PREP (AND) PRIME CC COLOR CORRECT SPF30 BROAD SPECTRUM- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cre

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

MAKEUP ART COSMETICS

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 0.08175 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

helps prevent sunburn

Authorization status:

OTC monograph not final

Summary of Product characteristics

PREP (AND) PRIME CC COLOR CORRECT SPF30 BROAD SPECTRUM- OCTINOXATE,
OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE CREAM
MAKEUP ART COSMETICS
_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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PREP (AND) PRIME CC COLOR CORRECT SPF30 BROAD SPECTRUM
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Octinoxate 7.40%
Sunscreen
Octisalate 4.00%
Sunscreen
Zinc Oxide 3.30%
Sunscreen
Oxybenzone 2.50%
Sunscreen
Titanium Dioxide 1.10%
Sunscreen
US E
helps prevent sunburn
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
For sunscreen use:
apply liberally 15 minutes before sun exposure
reapply every two hours
use a water resistant sunscreen if swimming or sweating
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
children under 6 months of age: ask a doctor
INACTIVE INGREDIENTS
water\aqua\eau, dimethicone, butylene glycol, phenyl trimethicone,
pentylene glycol, glyceryl stearate,
behenyl alcohol, trioctyldodecyl citrate, polymethylsilsesquioxane,
octyldodecyl stearoyl stearate,
peg-40 stearate, polyglyceryl-10 pentastearate, tocopheryl acetate,
sodium hyaluronate, lecithin,
squalane, hordeum vulgare (barley) extract\extrait d'orge, triticum
vulgare (wheat) germ extract,
laminaria saccharina extract, cucumis sativus (cucumber) fruit
extract, pyrus malus (apple) fruit extract,
scutellaria baicalensis