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

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]

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

Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

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

• 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
• 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

INACTIVE INGREDIENT

Artemesia pallens Flower Oil, 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, 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, Tetrahexyldecyl Ascorbate, Tocopherol, 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

Soleil Toujours SPF 50 Sheer Sunscreen Mist

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.8 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	86.1 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	43.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
OPOPANAX RESIN (UNII: TA8L57B94W)
LEVOMENOL (UNII: 24WE03BX2T)
BERGAMOT OIL (UNII: 39W1PKE3JI)
PIPERONAL (UNII: KE109YAK00)
ISOAMYL ACETATE (UNII: Z135787824)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
WATER (UNII: 059QF0KO0R)
DAVANA OIL (UNII: CL439Y041G)
LEMON OIL (UNII: I9GRO824LL)
LIME OIL (UNII: UZH29XGA8G)
CITRUS NOBILIS WHOLE (UNII: U29I7N5FLM)
ETHYL ACETOACETATE (UNII: IZP61H3TB1)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
ETHYL ACETATE (UNII: 76845O8NMZ)
ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)
GALBANUM OIL (UNII: 211UF7M8N1)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TRICAPRYLIN (UNII: 6P92858988)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
TOCOPHEROL (UNII: R0ZB2556P8)
JASMINUM SAMBAC WHOLE (UNII: 1Z81V275I0)
ISOBUTYL ACETATE (UNII: 7CR47FO6LF)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0115-4	177 mL in 1 CAN; Type 0: Not a Combination Product	08/17/2016

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

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0115) , analysis(13630-0115)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0115) , label(13630-0115)