Cyberwhite Ex Extra Intensive Bb Creme Multi Action Formula Spf35 (Octinoxate, Octisalate, Zinc Oxide, Oxybenzone, Titanium Dioxide) Cream [Estee Lauder Inc] -

CYBERWHITE EX EXTRA INTENSIVE BB CREME MULTI ACTION FORMULA SPF35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]
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NDC	11559-004-01, 11559-004-02
Set ID	05e6d02e-0b0a-4b4c-9ff4-967936d1848b
Category	HUMAN OTC DRUG LABEL
Packager	ESTEE LAUDER INC
Generic Name
Product Class
Product Number
Application Number	PART352

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ACTIVE INGREDIENT

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 4.00% [] ZINC OXIDE 3.50% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%
WARNINGS

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.
PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
ESTEE LAUDER
CYBER WHITE EX

EXTRA INTENSIVE BB CREME

MULTI-ACTION
FORMULA
SPF 35

1.7 FL OZ. LIQ./50 ML

ESTEE LAUDER DIST.
NEW YORK, NY 10022

ESTEELAUDER.COM
WJRJ

INGREDIENTS AND APPEARANCE

CYBERWHITE EX EXTRA INTENSIVE BB CREME MULTI ACTION FORMULA SPF35
octinoxate, octisalate, zinc oxide, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11559-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 mL in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.5 mL in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 mL in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.1 mL in 100 mL

#	Item Code	Package Description
Packaging
1	NDC:11559-004-01	1 in 1 CARTON
1	NDC:11559-004-02	50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2010

Labeler - ESTEE LAUDER INC (005914387)

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER COSMETICS, LTD		205952385	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
ESTEE LAUDER N.V.		370151326	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Aramis Inc.		042918826	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Northtec Bristol		949264774	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Northtec Keystone		618107429	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
PADC 1		110482184	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics, Ltd.		255175580	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics, Ltd		253616536	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Cosmetics Distribution Center		208579636	manufacture, label, relabel

Name	Address	ID/FEI	Business Operations
Establishment
Estee Lauder Kabushiki Kaisha		712808195	relabel, repack

Name	Address	ID/FEI	Business Operations
Establishment
Whitman Laboratories Ltd.		216866277	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Aveda Corporation		071352058	manufacture

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Medic

CYBERWHITE EX EXTRA INTENSIVE BB CREME MULTI ACTION FORMULA SPF35 (OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ESTEE LAUDER INC]

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