MEDICATED FADE CREME WITH SUNSCREEN- hydroquinone and octinoxate cream 
Bluefield Associates, Inc.

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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Medicated Fade Creme with Sunscreen

PRINCIPAL DISPLAY PANEL

FadeCreme

Active Ingredient

Hydroquinone U.S.P. 2%

Purpose

Skin Lightener

Active Ingredient

Octinoxate 2.5%

Purpose

Sunscreen

Uses:

Warnings

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

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

Keep out of the reach of children.

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?

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

Directions

Inactive Ingredients

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).

MEDICATED FADE CREME WITH SUNSCREEN 
hydroquinone and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16708-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.02 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16708-002-011 in 1 BOX
1113.5 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A10/26/2015
Labeler - Bluefield Associates, Inc. (626594667)
Establishment
NameAddressID/FEIBusiness Operations
Bluefield Associates, Inc.626594667manufacture(16708-002)

Revised: 10/2015
Document Id: 22c9b304-c3c3-04b4-e054-00144ff88e88
Set id: 22c9b304-c3c4-04b4-e054-00144ff88e88
Version: 1
Effective Time: 20151026
 
Bluefield Associates, Inc.