LBEL DEFENSE 365 OIL-FREE DAILY PROTECTIVE FACIAL SPF 50- homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S), 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:

Ventura International LTD

INN (International Name):

Homosalate

Composition:

Homosalate 0.05 g in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Helps prevent sunburn.

Authorization status:

OTC monograph final

Summary of Product characteristics

LBEL DEFENSE 365 OIL-FREE DAILY PROTECTIVE FACIAL SPF 50- HOMOSALATE,
OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE
LOTION
VENTURA INTERNATIONAL LTD
_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 DÉFENSE 365 OIL-FREE DAILY PROTECTIVE FACIAL LOTION SPF 50
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
HOMOSALATE 5.00 %
Sunscreen
OCTINOXATE 7.00 %
Sunscreen
OCTISALATE 5.00 %
Sunscreen
OXYBENZONE 4.00 %
Sunscreen
TITANIUM DIOXIDE 6.24 %
Sunscreen
ZINC OXIDE 3.92%
Sunscreen
US ES
Helps prevent sunburn.
WARNINGS
SKIN CANCER / SKIN AGING ALERT: Spending time in the sun increases
your risk of skin cancer and
early skin aging. This product has been shown only to help prevent
sunburn, NOT skin cancer or early
skin aging.
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 swallowed, get medical help or
contact a Poison Control Center
right away.
DIRECTIONS
Apply liberally and evenly 15 minutes before sun exposure.
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor
OTHER INFORMATION
Protect the product in this container from excessive heat and direct
sun.
INACTIVE INGREDIENTS
WATER, DICAPRYLYL CARBONATE, PROPYLHEPTYL CAPRYLATE, GLYCERYL
STEARATE, POTASSIUM CETYL PHOSPHATE, ALCOHOL DENAT.,
CYCLOHEXASILOXANE,
POLYMETHYLSILSESQUIOXANE, GLYCERIN, SORBITAN STEARATE, BIS-ETHYLHEXYL
HYDROXYDIMETHOXY BENZYLMALONATE, DIMETHICONE, TOCOPHERYL ACETATE,
SILICA, METHICONE, PEG-8, CETEARETH-12, CETEARETH-20, PROPYLENE
GLYCOL,
PHENOXYETHANOL, METHYLPARABEN, AMBROSIA PERUVIANA LEAF EXTRACT,
CETEARYL ALCOHOL, CETYL PALMITATE, XANTHAN GUM, CAPRYLYL GLYCOL,
PROPYLPARABEN, CHLORPHENESIN, BUTYLENE GLYCOL, HELIANTHUS