VIVIDLY BRILLIANT PERFECTING- hydroquinone liquid

Vividly Brilliant Perfecting by

Drug Labeling and Warnings

Vividly Brilliant Perfecting by is a Otc medication manufactured, distributed, or labeled by AMCOL Health & Beauty Solutions, Inc. DBA, AMCOL Household & Personal Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

HBS Code (Labeler): FP60402-50.2
Distributor: Derma Faith

Human Prescription Drug
Active Ingredient: Hydroquinone 4%

CARTON TEXT

________________________________________________________

vividly brilliant
perfecting lotion

derma faith

50 ml/1.7 fl oz

vividly brilliant
perfecting lotion

Directions:

Apply a single pump to face in the evening. If you have never used a retinol product before, begin by limiting use to twice a week, gradually increasing frequency to every other night, and then advancing to each evening or as tolerated. Mild redness, peeling and irritation is expected when using this product.

INDICATIONS & USAGE

Use daily sun protection during use of this product. Avoid getting in eyes. If contact occurs, rinse eyes thoroughly with water.

Caution:

Do not use if you are pregnant, lactating or planning to become pregnant.

Keep out of reach of children.

Derma Faith LLC
5701 W. Slaughter Lane
A130 #337
Austin, TX 78749
Made in the U.S.A.
www.dermafaith.com
M050839

This extra-strength formula features patented MICROSPONGE® Technology to gently, yet effectively help reduce the appearance of dark spots and fine lines.

Active Ingredients:

Hydroquinone 4.0%

PURPOSE

Inactive Ingredients:

Water, Caprylic/Capric, Triglyceride, Cetearyl Alcohol, Glycerin, Polysorbate 60, Dimethicone, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, C10-30 Cholesterol/Lanosterol Esters, Cetyl Ricinoleate, Cetyl Alcohol, Benzyl Alcohol, Polyacrylamide, Cetyl Phosphate, Sodium Metabisulfite, TEA-Stearate, Phenoxyethanol, Magnesium Aluminum Silicate, Cyclopentasiloxane, Triethanolamine, C13-14 Isoparaffin, PEG-10 Soy Sterol, Cyclohexasiloxane, Disodium EDTA, Methylparaben, Retinol, Polysorbate 20, Laureth-7, Bisabolol, Ascorbic Acid, Tocopheryl Acetate, BHT, Ascorbyl Palmitate, Propyl Gallate

________________________________________________________

150609

AMCOL Health & Beauty Solutions, Inc. DBA
301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com
lauren.haase@amcol.com

Principal Display Panel - Carton Label

vividly brilliant

perfecting lotion

derma
faith

50 ml/1.7 fl oz

Principal Display Panel - Bottle Label

vividly brilliant

perfecting lotion

derma
faith

50 ml/1.7 fl oz

INGREDIENTS AND APPEARANCE

VIVIDLY BRILLIANT PERFECTING 
hydroquinone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68634-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE)	hydroquinone	40 g  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
medium-chain triglycerides (UNII: C9H2L21V7U)
cetostearyl alcohol (UNII: 2DMT128M1S)
glycerin (UNII: PDC6A3C0OX)
polysorbate 60 (UNII: CAL22UVI4M)
dimethicone (UNII: 92RU3N3Y1O)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)
C10-30 cholesterol/lanosterol esters (UNII: 137SL7IL0Y)
cetyl ricinoleate (UNII: 1P677500YD)
cetyl alcohol (UNII: 936JST6JCN)
benzyl alcohol (UNII: LKG8494WBH)
cetyl phosphate (UNII: VT07D6X67O)
sodium metabisulfite (UNII: 4VON5FNS3C)
trolamine Stearate (UNII: 1J6JM3JE61)
phenoxyethanol (UNII: HIE492ZZ3T)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
cyclomethicone 5 (UNII: 0THT5PCI0R)
trolamine (UNII: 9O3K93S3TK)
C13-14 isoparaffin (UNII: E4F12ROE70)
PEG-10 soy sterol (UNII: FG54K98L0Q)
cyclomethicone 6 (UNII: XHK3U310BA)
edetate disodium (UNII: 7FLD91C86K)
methylparaben (UNII: A2I8C7HI9T)
retinol (UNII: G2SH0XKK91)
polysorbate 20 (UNII: 7T1F30V5YH)
Laureth-7 (UNII: Z95S6G8201)
levomenol (UNII: 24WE03BX2T)
ascorbic acid (UNII: PQ6CK8PD0R)
.alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
ascorbyl palmitate (UNII: QN83US2B0N)
propyl gallate (UNII: 8D4SNN7V92)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68634-051-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	01/01/2015

Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)

Establishment
Name	Address	ID/FEI	Business Operations
AMCOL Household & Personal Care		872684803	MANUFACTURE(68634-051) , PACK(68634-051) , LABEL(68634-051) , ANALYSIS(68634-051)