Drug Facts

Active Ingredients	Purpose
AVOBENZONE 3.00%	Sunscreen
ENSULIZOLE 3.00 %	Sunscreen
OCTISALATE 5.00 %	Sunscreen
OCTOCRYLENE 5.00 %	Sunscreen
OXYBENZONE 6.00 %	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 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, 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, CETYL ALCOHOL, GLYCERYL STEARATE, CHLORPHENESIN, FRAGRANCE, VIGNA ACONITIFOLIA SEED EXTRACT, DIMETHYLMETHOXY CHROMANYL PALMITATE, PEG-75 STEARATE, SODIUM COCOYL GLUTAMATE, TETRASODIUM EDTA, CETETH-20, STEARETH-20, BUTYLPARABEN, SORBIC ACID, METHYLPARABEN, ALPHA-ISOMETHYL IONONE, HYDROXYCITRONELLAL, d-LIMONENE, LINALOOL, BENZYL SALICYLATE, CITRONELLOL.

Dist. by Ventura Corp, Ltd.,
San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

L'BEL
DERMO CLARITÉ

brightening and moisturizing facial
lotion SPF 30

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

BRIGHTENING AND MOISTURIZING FACIAL SPF 30
avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-993
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)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
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)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHLORPHENESIN (UNII: I670DAL4SZ)
MOTH BEAN (UNII: H7938ON8E5)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
PEG-75 STEARATE (UNII: OT38R0N74H)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
EDETATE SODIUM (UNII: MP1J8420LU)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
SORBIC ACID (UNII: X045WJ989B)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-993-02	1 in 1 BOX	09/26/2016
1	NDC:13537-993-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/26/2016

Labeler - Ventura Corporation LTD (602751344)