Soleil Toujours SPF 50 Sheer Sunscreen Mist

Soleil Toujours by

Drug Labeling and Warnings

Soleil Toujours by is a Otc medication manufactured, distributed, or labeled by Prime Packaging Inc., Prime Enterprises Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOLEIL TOUJOURS SPF 50 SHEER SUNSCREEN- 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.

----------

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.

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

• Shake well
• Hold container 4 to 6 inches from skin to apply.
• Apply liberally 15 minutes before sun exposure
• Do not spray directly into face
• Reapply:
• after 80 minutes of swimming and 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.

Other information

• Protect this product from excessive heat and direct sun. Avoid spraying on fabrics - could cause discoloration.

Inactive ingredients

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

Question or comments?

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

Soleil Toujours SPF 50 Sheer Sunscren Mist

SOLEIL TOUJOURS  SPF 50 SHEER SUNSCREEN
avobenzone, homosalate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.2 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	84 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
LEVOMENOL (UNII: 24WE03BX2T)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0209-4	202 mL in 1 CAN; Type 0: Not a Combination Product	04/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/26/2021

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0209) , analysis(13630-0209)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0209) , label(13630-0209)

Revised: 1/2022

Document Id: d5df10bc-16ff-7a97-e053-2a95a90ab15e

34390-5

Set id: d5df1a46-08a1-2889-e053-2a95a90a6a0b

Version: 1

Effective Time: 20220118