LBEL DERMO CLARITE- avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion

LBEL by

Drug Labeling and Warnings

LBEL by is a Otc medication manufactured, distributed, or labeled by Ventura International Ltd., Bel Star, S. A.(Colombia), Yobel Supply Chain Management (Peru). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Butyl methoxydibenzoylmethane 3.0%,

Ensulizole 3.0%,

Octisalate 5.0%,

Octocrylene 5.0%,

Oxybenzone 6.0%

Purpose

Sunscreen

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.

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.

SPL UNCLASSIFIED SECTION

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.)

INGREDIENTS AND APPEARANCE

LBEL   DERMO CLARITE
avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-434
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g  in 1 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.03 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.05 g  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.06 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dicaprylyl carbonate (UNII: 609A3V1SUA)
alcohol (UNII: 3K9958V90M)
phenethyl benzoate (UNII: 0C143929GK)
trolamine (UNII: 9O3K93S3TK)
cyclomethicone 5 (UNII: 0THT5PCI0R)
propylene glycol (UNII: 6DC9Q167V3)
sorbitan monostearate (UNII: NVZ4I0H58X)
triethylhexanoin (UNII: 7K3W1BIU6K)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
phenoxyethanol (UNII: HIE492ZZ3T)
dimethicone (UNII: 92RU3N3Y1O)
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)
xanthan gum (UNII: TTV12P4NEE)
chlorphenesin (UNII: I670DAL4SZ)
moth bean (UNII: H7938ON8E5)
cetyl alcohol (UNII: 936JST6JCN)
glyceryl monostearate (UNII: 230OU9XXE4)
methylparaben (UNII: A2I8C7HI9T)
edetate sodium (UNII: MP1J8420LU)
peg-75 stearate (UNII: OT38R0N74H)
butylparaben (UNII: 3QPI1U3FV8)
sorbic acid (UNII: X045WJ989B)
ceteth-20 (UNII: I835H2IHHX)
steareth-20 (UNII: L0Q8IK9E08)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-434-01	1 in 1 BOX
1	NDC: 14783-434-02	30 mL in 1 BOTTLE
2	NDC: 14783-434-04	1 in 1 BOX
2		3 mL in 1 BOTTLE
3	NDC: 14783-434-05	1 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/26/2011

Labeler - Ventura International Ltd. (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star, S. A.(Colombia)		880160197	MANUFACTURE(14783-434)

Establishment
Name	Address	ID/FEI	Business Operations
Yobel Supply Chain Management (Peru)		934116930	MANUFACTURE(14783-434)