SOLEIL TOUJOURS BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate lotion 
Prime Enterprises Inc.

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.

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Soleil Toujors Makeup Setting Spray SPF 30 Broad Spectrum Sunscreen

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not us e 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.

Flammable: Do not use near heat,flame or while smoking.

Directions

Abies siberica Needle Oil, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citrus aurantifolia Fruit Oil, Citrus aurantium bergamia Fruit Extract, Citrus aurantium dulcis Peel Oil, Citrus grandis Peel Oil, Citrus limon Peel Oil, Citrus nobilis Peel Oil, Citrus reticulata Leaf Oil, Commiphora myrrha Resin Oil, Cucumis Sativus (Cucumber) Extract, Ethyl Vanillin, Eucalyptus globulus Leaf Oil, Ferula galbaniflua Oil, Glycerin, Juniperus virginiana Oil, Lavandula angustifolia Oil, Mentha piperita Stem/Leaf Oil, Mentha viridis Leaf Oil, Myristica fragrans Kernel Oil, Pelargonium graveolens Flower Oil, Pogostemon cablin Oil, Polyester-8, Porphyra Umbilicalis Extract, Rosa damascena Flower Oil, Salvia sclarea Oil, Santalum spicata Wood Oil, SD Alcohol 40-B, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Thymus vulgaris Oil, Tocopheryl Acetate, Triethyl Citrate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vanillin, Water

Other Information

Protect this product from excessive heat and direct sun.

Question or comments?

Call 1-877-320-2381

Soleil Toujours SPF 30 Makeup Setting Spray Sunscreen

Principle Display Label

SOLEIL TOUJOURS  BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0518
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.85 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.11 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE62.78 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE PEEL (UNII: TI9T76XD44)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATER (UNII: 059QF0KO0R)  
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
CITRUS NOBILIS (UNII: 8MFF77J91V)  
LEVOMENOL (UNII: 24WE03BX2T)  
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)  
SPEARMINT OIL (UNII: C3M81465G5)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
ALCOHOL (UNII: 3K9958V90M)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
VANILLIN (UNII: CHI530446X)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
THYME OIL (UNII: 2UK410MY6B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GALBANUM OIL (UNII: 211UF7M8N1)  
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MYRRH OIL (UNII: H74221J5J4)  
CUCUMBER (UNII: YY7C30VXJT)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
ABIES SIBIRICA WHOLE (UNII: 80YP21OD21)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
NUTMEG OIL (UNII: Z1CLM48948)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
Coloryellow (Very Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0518-350 mL in 1 TUBE; Type 0: Not a Combination Product08/30/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2016
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0518) , manufacture(58443-0518) , label(58443-0518) , analysis(58443-0518)

Revised: 1/2022
Document Id: d5c9d527-4d72-662f-e053-2a95a90af07c
Set id: d5c9d5fc-cbac-5224-e053-2a95a90ae568
Version: 1
Effective Time: 20220117
 
Prime Enterprises Inc.