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LBEL

Ventura International Ltd.

L'BEL DERMO CLARITÉ


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

Butyl methoxydibenzoylmethane 3.0%,

Ensulizole 3.0%,

Octisalate 5.0%,

Octocrylene 5.0%,

Oxybenzone 6.0%

Purpose

Sunscreen

LBEL Uses

  • 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 damage 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.
  • Children under 6 months of age: Ask a doctor
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.

LBEL Other information

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

aqua (water), dicaprylyl carbonate, cetearyl alcohol, phenethyl benzoate, triethanolamine, cyclopentasiloxane, propylene glycol, methyl methacrylate crosspolymer, sorbitan stearate, triethylhexanoin, potassium cetyl phosphate, phenoxyethanol, dimethicone, stearyl dimethicone, ceteareth-20, xanthan gum, chlorphenesin, parfum (fragrance), vigna aconitifolia seed extract, cetyl alcohol, dimethylmethoxy chromanyl palmitate, glyceryl stearate, methylparaben, sodium cocoyl glutamate, tetrasodium edta, peg-75 stearate, butylparaben, sorbic acid, ceteth-20, steareth-20.

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

L'BEL
DERMO CLARITÉ

clarifying and moisturizing
facial lotion with SPF 30

30 ml e (1 fl.oz.)

LBEL

LBEL

Avobenzone, Ensulizole, Octisalate, Octocrylene, and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:14783-434
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 0.03 g
Ensulizole Ensulizole 0.03 g
OCTISALATE OCTISALATE 0.05 g
OCTOCRYLENE Octocrylene 0.05 g
OXYBENZONE OXYBENZONE 0.06 g

Inactive Ingredients

Ingredient Name Strength
water
DICAPRYLYL CARBONATE
ALCOHOL
phenethyl benzoate
TROLAMINE
CYCLOMETHICONE 5
propylene glycol
SORBITAN MONOSTEARATE
TRIETHYLHEXANOIN
potassium cetyl phosphate
PHENOXYETHANOL
DIMETHICONE
POLYOXYL 20 CETOSTEARYL ETHER
XANTHAN GUM
CHLORPHENESIN
moth bean
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
METHYLPARABEN
EDETATE SODIUM
peg-75 stearate
BUTYLPARABEN
sorbic acid
CETETH-20
Steareth-20

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:14783-434-02 30 in 1 BOTTLE
2 3 in 1 BOTTLE
3 NDC:14783-434-05 1 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-11-26


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