Peter Thomas Roth Cc
FDA Label NDC 65278-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by June Jacobs Laboratories Llc for the product Peter Thomas Roth Cc (NDC 65278-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active IngredientsPurpose
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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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)

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)

Principal Display Panel (50 mL Bottle Label)

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