ESOTÉRICA® FADE CREAM

Drug Labeling and Warnings

Drug Details [pdf]

ESOTERICA DAYTIME WITH SUNSCREEN- hydroquinone, oxybenzone, and padimate o cream 
Medicis Pharmaceutical Corp

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.

----------

ESOTÉRICA®
FADE CREAM

Drug Facts

Active ingredients:Purpose:

Hydroquinone USP 2%

Skin Lightener

Oxybenzone USP 2.5%

Sunscreen

Padimate O USP 3.3%

Sunscreen

Use

Lightens dark (brownish) areas on the skin such as freckles, age and liver spots, pigment in skin that may occur in pregnancy or from the use of oral contraceptions. Contains a sunscreen to help prevent darkening from reoccurring.

Warnings

For external use only.

Do not use

  • On inflamed or broken skin
  • For prevention of sunburn
  • As sunscreen
  • On children under 12 years of age unless directed by a physician

Ask a doctor or pharmacist before use if you are taking products containing resorcinol, phenol, or salicylic acid

When using this product

  • Avoid contact with eyes
  • Mild skin irritation may occur. If skin irritation becomes severe, stop use and consult a doctor
  • Limit sun exposure

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

Directions

Adults

  • Apply a small amount as a thin layer to affected areas twice daily or as directed by a doctor
  • For sensitive skin, test overnight on small area (inside elbow)
  • If no improvement is seen after 3 months of treatment, discontinue use. On very dark skin, lightening effect may not be noticeable
  • Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Other information

  • Store at room temperature
  • Tamper-evident carton
  • Serious side effects may be reported to the phone number provided in the Questions? section below.

Inactive ingredients

purified water USP, glyceryl monostearate, isopropyl palmitate NF, ozokerite wax, mineral oil light NF, stearyl alcohol NF, PEG 1500 monostearate, poloxamer 188, propylene glycol USP, steareth-20, laureth-23, allantoin ascorbate, sodium bisulfite NF, steareth-10, dimethicone, sodium lauryl sulfate NF, methylparaben NF, fragrance, propylparaben NF, edetate disodium, butylated hydroxyanisole

Questions?

1-800-900-6389 (24 hours a day, 7 days a week)

Distributed by:
MEDICIS
The Dermatology Company®

Scottsdale, AZ 85256

PRINCIPAL DISPLAY PANEL - 70g Carton

Skin Lightener with Sunscreen
NDC # 99207-292-02

E
ESOTÉRICA®

ESOTÉRICA®
FADE CREAM

DAYTIME
With Sunscreen

Net Wt.
2.5 oz (70g)

Principal Display Panel - 70g Carton
ESOTERICA  DAYTIME WITH SUNSCREEN
hydroquinone, oxybenzone, and padimate o cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 99207-292
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE) hydroquinone20 mg  in 1 g
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone25 mg  in 1 g
padimate o (UNII: Z11006CMUZ) (padimate o - UNII:Z11006CMUZ) padimate o33 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
glyceryl monostearate (UNII: 230OU9XXE4)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
ceresin (UNII: Q1LS2UJO3A)  
mineral oil (UNII: T5L8T28FGP)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
polyethylene glycol 1500 (UNII: 1212Z7S33A)  
poloxamer 188 (UNII: LQA7B6G8JG)  
propylene glycol (UNII: 6DC9Q167V3)  
steareth-20 (UNII: L0Q8IK9E08)  
laureth-23 (UNII: N72LMW566G)  
allantoin (UNII: 344S277G0Z)  
sodium bisulfite (UNII: TZX5469Z6I)  
steareth-10 (UNII: FD0913P475)  
dimethicone (UNII: 92RU3N3Y1O)  
sodium lauryl sulfate (UNII: 368GB5141J)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
edetate disodium (UNII: 7FLD91C86K)  
butylated hydroxyanisole (UNII: REK4960K2U)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 99207-292-021 in 1 CARTON06/01/200511/30/2016
170 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 finalpart358A06/01/200511/30/2016
Labeler - Medicis Pharmaceutical Corp (182837492)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmaceutical Limited248761249MANUFACTURE(99207-292)

Revised: 9/2011