LBEL PROTEGE EXPERT- octinoxate, octisalate, octocrylene, oxybenzone, and titanium dioxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Octinoxate 7.5%, Octisalate 4%, Octocrylene 10%, Oxybenzone 6%, Titanium dioxide 1%

Available from:

Ventura International, Limited

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

sunscreen - Helps prevent sunburn. - Higher SPF gives more sunburn protection. - Provides high protection against sunburn - Retains SPF after 40 minutes of activity in the water.

Authorization status:

OTC monograph not final

Summary of Product characteristics

LBEL PROTEGE EXPERT- OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE,
AND TITANIUM
DIOXIDE CREAM
VENTURA INTERNATIONAL, LIMITED
_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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L'BEL
PROTÈGE
EXPERT
SUNSCREEN FOR EYES
CONTOUR AND LIPS
SPF 30
_DRUG FACTS_
ACTIVE INGREDIENTS
Octinoxate 7.5%, Octisalate 4%, Octocrylene 10%, Oxybenzone 6%,
Titanium dioxide 1%
PURPOS E
sunscreen
US ES
Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Provides high protection against sunburn
Retains SPF after 40 minutes of activity in the water.
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove.
STOP USE AND ASK A DOCTOR IF rash or irritation develops and lasts.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
Apply liberally before sun exposure and as needed
OTHER INFORMATION
Sun alert: Limiting sun exposure, waring protective clothing, and
using sunscreen may reduce the
risk of skin aging, skin cancer, and other harmful effects of the sun.
INACTIVE INGREDIENTS
Ozokerite, hydrogenated vegetable oil, petrolatum, butyrosperum parkii
(butyrospermum parkii (shea
butter)), ricinus communis seed oil (ricinus communis (castor ) seed
oil), c12-15 alkyl benzoate,
isopropyl lanolate, paraffin, copernicia cerifera cera (copernicia
cerifera (carnauba ) wax), isopropyl
myristate, bht, propylparaben, tocopheryl acetate, octyldodecanol,
cera microcristallina
(microcrystalline wax), bha, phospholipids, cholesterol, cera alba
(beeswax), cetearyl alcohol, cetearyl
glucoside, euphorbia cerifera (candelilla) wax, polyglyceryl-2
dipolyhydroxystearate,
glycosphingolipids
US: Dist. by Ventura International Ltd, San Francisco, CA 94111.
P.R.: Dist. by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 5 G BOTTLE CARTON
L'BEL
PR