LUMIPEARL DARK MARK CORRECTOR- hydroquinone cream

Lumipearl Dark Mark Corrector by

Drug Labeling and Warnings

Lumipearl Dark Mark Corrector by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Fact Label

Active ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use

Works deep in the skin's surface to fade spots

Warnings

For external use only

When using this product

• avoid unnecessary sun exposure and use a sunscreen.
• some users of this product may experience a mild skin irritation.
• do not use on children under 12 years of age, unless directed by a doctor.

Stop use and ask a doctor

• skin irritation becomes severe or gradual darkening of the skin occurs.
• if pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

• if swallowed, get medical help or contact a Poison Control Center right away.
• Discontinue use if no improvement is seen after 3 months of treatment.
• Avoid unnecessary sun exposure and use a sunscreen during the day of SPF 15 or higher.

Directions

After cleansing the skin, apply a thin layer of product to age spots and dark spots.

Inactive ingredients

water, octyldodecanol, cyclopentasiloxane, hexylene glycol, polyquaternium-37, glycolic acid, cyclohexasiloxane, cetearyl alcohol, propylene glycol dicaprylate/dicaprate, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, propylene glycol, glyceryl dilaurate, PPG-1 trideceth-6, glyceryl stearate, PEG-100 stearate, PEG-40 stearate, sodium sulfite, sodium metabisulfite, sodium hydroxide, disodium EDTA, diazolidinyl urea, methylparaben, propylparaben, fragrance.

Questions or comments?

Within US 1-888-920-7477

SPL UNCLASSIFIED SECTION

Dist. by Guthy-Renker® LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Label

LuMIPEARL™

DARK MARK
CORRECTOR

1 FL. OZ. / 30mL

INGREDIENTS AND APPEARANCE

LUMIPEARL DARK MARK CORRECTOR 
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE)	Hydroquinone	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Octyldodecanol (UNII: 461N1O614Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
Hexylene Glycol (UNII: KEH0A3F75J)
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)
Glycolic Acid (UNII: 0WT12SX38S)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
PEG-40 Stearate (UNII: ECU18C66Q7)
Glyceryl Dilaurate (UNII: MFL3ZIE8SK)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Hydroxide (UNII: 55X04QC32I)
PPG-1 Trideceth-6 (UNII: 1K7417JX6Q)
Sodium Sulfite (UNII: VTK01UQK3G)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Sodium Metabisulfite (UNII: 4VON5FNS3C)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Methylparaben (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
Propylparaben (UNII: Z8IX2SC1OH)
HEXAMETHYLCYCLOTRISILOXANE (UNII: EPV75L8O0R)
Ascorbyl Palmitate (UNII: QN83US2B0N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-055-11	30 mL in 1 TUBE; Type 0: Not a Combination Product	12/30/2017
2	NDC: 70605-055-02	10 mL in 1 TUBE; Type 0: Not a Combination Product	12/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part358A	12/30/2017

Labeler - Guthy-Renker LLC (948861877)