CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING- avobenzone, octinoxate, octocrylene, and oxybenzone cream

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), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Available from:

SHISEIDO AMERICAS CORPORATION

INN (International Name):

AVOBENZONE

Composition:

AVOBENZONE 1020 mg in 50 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

CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING- AVOBENZONE, OCTINOXATE,
OCTOCRYLENE,
AND OXYBENZONE CREAM
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 PROTECTIVE FORTIFYING
CREAM
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
AVOBENZONE 2.0%
Sunscreen
OCTINOXATE 4.9%
Sunscreen
OCTOCRYLENE 5.0%
Sunscreen
OXYBENZONE 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.
DIRECTIONS
For sunscreen use:
apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
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
WATER (AQUA/EAU)·CYCLOMETHICONE·GLYCERIN·DIISOPROPYL
SEBACATE·BUTYLENE
GLYCOL·DIETHYLHEXYL SUCCINATE·SD ALCOHOL 40-B·PEG/PPG-14/7 DIMETHYL
ETHER·TREHALOSE·DIMETHICONE/VINYL DIMETHICONE
CROSSPOLYMER·TOCOPHERYL
ACETATE·PEG/PPG-17/4 DIMETHYL ETHER·PHYTOSTERYL
MACADAMIATE·POLYQUATERNIUM-51·SODIUM ACETYLATED HYALURONATE·GINKGO
BILOBA LEAF EXTRACT·PAEONIA ALBIFLORA ROOT EXTRACT·CRATAEGUS
MONOGYNA FLOWER EXTRACT·CAFFEINE·SERINE·HYDR