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

SOLEIL FORTE MULTI by

Drug Labeling and Warnings

SOLEIL FORTE MULTI by is a Otc medication manufactured, distributed, or labeled by LINEX HEALTH & BEAUTY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SOLEIL FORTE MULTI 
octinoxate, octisalate, homosalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69769-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69769-101-51	1 in 1 BOX	04/24/2015
1	NDC: 69769-101-11	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/24/2015

Labeler - LINEX HEALTH & BEAUTY (050219996)

Registrant - LINEX HEALTH & BEAUTY (050219996)

Establishment
Name	Address	ID/FEI	Business Operations
FMK LABS, INC.		046383819	manufacture(69769-101)