Soleil Toujours Broad Spectrum SPF 30 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 30 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 Broad Spectrum SPF 30 Sheer Sunscreen Mist

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

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 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.

Flammable: Contents under pressure. Do not puncture or incinerate. Do not 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 minutes 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

Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Cucumis Sativus (Cucumber) Extract, Fragrance, Glycerin, Polyester-8, Porphyra Umbilicalis Extract, SD Alcohol 40-B, Sodium Hyaluronate, 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 30 Sheer Sunscreen Mist - 170 g

SOLEIL TOUJOURS  SPF 30 SHEER SUNSCREEN MIST
avobenzone, homosalate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
WATER (UNII: 059QF0KO0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
LEVOMENOL (UNII: 24WE03BX2T)

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: 13630-0185-3	85 g in 1 CAN; Type 0: Not a Combination Product	08/17/2016	10/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/17/2016	10/21/2022

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	analysis(13630-0185) , manufacture(13630-0185) , label(13630-0185) , pack(13630-0185)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0185) , label(13630-0185)

Revised: 10/2022

Document Id: eb890e14-9f35-812a-e053-2995a90a32f4

34390-5

Set id: cf591516-6ddc-dfe5-e053-2995a90a1c4e

Version: 2

Effective Time: 20221021