LBEL DERMO CLARITE BRIGHTENING AND MOISTURIZING FACIAL SPF 30- avobenzone, octisalate, and octocrylene lotion

LBEL DERMO CLARITE BRIGHTENING AND MOISTURIZING FACIAL SPF 30 by

Drug Labeling and Warnings

LBEL DERMO CLARITE BRIGHTENING AND MOISTURIZING FACIAL SPF 30 by is a Otc medication manufactured, distributed, or labeled by 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 1.80 %	Sunscreen
Octisalate 4.50 %	Sunscreen
Octocrylene 4.50 %	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, GLYCERIN, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, CYCLOHEXASILOXANE, ETHYLHEXYL METHOXYCRYLENE, POTASSIUM CETYL PHOSPHATE, TRIETHYLHEXANOIN, HYDROGENATED PALM GLYCERIDES, GLYCERYL STEARATE, PEG-100 STEARATE, SYNTHETIC FLUORPHLOGOPITE, HYDROXYACETOPHENONE, TITANIUM DIOXIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, VIGNA ACONITIFOLIA SEED EXTRACT, XANTHAN GUM, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, DIMETHYLMETHOXY CHROMANYL PALMITATE, CETEARYL ISONONANOATE, SODIUM COCOYL GLUTAMATE, ACACIA SENEGAL GUM, TETRASODIUM EDTA, CETEARETH-20, CETEARYL ALCOHOL, SODIUM HYDROXIDE, HYDROLYZED ALGIN, CETEARETH-12, CETYL PALMITATE, PHENOXYETHANOL, TIN OXIDE

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton

L'BEL

DERMO
CLARITÉ

brightening and
moisturizing facial
lotion SPF 30

30 ml e (1 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL DERMO CLARITE BRIGHTENING AND MOISTURIZING FACIAL SPF 30 
avobenzone, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.018 g  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.045 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.045 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
ACACIA (UNII: 5C5403N26O)
EDETATE SODIUM (UNII: MP1J8420LU)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-088-02	1 in 1 BOX	08/08/2018
1	NDC: 14141-088-01	30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/08/2018

Labeler - Bel Star S.A. (Colombia) (880160197)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14141-088)