaria) flower extract, theobroma cacao (cocoa) extract, elaeis guineensis (palm) kernel oil, lanolin, iodopropynyl butylcarbamate, DMDM hydantoin, cetyl alcohol, cetyl hydroxyethylcellulose, disodium EDTA, dihydroxyacetone


Questions?



866-288-3330


Principal Display Panel - 118 Ml Tube Carton



BAIN
de
SOLEIL ®

MEGA TAN ®

4
spf

sunscreen with self tanner

faster, darker tan
contains a self tanner
moisturizers & botanicals

4 FL OZ (118mL)


* Please review the disclaimer below.