CLE DE PEAU BEAUTE LONG-LASTING HYDRATING VEIL- avobenzone, octinoxate, and octocrylene emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

Available from:

SHISEIDO AMERICAS CORPORATION

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

CLE DE PEAU BEAUTE LONG-LASTING HYDRATING VEIL- AVOBENZONE,
OCTINOXATE, AND
OCTOCRYLENE EMULSION
SHISEIDO AMERICAS CORPORATION
_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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CLÉ DE PEAU BEAUTÉ LONG-LASTING HYDRATING VEIL
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
AVOBENZONE 2.5%
Sunscreen
OCTINOXATE 7.4%
Sunscreen
OCTOCRYLENE 2.0%
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.
FLAMMABLE: Do not use near heat, flame, or while smoking.
DIRECTIONS
For sunscreen use:
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every two 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
WATER▪SD ALCOHOL 40-B▪BUTYLENE
GLYCOL▪GLYCERIN▪DIMETHICONE▪TALC▪METHYL METHACRYLATE
CROSSPOLYMER▪BARIUM SULFATE▪PEG/PPG-19/19
DIMETHICONE▪HYDROGENATED
POLYISOBUTENE▪ERYTHRITOL▪XYLITOL▪TREHALOSE▪ARGANIA SPINOSA
KERNEL
OIL▪XANTHAN GUM▪POLYQUATERNIUM-51▪GLYCINE▪PEG/PPG-14/7
DIMETHYL
ETHER▪TRIMETHYLSILOXYSILICATE▪ROSA ROXBURGHII FRUIT
EXTRACT▪ANGELICA
ACUTILOBA ROOT EXTRACT▪HY