CALMING PERFECTOR SPF 20 SUNSCREEN- titanium dioxide and zinc oxide liquid

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:

Colorescience

INN (International Name):

Titanium Dioxide

Composition:

Titanium Dioxide 54 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 not final

Summary of Product characteristics

CALMING PERFECTOR SPF 20 SUNSCREEN- TITANIUM DIOXIDE AND ZINC OXIDE
LIQUID
COLORES CIENCE
_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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CALMING PERFECTOR SPF 20 SUNSCREEN
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Titanium Dioxide 5.4%
Sunscreen
Zinc Oxide 5.4%
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 swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
Apply liberally 15 minutes before sun exposure. Works best on
moisturized skin.
Reapply:
After 40 minutes of swimming or sweating.
Immediately after towel drying.
At least every 2 hours.
Children under 6 months: ask a doctor.
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 value 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-sleeved shirts, pants, hats, and sunglasses.
INACTIVE INGREDIENTS
Cyclopentasiloxane, Caprylic/Capric Triglyceride, Dimethicone
Crosspolymer, Glycerin, Water,
Dimethicone/Vinyl Dimethicone Crosspolymer, Cucumis Sativus (Cucumber)
Fruit Extract, Spirulina
Maxima Extract, Camellia Sinensis Leaf Extract, Opuntia Ficus-Indica
Stem Extract, Palmaria Palmata
Extract, Disodium Lauriminodipropionate Tocopheryl Phosphates, Citrus
Paradisi (Grapefruit) Seed
Extract, Ascorbic Acid, Dimethiconol, Dimethicone,
Triethoxycaprylylsilane, Benzoic Acid,
Dehydroacetic Acid, Phenoxyethanol, Iro