BRIGHTEN

Manufacturer: CEN BEAUTY LLC
Effective date: 2013-03-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:34:48

Label at a glance#

ProductBRIGHTEN LIGHTENING

Active ingredientHYDROQUINONE

Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

ZINC OXIDE 15%

OCTINOXATE 6%

OTC - PURPOSE SECTION

PURPOSE

SUNSCREEN

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

DO NOT USE

IF YOU HAVE VERY SENSITIVE SKIN

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT

Keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - ASK DOCTOR SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BB_Lightening Gel-HQ_1oz_Tubes_ARTWORK_FRBB_Lightening Gel-HQ CX621

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199176	hydroquinone 2 % Topical Gel	PSN	1
199176	hydroquinone 0.02 MG/MG Topical Gel	SCD	1
199176	hydroquinone 2 % Topical Gel	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
HYDROQUINONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54272-301-11	2019-11-27	C162847	48780-1	9855d018-de86-cd31-e053-dbdaa90ab51a	c4f30486-d2ae-403c-9113-3f2a5b1476d5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54272-301-11	BRIGHTENLIGHTENING	30 mL in 1 TUBE	GEL	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54272-301	BRIGHTEN LIGHTENING (HYDROQUINONE) GEL [CEN BEAUTY LLC]	1	Legacy NDC, 1 package rows	20130306_c4f30486-d2ae-403c-9113-3f2a5b1476d5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	1
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	1
1,10-DECANEDIOL	INACTIVE INGREDIENT	5I577UDK52	1
10-HYDROXYDECANOIC ACID	INACTIVE INGREDIENT	NP03XO416B	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	1
ANGELICA SINENSIS WHOLE	INACTIVE INGREDIENT	697D19QDBN	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
GLYCERETH-7 TRIMETHYL ETHER	INACTIVE INGREDIENT	XMC7402M60	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	1
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	1
OAT	INACTIVE INGREDIENT	Z6J799EAJK	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

BRIGHTEN LIGHTENING
HYDROQUINONE
WATER
ASCORBIC ACID
ALLANTOIN
AMINOMETHYLPROPANOL
GLYCERIN
OAT
ANGELICA SINENSIS WHOLE
BUTYLENE GLYCOL
10-HYDROXYDECANOIC ACID
1,10-DECANEDIOL
LECITHIN, SOYBEAN
EDETATE DISODIUM
LACTIC ACID
GLYCERETH-7 TRIMETHYL ETHER
ETHYLHEXYLGLYCERIN
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
HYALURONATE SODIUM
SODIUM METABISULFITE
POTASSIUM SORBATE
XANTHAN GUM
PHENOXYETHANOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54272-301	54272-301-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROQUINONE	XV74C1N1AE	ACTIB
WATER	059QF0KO0R	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
ALLANTOIN	344S277G0Z	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
GLYCERIN	PDC6A3C0OX	IACT
OAT	Z6J799EAJK	IACT
ANGELICA SINENSIS WHOLE	697D19QDBN	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
10-HYDROXYDECANOIC ACID	NP03XO416B	IACT
1,10-DECANEDIOL	5I577UDK52	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
LACTIC ACID	33X04XA5AT	IACT
GLYCERETH-7 TRIMETHYL ETHER	XMC7402M60	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	R33S7TK2EP	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
XANTHAN GUM	TTV12P4NEE	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 310 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / ORAL		640 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / RESPIRATORY (INHALATION)	0.04 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	LOTION / TOPICAL	0.2 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	AEROSOL, FOAM / TOPICAL		11 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET / ORAL	8 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRAMUSCULAR	1.16 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / INFILTRATION	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / ORAL		600 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRACARDIAC	0.01 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRALESIONAL	0.1 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / INTRAVENOUS		79 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SOLUTION / ORAL		192 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ALLANTOIN	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SUSPENSION / TOPICAL	0.7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	TABLET, FILM COATED / ORAL	0.33 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	CONCENTRATE / ORAL	6 mg/1ml		Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRAMUSCULAR	27.5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION/ DROPS / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2d9bf516-a130-4aaf-8efb-600250a7236d			c4f30486-d2ae-403c-9113-3f2a5b1476d5	2013-03-05	Warnings	Exact identifier spl id: 2d9bf516-a130-4aaf-8efb-600250a7236d spl set id: c4f30486-d2ae-403c-9113-3f2a5b1476d5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.