CLARITY RX - SKIN DEFENSE ENVIRONMENTAL PROTECTION- 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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Clarity Rx® - Skin Defense™ Environmental Protection

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 to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: 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:

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.

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 60 g Bottle Label

CLARITYRX®

5
SKIN DEFENSE™
Environmental Protection

Naturally Moisturizing
Broad-Spectrum Sunscreen SPF 30

Net Wt 2 oz / 60g

PRINCIPAL DISPLAY PANEL - 60 g Bottle Label
CLARITY RX - SKIN DEFENSE ENVIRONMENTAL PROTECTION 
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-6401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 g
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-6401-160 g 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: a2e9cdee-4209-45a7-a4c5-ae52d876d1f3
Set id: 9f52f409-ef6a-4787-b6d7-244d9047620b
Version: 1
Effective Time: 20190926
 
Cosmetic Solutions LLC