SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME- octinoxate, titanium dioxide cream

Soleil Broad Spectrum SPF 30 Sunscreen Body Creme by

Drug Labeling and Warnings

Soleil Broad Spectrum SPF 30 Sunscreen Body Creme by is a Otc medication manufactured, distributed, or labeled by Soleil Group, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Octinoxate 7.5%

Titanium Dioxide 3.5%

Purpose

Sunscreen

Uses:

Helps prevent sunburn
If used as directed with other sun protection measures (see), decreases the risk of skin cancer and early skin aging caused by the sun.

Inactive Ingredients:

A-bisabolol, algae extract, aloe barbadensis leaf (aloe vera gel) juice*, aqua (deionized water), camellia sinensis leaf (green tea) extract*, carthamus tinctorius (safflower) oil*, cetearyl alcohol, citrullus lanatus (watermelon) extract, citrus aurantifolia fruit oil, citrus aurantium dulcis peel oil, citrus limon peel oil, citrus reticulata leaf oil, commiphora myrrha resin oil, cyclomethicone, dimethicone, gluconolactone, glycerin*, helianthus annuus (sunflower) oil*, isopropyl palmitate, menthapiperita stem/leaf oil, mentha viridis leaf oil, microcrystalline wax, myristica fragrans kernel oil, pogostemon cablin oil, rosa damascena flower oil, salvia scalrea oil, santalum spicata wood oil, sdoium benzoate, tetrahexyldecyl ascorbate (vitamin C), thymus vulgaris oil, tocopherol acetate (vitamin E). *Organic 68.77%

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.

Directions:

Apply liberally 15 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 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

Other Information:

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

Questions or comments:

Call 917-338-7291

Product Label

INGREDIENTS AND APPEARANCE

SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69630-639
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATERMELON (UNII: 231473QB6R)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
ORANGE PEEL (UNII: TI9T76XD44)
MYRRH OIL (UNII: H74221J5J4)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PATCHOULI OIL (UNII: F3IN55X5PO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CASTOR OIL (UNII: D5340Y2I9G)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
SALVIA SCLAREA SEED OIL (UNII: JK0RP5O3HW)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
THYME OIL (UNII: 2UK410MY6B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69630-639-01	1 in 1 BOX	02/07/2017
1		120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/25/2015

Labeler - Soleil Group, LLC (079694651)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(69630-639)