SOLEIL TOUJOURS BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate lotion

Soleil Toujours by

Drug Labeling and Warnings

Soleil Toujours by is a Otc medication manufactured, distributed, or labeled by 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 us e 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 away from face to avoid breathing it, Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120ºF.

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 before use
• with your eyes completely closed, mist face evenly, holding bottle 10-12 inches away from face. Do not breathe mist in. Allow to fully dry.
• apply liberally 15 minutes before sun exposure
• 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 broad spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

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

Other Information

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

Question or comments?

Call 1-877-320-2381

Soleil Toujours Set + Protect Micro Mist Broad Spectrum SPF 30 SPF 30 Sunscreen

INGREDIENTS AND APPEARANCE

SOLEIL TOUJOURS  BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.3 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24.78 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	24.78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BERGAMOT OIL (UNII: 39W1PKE3JI)
ORANGE PEEL (UNII: TI9T76XD44)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
CITRUS NOBILIS (UNII: 8MFF77J91V)
LEVOMENOL (UNII: 24WE03BX2T)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
SPEARMINT OIL (UNII: C3M81465G5)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
ALCOHOL (UNII: 3K9958V90M)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
VANILLIN (UNII: CHI530446X)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
THYME OIL (UNII: 2UK410MY6B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GALBANUM OIL (UNII: 211UF7M8N1)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MYRRH OIL (UNII: H74221J5J4)
CUCUMBER (UNII: YY7C30VXJT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ABIES SIBIRICA WHOLE (UNII: 80YP21OD21)
ETHYL VANILLIN (UNII: YC9ST449YJ)
NUTMEG OIL (UNII: Z1CLM48948)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0555-3	59 mL in 1 TUBE; Type 0: Not a Combination Product	02/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/20/2017

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0555) , manufacture(58443-0555) , label(58443-0555) , analysis(58443-0555)