SOLEIL FORTE MULTI

Manufacturer
LINEX HEALTH & BEAUTY
Effective date
2022-12-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:52:43

Label at a glance#

ProductSOLEIL FORTE MULTI
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure9 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 7.5%

OCTISALATE 5%

HOMOSALATE 5%

AVOBENZONE 3%

OCTOCRYLENE 2.75%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOLEIL BOXSOLEIL BOX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69769-101-11SOLEIL FORTE MULTI50 mL in 1 TUBELOTION505
69769-101-51SOLEIL FORTE MULTI1 in 1 BOXLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69769-101SOLEIL FORTE MULTI (OCTINOXATE, OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE) LOTION [LINEX HEALTH & BEAUTY]5Legacy NDC, 2 package rows20221230_14798d58-d3e8-0272-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
HOMOSALATEACTIVE INGREDIENTV06SV4M95S2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
HOMOSALATEACTIVE MOIETYV06SV4M95S2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2
.ALPHA.,.BETA.'-DIGLYCERININACTIVE INGREDIENTLG6U99J4V12
1,3-BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
ALUMINUM STEARATESINACTIVE INGREDIENTO4D7U3B46U2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CETEARYL ISONONANOATEINACTIVE INGREDIENTP5O01U99NI2
CETYL RICINOLEATEINACTIVE INGREDIENT1P677500YD2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)INACTIVE INGREDIENTUF7620L1W62
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C52
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
GINKGO BILOBA WHOLEINACTIVE INGREDIENT660486U6OI2
GLYCERYL CAPRATEINACTIVE INGREDIENT197M6VFC1W2
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H2
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J2
HYDROGENATED JOJOBA OIL, RANDOMIZEDINACTIVE INGREDIENTQ47ST02F582
LYCIUM BARBARUM FRUITINACTIVE INGREDIENT930626MWDL2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
METHYL METHACRYLATEINACTIVE INGREDIENT196OC776882
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM02
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLY(METHYL METHACRYLATE; 450000 MW)INACTIVE INGREDIENTZ47NNT4J112
POLYGLYCEROL POLYRICINOLEIC ACIDINACTIVE INGREDIENT3C96Y1D5T42
POLYMETHYLSILSESQUIOXANE (11 MICRONS)INACTIVE INGREDIENTZ570VEV8XK2
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0W2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5A2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
WATERINACTIVE INGREDIENT059QF0KO0R2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69769-10169769-101-11, 69769-101-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 211 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
134 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOAP / TOPICAL1.26 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER / TOPICALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
1,3-BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAPERITONEAL0.54 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ENDOTRACHEAL7.6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / ORAL148 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RESPIRATORY (INHALATION)108 mgExact identifier — unii candidate
134 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WCREAM / VAGINAL50 mgExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR45 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XENEMA / RECTAL0.7 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERINEURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / VAGINAL10 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET / SUBLINGUAL2 mgExact identifier — unii candidate
7 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INFILTRATION3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRASYNOVIAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f0ff1932-36b0-200e-e053-2a95a90a689514798d58-d3e8-0272-e054-00144ff8d46c2022-12-29WarningsExact identifier
spl id: f0ff1932-36b0-200e-e053-2a95a90a6895
spl set id: 14798d58-d3e8-0272-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.