SOLEIL TOUJOURS BROAD SPECTRUM SPF 50 SET PROTECT MICRO 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 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 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.

INACTIVE INGREDIENT

Abies Siberica Needle Oil, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citrus Aurantifolia Fruit Oil, Citrus Aurantium Bergamia Fruit Extract, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Limon Peel Oil, Citrus Nobilis Peel Oil, Citrus Reticulata Leaf Oil, Commiphora Myrrha Resin Oil, Cucumis Sativus (Cucumber) Extract, Ethyl Vanillin, Eucalyptus Globulus Leaf Oil, Ferula Galbaniflua Oil, Glycerin, Juniperus Virginiana Oil, Lavandula, Angustifolia Oil, Mentha Piperita Stem/Leaf Oil, Mentha viridis Leaf Oil, Myristica Fragrans Kernel Oil, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Polyester-8, Porphyra Umbilicalis Extract, Rosa Damascena Flower Oil, Salvia Sclarea Oil, Santalum Spicata Wood Oil, SD Alcohol 40-B, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Thymus Vulgaris Oil, Tocopheryl Acetate, Triethyl Citrate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vanillin, Water

Directions

• Shake well
• Close eyes completely, then mist on face evenly, holding bottle 10 - 12 inches away from face. Do not breathe mist in. Wait until dry.
• Apply liberally 20 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply:
• Immediately after swimming, sweating or towel drying
• At least every 2 hours
• Children under 6 months: Ask a doctor.
• 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

Other Information

Protect the product in this container from excessive heat and direct sunlight.

Question or comments?

Call 1-877-320-2381

www.soleiltoujours.com

Soleil Toujours Broad Spectrum SPF 30 Set Protect Micro Mist

INGREDIENTS AND APPEARANCE

SOLEIL TOUJOURS  BROAD SPECTRUM SPF 50 SET PROTECT MICRO MIST
avobenzone, homosalate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.17 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	62.93 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.95 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
NUTMEG OIL (UNII: Z1CLM48948)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
SPEARMINT OIL (UNII: C3M81465G5)
THYME OIL (UNII: 2UK410MY6B)
VANILLIN (UNII: CHI530446X)
ABIES SIBIRICA WHOLE (UNII: 80YP21OD21)
PEPPERMINT OIL (UNII: AV092KU4JH)
PATCHOULI OIL (UNII: F3IN55X5PO)
LEMON OIL (UNII: I9GRO824LL)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GALBANUM OIL (UNII: 211UF7M8N1)
TRICAPRYLIN (UNII: 6P92858988)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
CITRUS MAXIMA SEED OIL (UNII: Z0829C95PX)
MANDARIN OIL (UNII: NJO720F72R)
MYRRH OIL (UNII: H74221J5J4)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYL VANILLIN (UNII: YC9ST449YJ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
LEVOMENOL (UNII: 24WE03BX2T)
BERGAMOT OIL (UNII: 39W1PKE3JI)
GLYCERIN (UNII: PDC6A3C0OX)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0117-3	60 mL in 1 CAN; Type 0: Not a Combination Product	08/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/30/2016

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0117) , analysis(13630-0117)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0117) , label(13630-0117)