Label: PETER THOMAS ROTH CC LIGHT TO MEDIUM- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65278-007-15, 65278-007-16 - Packager: June Jacobs Laboratories LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 30, 2013
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
PETERTHOMASROTH
CLINICAL
SKIN
CARE30 × VITAMIN
OF AN ORANGE CCC
CREAM
broad spectrum
SPF 30COMPLEXION
CORRECTORanti-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 & wrinkles50 ML / 1.7 FL OZ
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INGREDIENTS AND APPEARANCE
PETER THOMAS ROTH CC LIGHT TO MEDIUM
titanium dioxide and zinc oxide lotionProduct 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)