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

Brightening and moisturizing facial SPF 30 by

Drug Labeling and Warnings

Brightening and moisturizing facial SPF 30 by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd. DBA Belcorp
USA, Miami, FL 33126

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

L'BEL
DERMO CLARITÉ

brightening and moisturizing facial
lotion SPF 30

30 ml e (1 fl.oz.)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-971
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-971-02	1 in 1 BOX	09/26/2016
1	NDC: 14783-971-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-971)