ESOTERICA DAYTIME WITH MOISTURIZERS AND SUNSCREEN- hydroquinone, oxybenzone, and padimate o cream

Esoterica by

Drug Labeling and Warnings

Esoterica by is a Otc medication manufactured, distributed, or labeled by Medicis Pharmaceutical Corp, Contract Pharmaceutical Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

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)

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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)

INGREDIENTS AND APPEARANCE

ESOTERICA  DAYTIME WITH MOISTURIZERS AND SUNSCREEN
hydroquinone, oxybenzone, and padimate o cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 99207-291
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE)	hydroquinone	20 mg  in 1 g
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y)	oxybenzone	25 mg  in 1 g
padimate o (UNII: Z11006CMUZ) (padimate o - UNII:Z11006CMUZ)	padimate o	33 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 99207-291-02	1 in 1 CARTON	06/01/2015	05/31/2020
1		70 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	06/01/2005	05/31/2020

Labeler - Medicis Pharmaceutical Corp (182837492)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmaceutical Limited		248761249	MANUFACTURE(99207-291)