SOLEIL TOUJOURS SPF 15 SHEER SUNSCREEN- avobenzone, octisalate spray 
Prime Packaging 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 Toujours SPF 15 Sheer Sunscreen Mist

Active Ingredients

Avobenzone 3%, Homosalate 7.5%, Octisalate 5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120ºF. Do not use in the presence of a flame or spark, or while smoking.

Do not useon damaged or broken skin.

When using this product: Keep away from face to avoid breathing in • 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

Inactive ingredients

Artemesia Pallens Flower Oil, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citrus Aurantifolia Peel Oil, Citrus Aurantium Bergamia Fruit Extract, Citrus Limon Peel Oil, Citrus Nobilis Flower Oil, Citrus Sinensis Peel Oil, Cucumis Sativus (Cucumber) Extract, Ethyl Acetate, Ethyl Acetoacetate, Ferula Galbaniflua Resin Oil, Gamma Undecalactone, Glycerin, Heliotropine, Isoamyl Acetate, Isobutyl Acetate, Jasminum Sambac Oil, Opoponax Oil, Polyester-8, Porphyra Umbilicalis Extract, Salvia Sclarea Oil, SD Alcohol 40-B, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other information

Question or comments?

Call +1-877-320-2381 www.soleiltoujours.com

Soleil Toujours SPF 15 Sheer Sunscren Mist

Principal Display Label

SOLEIL TOUJOURS  SPF 15 SHEER SUNSCREEN
avobenzone, octisalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.52 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LEVOMENOL (UNII: 24WE03BX2T)  
GALBANUM OIL (UNII: 211UF7M8N1)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
OPOPANAX RESIN (UNII: TA8L57B94W)  
ORANGE OIL (UNII: AKN3KSD11B)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
DAVANA OIL (UNII: CL439Y041G)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
PIPERONAL (UNII: KE109YAK00)  
ISOBUTYL ACETATE (UNII: 7CR47FO6LF)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOAMYL ACETATE (UNII: Z135787824)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CUCUMBER JUICE (UNII: 61845009SP)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VINYL ACETATE (UNII: L9MK238N77)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
LEMON OIL (UNII: I9GRO824LL)  
LIME OIL (UNII: UZH29XGA8G)  
CITRUS NOBILIS (UNII: 8MFF77J91V)  
JASMINUM SAMBAC WHOLE (UNII: 1Z81V275I0)  
ETHYL ACETATE (UNII: 76845O8NMZ)  
Product Characteristics
Coloryellow (Colorless to Pale Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0133-4177 mL in 1 CAN; Type 0: Not a Combination Product04/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/13/2017
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0133) , analysis(13630-0133)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0133) , label(13630-0133)

Revised: 1/2020
Document Id: 9c5c9c48-c7cf-3665-e053-2995a90af9e3
Set id: 7809e933-9399-35eb-e053-2991aa0ac161
Version: 2
Effective Time: 20200117
 
Prime Packaging Inc.