PROFESSIONAL SOLUTIONS SUNCREEN SPF 30- octinoxate and titanium dioxide lotion 
Cosmetic Solutions LLC

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.

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Professional Solutions® Suncreen SPF 30

DRUG FACTS:

ACTIVE INGREDIENTS

Octinoxate 7%

Titanium Dioxide 2.5%

PURPOSE

Sunscreen

USES

Helps prevent sunburn.

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 generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen.

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:

INACTIVE INGREDIENTS

Water (Aqua), Aloe Barbadensis Leaf Extract, Isocetyl Stearate, Sorbitol, Cetearyl Alcohol, Ceteareth-20, Tocopheryl Acetate, Acetyl Hexapeptide-8, Hydrolyzed Rice Protein, Alcohol SDA-40, Dimethicone, Octyl Salicylate, Cetyl Alcohol, Sodium Laureth Sulfate, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Fragrance, Triethanolamine, Triethoxycaprylylsilane, Lecithin, Caprylyl Glycol, Methylisothiazolinone.

OTHER INFORMATION

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

Manufactured By:
Professional Solutions
Boca Raton, FL 33487

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

Professional
Solutions®
PURE SCIENCE. BETTER SKIN

sunscreen lotion
broad spectrum spf 30
water resistant (40 mins)

protects + moisturizes

2 Fl. Oz. (60mL)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
PROFESSIONAL SOLUTIONS SUNCREEN SPF 30 
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-6500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Isocetyl Stearate (UNII: 3RJ7186O9W)  
Sorbitol (UNII: 506T60A25R)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)  
Dimethicone (UNII: 92RU3N3Y1O)  
Octisalate (UNII: 4X49Y0596W)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Methicone (20 Cst) (UNII: 6777U11MKT)  
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
Carboxypolymethylene (UNII: 0A5MM307FC)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Trolamine (UNII: 9O3K93S3TK)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Aluminum Oxide (UNII: LMI26O6933)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-6500-260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2019
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 9/2019
Document Id: b79614cf-044e-4c79-8c00-343dbef0b338
Set id: cb8dfbf0-142f-4579-b906-94c0925522d7
Version: 1
Effective Time: 20190925
 
Cosmetic Solutions LLC