VIVIDLY BRILLIANT PERFECTING- hydroquinone liquid 
AMCOL Health & Beauty Solutions, Inc. DBA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vividly Brilliant Perfecting Lotion

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.

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%

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

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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 - Carton Label

Principal Display Panel - Bottle Label

vividly brilliant

perfecting lotion

derma
faith

50 ml/1.7 fl oz

Principal Display Panel - Bottle Label
VIVIDLY BRILLIANT PERFECTING 
hydroquinone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE) hydroquinone40 g  in 2 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68634-051-011 in 1 CARTON
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A01/01/2015
Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
Establishment
NameAddressID/FEIBusiness Operations
AMCOL Household & Personal Care872684803MANUFACTURE(68634-051) , PACK(68634-051) , LABEL(68634-051) , ANALYSIS(68634-051)

Revised: 6/2015
Document Id: e5da532f-240f-43de-8a67-30f86c44ede4
Set id: 081cc08d-d9e9-4140-8c67-9b5fd998a5ff
Version: 1
Effective Time: 20150603
 
AMCOL Health & Beauty Solutions, Inc. DBA