BRIGHTEN LIGHTENING- hydroquinone gel

BRIGHTEN by

Drug Labeling and Warnings

BRIGHTEN by is a Otc medication manufactured, distributed, or labeled by CEN BEAUTY LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

ZINC OXIDE 15%

OCTINOXATE 6%

PURPOSE

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

USES

• Lightens discolored skin such as freckles, age and liver spots or pigment in the skin that may occur from pregnancy or from the use of oral contraceptives

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

DO NOT USE

• IF YOU HAVE VERY SENSITIVE SKIN

WHEN USING

WHEN USING THIS PRODUCT

• Keep out of eyes. Rinse with water to remove.

STOP USE

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

ASK DOCTOR

ASK A DOCTOR BEFORE USE

• On children under 12 years of age
• If you are pregnant, breastfeeding or intend to become pregnant within 3 months of use.

DOSAGE & ADMINISTRATION

DIRECTIONS

• Apply a thin layer on affected area twice daily or as directed by a doctor.
• If no improvement is seen after 3 months treatment, discontinue use.
• Lightening effect may not be noticeable when used on very dark skin.
• Limit sun exposure during and after use to prevent darkening from reoccurring.
• Use a sun blocking agent or protective clothing. This product is not for use in the prevention of sunburn.
• Consult your physician before use.

OTHER SAFETY INFORMATION

Other Information

• STORE AT 15-30°C (59-86°F)
• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENT

INGREDIENTS

aqua (water), cyclopentasiloxane, PEG-10 dimethicone, dimethicone, butylene glycol, cyclohexasiloxane, glycerin, carollina officinalis extract, algae extract, avena sativa (oat) kernel extract, angelica sinensis extract, 10-hydroxydecanoic acid, sebacic acid, 1,10-decanediol acid, betaine, dimethicone/vinyl dimethicone crosspolymer, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, lecithin, dimethicone/PEG-10/15 crosspolymer, triethoxycaprylylsilane, decamethylcyclopentasiloxane, trifluoromethyl C1-C4 alkyl dimethicone, quaternium-90, bentonite, butylene glycol, sodium chloride, sodium citrate, ethylhexylglycerin, propylene carbonate, propylene glycol, potassium sorbate, methylisothiazolinone, iodopropynyl butylcarbamate, phenoxyethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRIGHTEN  LIGHTENING
hydroquinone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54272-301
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALLANTOIN (UNII: 344S277G0Z)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
OAT (UNII: Z6J799EAJK)
ANGELICA SINENSIS WHOLE (UNII: 697D19QDBN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)
1,10-DECANEDIOL (UNII: 5I577UDK52)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LACTIC ACID (UNII: 33X04XA5AT)
GLYCERETH-7 TRIMETHYL ETHER (UNII: XMC7402M60)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54272-301-11	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	02/21/2013

Labeler - CEN BEAUTY LLC (078664118)

Registrant - CEN BEAUTY LLC (078664118)