ESOTERICA DAYTIME WITH MOISTURIZERS AND 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.

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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)

carton.jpg
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 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)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
glyceryl monostearate (UNII: 230OU9XXE4)  
sodium lauryl sulfate (UNII: 368GB5141J)  
propylene glycol (UNII: 6DC9Q167V3)  
ceresin (UNII: Q1LS2UJO3A)  
poloxamer 188 (UNII: LQA7B6G8JG)  
steareth-20 (UNII: L0Q8IK9E08)  
dimethicone (UNII: 92RU3N3Y1O)  
sodium metabisulfite (UNII: 4VON5FNS3C)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
butylated hydroxyanisole (UNII: REK4960K2U)  
anhydrous citric acid (UNII: XF417D3PSL)  
edetate disodium (UNII: 7FLD91C86K)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:99207-291-021 in 1 CARTON06/01/201505/31/2020
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 finalpart358A06/01/200505/31/2020
Labeler - Medicis Pharmaceutical Corp (182837492)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmaceutical Limited248761249MANUFACTURE(99207-291)

Revised: 9/2011
 
Medicis Pharmaceutical Corp