PETER THOMAS ROTH CC LIGHT TO MEDIUM- titanium dioxide and zinc oxide lotion

Peter Thomas Roth CC by

Drug Labeling and Warnings

Peter Thomas Roth CC by is a Otc medication manufactured, distributed, or labeled by June Jacobs Laboratories LLC, Cosmecca Korea Co. LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 10.26%	Sunscreen
Zinc Oxide 5.76%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 involved in swimming or intense physical activities where sweating will occur
• reapply at least every 2 hours
• 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

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

• protect this product from excessive heat and direct sun

Questions or comments?

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PETER THOMAS ROTH CC  LIGHT TO MEDIUM
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65278-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	102.6 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	57.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65278-007-15	1 in 1 CARTON
1		50 mL in 1 TUBE
2	NDC: 65278-007-16	15 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/22/2013

Labeler - June Jacobs Laboratories LLC (082439410)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co. LTD		688830827	MANUFACTURE(65278-007)