SOLEIL TOUJOURS SPF 15 SHEER SUNSCREEN- avobenzone, 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 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

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 apply liberally 15 minutes before sun exposure
• 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

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

• 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 15 Sheer Sunscren Mist

INGREDIENTS AND APPEARANCE

SOLEIL TOUJOURS  SPF 15 SHEER SUNSCREEN
avobenzone, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	16.52 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (Colorless to Pale Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0133-4	177 mL in 1 CAN; Type 0: Not a Combination Product	04/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/13/2017

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0133) , analysis(13630-0133)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0133) , label(13630-0133)