CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT- avobenzone, octinoxate, octocrylene, and oxybenzone stick

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 100 mg in 4 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps prevent sunburn

Authorization status:

OTC monograph not final

Summary of Product characteristics

CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT- AVOBENZONE,
OCTINOXATE,
OCTOCRYLENE, AND OXYBENZONE STICK
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 UV PROTECTIVE LIP TREATMENT
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
AVOBENZONE 2.5%
Sunscreen
OCTINOXATE 4.9%
Sunscreen
OCTOCRYLENE 3.0%
Sunscreen
OXYBENZONE 2.0%
Sunscreen
US ES
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
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
DIISOSTEARYL MALATE•TRIETHYLHEXANOIN•HYDROGENATED
POLYISOBUTENE•TRIISOSTEARIN•PHYTOSTERYL/OCTYLDODECYL LAUROYL
GLUTAMATE•POLYETHYLENE•MICROCRYSTALLINE WAX•WATER•BUTYLENE
GLYCOL•GLYCERIN•POLYGLYCERYL-2 DIISOSTEARATE•TOCOPHERYL
ACETATE•PEG/PPG-36/41 DIMETHYL ETHER•ARGANIA SPINOSA KERNEL
OIL•STEARYL
GLYCYRRHETINATE•MORTIERELLA OIL•GINKGO BILOBA LEAF
EXTRACT•THYMUS
SERPYLLUM EXTRACT•PANAX GINSENG ROOT EXTRACT•SODIUM ACETYLATED
HYALURONATE•SODIUM HYALURONATE•SILICA DIMETHYL SILYLATE•LITHIUM
MAGNESIUM SODIUM
SILICATE•TOCOPHEROL•SIMETHICONE•B