Label: SOLEIL FORTE MULTI- octinoxate, octisalate, homosalate, avobenzone, octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 29, 2022

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  • ACTIVE INGREDIENT

    OCTINOXATE 7.5%

    OCTISALATE 5%

    HOMOSALATE 5%

    AVOBENZONE 3%

    OCTOCRYLENE 2.75%

  • 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

    KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • APPLY LIBERALLY BEFORE 15 MINUTES SUN EXPOSURE.
    • REAPPLY
    • AFTER 40 MINUTES OF SWIMMING
    • AT LEAST EVERY 2 HOURS
    • CHILDREN UNDER 6 MONTHS; ASK A DOCTOR.
  • OTHER INFORMATION

    PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

  • INACTIVE INGREDIENTS

    WATER, CYCLOPENTASILOXANE, GLYCERIN, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, DIMETHICONE, CETEARYL ISONONANOATE, METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYGLYCERYL-3 POLYRICINOLEATE, ACRYLATES/DIMETHICONE COPOLYMER, SODIUM CHLORIDE, GINKGO BILOBA LEAF EXTRACT, JOJOBA ESTERS, ALOE BARBADENSIS LEAF JUICE, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, BUTYLENE GLYCOL, SORBITAN SESQUIOLEATE, CETYL RICINOLEATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, GLYCERYL CAPRATE, MAGNESIUM STEARATE, ALUMINUM TRISTEARATE, SILICA SILYLATE, HEXYLENE GLYCOL, TOCOPHEROL, BEESWAX, VINYL DIMETHICONE/METHICONE SESQUIOXANE CROSSPOLYMER, LYCIUM BARBARUM FRUIT EXTRACT, FRAGRANCE.

  • PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    SOLEIL BOX

  • INGREDIENTS AND APPEARANCE
    SOLEIL FORTE MULTI 
    octinoxate, octisalate, homosalate, avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69769-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.,.BETA.'-DIGLYCERIN (UNII: LG6U99J4V1)  
    POLYGLYCEROL POLYRICINOLEIC ACID (UNII: 3C96Y1D5T4)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    CETYL RICINOLEATE (UNII: 1P677500YD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ALUMINUM STEARATES (UNII: O4D7U3B46U)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69769-101-511 in 1 BOX04/24/2015
    1NDC:69769-101-1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/24/2015
    Labeler - LINEX HEALTH & BEAUTY (050219996)
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