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

----------

Soleil Broad Spectrum SPF 30 Sunscreen Body Creme

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

BoxLabel

SOLEIL BROAD SPECTRUM SPF 30 SUNSCREEN BODY CREME 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69630-639
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69630-639-011 in 1 BOX02/07/201702/07/2017
1120 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/25/201502/07/2017
Labeler - Soleil Group, LLC (079694651)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(69630-639)

Revised: 10/2023
 
Soleil Group, LLC