CYBER WHITE BRILLIANT CELLS FULL SPECTRUM BRIGHTENING UV PROTECTOR SPF 50- homosalate, octisalate, avobenzone, oxybenzone lotion

CYBER WHITE by

Drug Labeling and Warnings

CYBER WHITE by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER N.V., Len-Ron Manufacturing Division of Aramis Inc., Aramis Inc., Northtec Bristol, Northtec Keystone, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics, Ltd, Estee Lauder Cosmetics Distribution Center, Estee Lauder Kabushiki Kaisha, Whitman Laboratories Ltd., Aveda Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: HOMOSALATE 5.00% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] OXYBENZONE 3.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] METHYL TRIMETHICONE [] BUTYLOCTYL SALICYLATE [] NEOPENTYL GLYCOL DIHEPTANOATE [] POLYESTER-8 [] ALEURITES MOLUCCANA (KUKUI) SEED OIL [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] PEG-100 STEARATE [] BUTYLENE GLYCOL [] GLYCERYL STEARATE [] DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] LAMINARIA OCHROLEUCA EXTRACT [] ACETYL GLUCOSAMINE [] CAFFEINE [] C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER [] SODIUM HYALURONATE [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] SORBITOL [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] CAPRYLYL GLYCOL [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] CETYL ALCOHOL [] POTASSIUM CETYL PHOSPHATE [] ETHYLHEXYLGLYCERIN [] VP/EICOSENE COPOLYMER [] STEARIC ACID [] FRAGRANCE (PARFUM) [] DEHYDROXANTHAN GUM [] DISODIUM EDTA [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL [] MICA

WARNINGS

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

CYBER WHITE

BRILLIANT CELLS

FULL SPECTRUM
BRIGHTENING UV PROTECTOR

1 FL OZ LIQ/30 ML


ESTEE LAUDER DISTR.
NEW YORK, NY 10022

INGREDIENTS AND APPEARANCE

CYBER WHITE  BRILLIANT CELLS FULL SPECTRUM BRIGHTENING UV PROTECTOR SPF 50
homosalate, octisalate, avobenzone, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-006-01	1 in 1 CARTON
1	NDC: 11559-006-02	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2010

Labeler - ESTEE LAUDER INC (005914387)

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

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

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

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

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

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

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

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

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

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

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

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

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