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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP), Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)

Available from:

June Jacobs Laboratories LLC

INN (International Name):

Titanium Dioxide

Composition:

Titanium Dioxide 102.6 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- 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

Authorization status:

OTC monograph final

Summary of Product characteristics

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 INGREDIENTS
PURPOS E
Titanium Dioxide 10.26%
Sunscreen
Zinc Oxide 5.76%
Sunscreen
US ES
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, Phenox