PROFESSIONAL SOLUTIONS TINTED MOISTURIZER SPF 30 LIGHT- octinoxate and zinc oxide cream 
PROFESSIONAL SOLUTIONS TINTED MOISTURIZER SPF 30 MEDIUM- octinoxate and zinc oxide cream 
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® Tinted Moisturizer SPF 30

DRUG FACTS:

ACTIVE INGREDIENTS

Octyl Methoxycinnamate 7.5%, Zinc Oxide 7.0%

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), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone , Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate,C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethyhexylglycerin, Polyacrylamide, Iron Oxides (Cl77491), (Cl77492) (Cl77499).

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 - 50 mL Bottle Label - Light

Professional
Solutions®
PURE SCIENCE. BETTER SKIN

tinted moisturizer
sunscreen
broad spectrum
spf30 - light

protects + moisturizes

1.75 Fl. Oz. (50mL)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label - Light

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label - Medium

Professional
Solutions®
PURE SCIENCE. BETTER SKIN

tinted moisturizer
sunscreen
broad spectrum
spf30 - medium

protects + moisturizes

1.75 Fl. Oz. (50mL)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label - Medium
PROFESSIONAL SOLUTIONS TINTED MOISTURIZER SPF 30 LIGHT 
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-7610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Glyceryl Dilaurate (UNII: MFL3ZIE8SK)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Dimethicone (UNII: 92RU3N3Y1O)  
Cyclomethicone (UNII: NMQ347994Z)  
Diisopropyl Adipate (UNII: P7E6YFV72X)  
Hexylene Glycol (UNII: KEH0A3F75J)  
PEG-40 Stearate (UNII: ECU18C66Q7)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
Carnauba Wax (UNII: R12CBM0EIZ)  
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
Sorbitan Tristearate (UNII: 6LUM696811)  
Stearoxytrimethylsilane (UNII: 9862TW94B2)  
Steareth-100 (UNII: 4OH5W9UM87)  
Laureth-7 (UNII: Z95S6G8201)  
C13-14 Isoparaffin (UNII: E4F12ROE70)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-7610-250 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
PROFESSIONAL SOLUTIONS TINTED MOISTURIZER SPF 30 MEDIUM 
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-7620
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Glyceryl Dilaurate (UNII: MFL3ZIE8SK)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Dimethicone (UNII: 92RU3N3Y1O)  
Cyclomethicone (UNII: NMQ347994Z)  
Diisopropyl Adipate (UNII: P7E6YFV72X)  
Hexylene Glycol (UNII: KEH0A3F75J)  
PEG-40 Stearate (UNII: ECU18C66Q7)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
Carnauba Wax (UNII: R12CBM0EIZ)  
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
Sorbitan Tristearate (UNII: 6LUM696811)  
Stearoxytrimethylsilane (UNII: 9862TW94B2)  
Steareth-100 (UNII: 4OH5W9UM87)  
Laureth-7 (UNII: Z95S6G8201)  
C13-14 Isoparaffin (UNII: E4F12ROE70)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-7620-250 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: 099ed598-5432-4ad5-987f-78d0f6616c37
Set id: 09c81d8f-5c6c-4f3d-a3d3-a964a99cdeab
Version: 1
Effective Time: 20190925
 
Cosmetic Solutions LLC