LBEL- octinoxate, octisalate, and oxybenzone cream

LBel by

Drug Labeling and Warnings

LBel by is a Otc medication manufactured, distributed, or labeled by VENTURA INTERNATIONAL LTD., . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate (7.5 %), Octisalate (5 %), Oxybenzone (6 %)

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• provides moderate protection against sunburn

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 and 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 smoothly twice a day before sun exposure and as needed.
• Reapply as needed or after towel drying, swimming or sweating.
• Moderate sun protection product.
• Children under 6 months of age: ask a doctor.

Other information

• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Inactive ingredients

Aqua (water), cyclohexasiloxane, c12-15 alkyl benzoate, cetearyl alcohol, ethylhexyl stearate, cyclopentasiloxane, citrus unshui peel extract, propylene glycol, triethanolamine, glycerin, dicetyl phosphate, ceteth-10 phosphate, sodium lactate, tocopheryl acetate, phenoxyethanol, diazolidinyl urea, parfum (fragance), glycolic acid, methylparaben, sucrose, urea, sodium citrate, propylparaben, malic acid, tartaric acid, camellia sinensis leaf extract.

SPL UNCLASSIFIED SECTION

US: Distributed by Ventura International, Ltd. San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

L'BEL

CLARIFIQUE
DERMO RADIANCE
MAINS SPF 15

clarifying and illuminating
treatment hand cream spf 15

100 g e (3.5 oz.)

INGREDIENTS AND APPEARANCE

LBEL   CLARIFIQUE DERMO RADIANCE MAINS SPF 15
octinoxate, octisalate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-077
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 6 (UNII: XHK3U310BA)
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)
cetostearyl alcohol (UNII: 2DMT128M1S)
cyclomethicone 5 (UNII: 0THT5PCI0R)
tangerine (UNII: KH3E3096OO)
propylene glycol (UNII: 6DC9Q167V3)
trolamine (UNII: 9O3K93S3TK)
glycerin (UNII: PDC6A3C0OX)
dihexadecyl phosphate (UNII: 2V6E5WN99N)
phosphate ion (UNII: NK08V8K8HR)
sodium lactate (UNII: TU7HW0W0QT)
phenoxyethanol (UNII: HIE492ZZ3T)
diazolidinyl urea (UNII: H5RIZ3MPW4)
glycolic acid (UNII: 0WT12SX38S)
methylparaben (UNII: A2I8C7HI9T)
sucrose (UNII: C151H8M554)
urea (UNII: 8W8T17847W)
sodium citrate (UNII: 1Q73Q2JULR)
propylparaben (UNII: Z8IX2SC1OH)
malic acid (UNII: 817L1N4CKP)
tartaric acid (UNII: W4888I119H)
green tea leaf (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-077-61	1 in 1 BOX
1	NDC: 14783-077-62	100 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/15/2010

Labeler - VENTURA INTERNATIONAL LTD., (603192787)