PETER THOMAS ROTH CC LIGHT TO MEDIUM- titanium dioxide and zinc oxide lotion 
June Jacobs Laboratories 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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Peter Thomas Roth CC Cream - Light/Medium

Drug Facts

Active IngredientsPurpose
Titanium Dioxide 10.26% Sunscreen
Zinc Oxide 5.76%Sunscreen

Uses

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

Inactive Ingredients

Alcohol, Aluminum Hydroxide, Arbutin, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Calcium Stearate, Caprylyl Glycol, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipropylene Glycol, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, 1,2-Hexanediol, Hexyl Laurate, Hydrolyzed Collagen, Iron Oxides (CI 77491, CI 77492, CI 77499), Magnesium Sulfate, Mica, Myrciaria Dubia Fruit Extract, PEG-10 Dimethicone, Phenoxyethanol, Phenyl Trimethicone, Polysorbate 80, Propylene Carbonate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water.

Other Information

Questions or comments?

Call toll free 1-800-PTR-SKIN (787-7546)

Dist. by: ©PETERTHOMASROTH® Labs LLC
New York New York 10022

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PETERTHOMASROTH

CLINICAL
SKIN
CARE

30 × VITAMIN
OF AN ORANGE C

CC
CREAM
broad spectrum
SPF 30

COMPLEXION
CORRECTOR

anti-aging
sunscreen
complexion
corrector &
tint in one
help
protect
brighten &
moisturize
camu camu &
arbutin
help
improve
the appearance of
uneven skin tone
imperfections
fine lines & wrinkles

50 ML / 1.7 FL OZ

Principal Display Panel - 50 mL Bottle Label
PETER THOMAS ROTH CC  LIGHT TO MEDIUM
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65278-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide102.6 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide57.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Glycerin (UNII: PDC6A3C0OX)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Dipropylene Glycol (UNII: E107L85C40)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Dimethicone (UNII: 92RU3N3Y1O)  
Arbutin (UNII: C5INA23HXF)  
Butylene Glycol Dicaprylate/Dicaprate (UNII: 75D21FL1PI)  
Hexyl Laurate (UNII: 4CG9F9W01Q)  
Magnesium Sulfate (UNII: DE08037SAB)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Calcium Stearate (UNII: 776XM7047L)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Propylene Carbonate (UNII: 8D08K3S51E)  
Ethylhexylglycerin (UNII: 147D247K3P)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Edetate Disodium (UNII: 7FLD91C86K)  
Myrciaria Dubia Fruit (UNII: YSW4EM1EKP)  
Alcohol (UNII: 3K9958V90M)  
Mica (UNII: V8A1AW0880)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65278-007-151 in 1 CARTON
150 mL in 1 TUBE
2NDC:65278-007-1615 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35202/22/2013
Labeler - June Jacobs Laboratories LLC (082439410)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co. LTD688830827MANUFACTURE(65278-007)

Revised: 1/2013
Document Id: 318b93ed-05e9-4e0a-868a-f421e173bfc4
Set id: af230c73-121f-48fb-87d6-9f04c8066140
Version: 1
Effective Time: 20130130
 
June Jacobs Laboratories LLC