SOLEIL TOUJOURS SPF 50 SHEER SUNSCREEN MIST- avobenzone, homosalate, 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 50 Sheer Sunscreen Mist

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

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. Keep away from face to avoid breathing it.

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: Contents under pressure. Do not puncture or incinerate. Do no store at temperatures above 120°F. Do not use in the presence of a flame or spark, or while smoking.

Directions

  • Shake well
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • apply liberally 15 minutues before sun exposure
  • do not spray directly into face. Spray on hands then apply to face
  • do not apply in windy conditions
  • use in a well-ventilated area
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a. m. - 2 p. m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Fragrance, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water

Other Information

  • protect this product from excessive heat and direct sun
  • avoid spraying on fabrics - could cause discoloration

Question or comments?

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

Soleil Toujours SPF 50 Sheer Sunscreen Mist

Principle Display Label

SOLEIL TOUJOURS  SPF 50 SHEER SUNSCREEN MIST
avobenzone, homosalate, octisalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.8 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE86.1 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALCOHOL (UNII: 3K9958V90M)  
LEVOMENOL (UNII: 24WE03BX2T)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0115-4177 mL in 1 CAN; Type 0: Not a Combination Product08/17/201610/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/17/201610/31/2022
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0115) , analysis(13630-0115)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0115) , label(13630-0115)

Revised: 6/2022
 
Prime Packaging Inc.