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

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, 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.

P.R.: Distributed by Ventura Corporation, Ltd.
San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

L'BEL

clarifying and moisturizing
facial lotion with SPF 30

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Carton

LBEL DERMO CLARITE CLARIFYING AND MOISTURIZING WITH SPF 30
avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-404
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:13537-404-01	1 in 1 BOX
1	NDC:13537-404-02	30 mL in 1 BOTTLE
2	NDC:13537-404-03	1 in 1 BOX
2	NDC:13537-404-04	3 mL in 1 BOTTLE
3	NDC:13537-404-05	1 mL in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/13/2011

Labeler - Ventura Corporation Ltd. (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star, S. A.(Colombia)		880160197	MANUFACTURE(13537-404)

Name	Address	ID/FEI	Business Operations
Establishment
Yobel Supply Chain Management (Peru)		934116930	MANUFACTURE(13537-404)

L'BEL clarifying and moisturizing facial lotion with SPF 30