Label: BAIN DE SOLEIL MEGA TAN SPF 4- octinoxate and octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 8, 2023

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  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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 CARTON05/21/199904/30/2021
    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)
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