SOLEIL FORTE MULTI- octinoxate, octisalate, homosalate, avobenzone, octocrylene lotion 
LINEX HEALTH & BEAUTY

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.

----------

Linex (as PLD) - SOLEIL FORTE MULTI (67969-101)

ACTIVE INGREDIENT

OCTINOXATE 7.5%

OCTISALATE 5%

HOMOSALATE 5%

AVOBENZONE 3%

OCTOCRYLENE 2.75%

PURPOSE

SUNSCREEN

USES

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. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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.

SOLEIL BOX

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)

Revised: 12/2022
Document Id: f0ff1932-36b0-200e-e053-2a95a90a6895
Set id: 14798d58-d3e8-0272-e054-00144ff8d46c
Version: 5
Effective Time: 20221229
 
LINEX HEALTH & BEAUTY