Bain de Soleil ® Mega Tan ® SPF 4

Bain de Soleil ® Mega Tan ® SPF 4

Drug Labeling and Warnings

Drug Details

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BAIN DE SOLEIL MEGA TAN SPF 4- octinoxate and octocrylene lotion 
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bain de Soleil ®

Mega Tan ® SPF 4

Drug Facts

Active ingredient

Octinoxate 3.5%, Octocrylene 1%

Purpose

Sunscreen

Use

  • helps prevent sunburn

Warnings

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

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 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
BAIN DE SOLEIL  MEGA TAN SPF 4
octinoxate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7094
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE35 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
Colorwhite (off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7094-11 in 1 CARTON05/21/1999
1118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/21/1999
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2017
 
Bayer HealthCare LLC.


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