Medicated Fade Creme with Sunscreen

Manufacturer: Bluefield Associates, Inc.
Effective date: 2015-10-26
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:43:55

Label at a glance#

ProductMedicated Fade Creme with Sunscreen

Active ingredientHYDROQUINONE, OCTINOXATE

Label structure12 sections

Indications and uses

Lightens dark discolorations on the skin such as age spots, dark patches or freckles that may occur from medication, pregnancy or exposure to the elements. Contains a sunscreen to help prevent darkening from reoccurring.

Dosage and administration

Spread a thin layer into patches on face, hands, arms or body.. Use twice daily or as directed by a doctor and in 4-6 weeks the effect should be evident. Not for use on children under 12 except on doctor's intructions.

Contacts and useful links#

PhoneLabel contact1-800-423-0306

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FadeCreme

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone U.S.P. 2%

Purpose

OTC - PURPOSE SECTION

Skin Lightener

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 2.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Lightens dark discolorations on the skin such as age spots, dark patches or freckles that may occur from medication, pregnancy or exposure to the elements.
Contains a sunscreen to help prevent darkening from reoccurring.

Warnings

WARNINGS SECTION

For External use only. Avoid contact with eyes. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor.

Do Not use on

OTC - DO NOT USE SECTION

children under 12 years of age unless directed by a doctor.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a doctor before use.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-423-0306 or sales@bluefieldInc.com

Directions

DOSAGE & ADMINISTRATION SECTION

Spread a thin layer into patches on face, hands, arms or body..
Use twice daily or as directed by a doctor and in 4-6 weeks the effect should be evident.
Not for use on children under 12 except on doctor's intructions.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), White Petrolatum, Cetyl Alcohol, Isopropyl Palmitate, Stearic Acid, Propylene Glycol, Stearic Acid, Ammonium Lauryl Sulfate, Dimethicone, Diazolidinyl Urea, Methylparaben, Propylparaben, Glyceryl Stearate,Sodium Metabisulfite, Ascorbic Acid, BHA, Propul Gallate,Trisodium EDTA, Fragrance (Parfum).

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16708-002-01	2020-01-31	C162847	48780-1	9d75b9d0-4ee5-f424-e053-dadaa90a57ce	Medicated Fade Creme with Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16708-002-01	Medicated Fade Creme with Sunscreen	1 in 1 BOX	CREAM	1		1
16708-002-01	Medicated Fade Creme with Sunscreen	113.5 g in 1 JAR	CREAM	113.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16708-002	MEDICATED FADE CREME WITH SUNSCREEN (HYDROQUINONE AND OCTINOXATE) CREAM [BLUEFIELD ASSOCIATES, INC.]	1	Legacy NDC, 2 package rows	20151027_22c9b304-c3c4-04b4-e054-00144ff88e88.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROQUINONE	ACTIVE INGREDIENT	XV74C1N1AE	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
HYDROQUINONE	ACTIVE MOIETY	XV74C1N1AE	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
AMMONIUM LAURYL SULFATE	INACTIVE INGREDIENT	Q7AO2R1M0B	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
EDETATE TRISODIUM	INACTIVE INGREDIENT	420IP921MB	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Medicated Fade Creme with Sunscreen
Hydroquinone and Octinoxate
ASCORBIC ACID
PROPYL GALLATE
WATER
EDETATE TRISODIUM
GLYCERYL MONOSTEARATE
CETYL ALCOHOL
ISOPROPYL PALMITATE
STEARIC ACID
AMMONIUM LAURYL SULFATE
DIMETHICONE
EDETATE DISODIUM
SODIUM METABISULFITE
BUTYLATED HYDROXYTOLUENE
METHYLPARABEN
PROPYLPARABEN
DIAZOLIDINYL UREA
HYDROQUINONE
OCTINOXATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16708-002	16708-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASCORBIC ACID	PQ6CK8PD0R	IACT
PROPYL GALLATE	8D4SNN7V92	IACT
WATER	059QF0KO0R	IACT
EDETATE TRISODIUM	420IP921MB	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
CETYL ALCOHOL	936JST6JCN	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
STEARIC ACID	4ELV7Z65AP	IACT
AMMONIUM LAURYL SULFATE	Q7AO2R1M0B	IACT
DIMETHICONE	92RU3N3Y1O	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
HYDROQUINONE	XV74C1N1AE	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB

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 7 · 415 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, EMULSION / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 43 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / ORAL		600 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SUSPENSION, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / RESPIRATORY (INHALATION)	0.3 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / SUBCUTANEOUS		79 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, SOLUTION / INTRAVENOUS		4 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRALESIONAL	0.1 %w/v		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
22c9b304-c3c3-04b4-e054-00144ff88e88			22c9b304-c3c4-04b4-e054-00144ff88e88	2015-10-26	Warnings	Exact identifier spl id: 22c9b304-c3c3-04b4-e054-00144ff88e88 spl set id: 22c9b304-c3c4-04b4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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