Bain De Soleil
FDA Label NDC 11523-7094

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Bain De Soleil (NDC 11523-7094). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, skin cancer/skin aging alert, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (118 mL Tube Carton)

Principal Display Panel (118 mL Tube Carton)

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