Esoterica Daytime with Moisturizers and Sunscreen

Dosage form: cream
Ingredients: hydroquinone 20mg in 1g, oxybenzone 25mg in 1g, padimate o 33mg in 1g
Labeler: Medicis Pharmaceutical Corp
NDC Code: 99207-291

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 contraceptives. 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, isopropyl myristate NF, stearyl alcohol NF, glyceryl stearate and sodium lauryl sulfate NF, propylene glycol USP, ozokerite, poloxamer 188, steareth-20, ceteareth-3, fragrance, dimethicone, sodium metabisulfite NF, methylparaben NF, propylparaben NF, sodium lauryl sulfate NF, butylated hydroxyanisole NF, anhydrous citric acid USP, edetate disodium

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 - 70 g Jar Carton

Skin Lightener with Moisturizers and Sunscreen
NDC # 99207-291-02

E
ESOTÉRICA®

ESOTÉRICA®
FADE CREAM

DAYTIME
With Moisturizers
and Sunscreen

Net Wt.
2.5 oz (70 g)

ESOTERICA   DAYTIME WITH MOISTURIZERS AND SUNSCREEN
hydroquinone, oxybenzone, and padimate o cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:99207-291
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydroquinone (hydroquinone) hydroquinone20 mg  in 1 g
oxybenzone (oxybenzone) oxybenzone25 mg  in 1 g
padimate o (padimate o) padimate o33 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
isopropyl myristate 
stearyl alcohol 
glyceryl monostearate 
sodium lauryl sulfate 
propylene glycol 
ceresin 
poloxamer 188 
steareth-20 
dimethicone 
sodium metabisulfite 
methylparaben 
propylparaben 
butylated hydroxyanisole 
anhydrous citric acid 
edetate disodium 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:99207-291-021 JAR (JAR) in 1 CARTON
170 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A06/01/2005
Labeler - Medicis Pharmaceutical Corp (182837492)
Establishment
NameAddressID/FEIOperations
Contract Pharmaceutical Limited248761249MANUFACTURE

Revised: 09/2011
 
Medicis Pharmaceutical Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)