OTC Medication Information: Soleil Toujours SPF 50 Sheer Sunscreen Mist

SOLEIL TOUJOURS SPF 50 SHEER SUNSCREEN MIST- avobenzone, homosalate and 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.

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

Principle Display Label
(click image for full-size original)

SOLEIL TOUJOURS SPF 50 SHEER SUNSCREEN MIST
avobenzone, homosalate, octisalate spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 25.17 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 62.93 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 41.95 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
TETRAHEXYLDECYL ASCORBATE
PORPHYRA UMBILICALIS
WATER
ASCORBYL PALMITATE
HYALURONATE SODIUM
ALOE VERA LEAF
CUCUMBER
GLYCERIN
GREEN TEA LEAF
.ALPHA.-TOCOPHEROL ACETATE
ALCOHOL
LEVOMENOL
Product Characteristics
Color yellow (Light Yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13630-0116-4 177 mL in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M020 08/17/2016 08/31/2023
Labeler — Prime Packaging Inc. (805987059)
Registrant — Prime Packaging Inc. (805987059)
Establishment
Name Address ID/FEI Operations
Prime Enterprises Inc 101946028 analysis (13630-0116), manufacture (13630-0116), label (13630-0116), pack (13630-0116)
Establishment
Name Address ID/FEI Operations
Prime Packaging Inc. 805987059 pack (13630-0116), label (13630-0116)

Revised: 06/2022 Prime Packaging Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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