DAYWEAR BB ANTI OXIDANT BEAUTY BENEFIT SPF 35 - octinoxate, octisalate, oxybenzone and titanium dioxide cream
ESTEE LAUDER INC

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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ACTIVE INGREDIENTS

OCTINOXATE 7.50% ∙ OCTISALATE 4.00% ∙ OXYBENZONE 2.50% ∙ TITANIUM DIOXIDE 1.10%

INGREDIENTS

WATER • DIMETHICONE • BUTYLENE GLYCOL • PENTYLENE GLYCOL • PHENYL TRIMETHICONE • GLYCERYL STEARATE • BEHENYL ALCOHOL • TRIOCTYLDODECYL CITRATE • POLYMETHYLSILSESQUIOXANE • OCTYLDODECYL STEAROYL STEARATE • PEG-40 STEARATE • POLYGLYCERYL-10 PENTASTEARATE • GENTIANA LUTEA (GENTIAN) ROOT EXTRACT • POLYGONUM CUSPIDATUM ROOT EXTRACT • THERMUS THERMOPHILLUS FERMENT • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT • CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT • HYDROLYZED RICE BRAN EXTRACT • LAMINARIA SACCHARINA EXTRACT • HYDROLYZED RICE EXTRACT • ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT • ARTEMIA EXTRACT • VITIS VINIFERA (GRAPE) SEED EXTRACT • TRITICUM VULGARE (WHEAT) GERM EXTRACT • CHOLESTEROL • CAFFEINE • PROPY LENE GLYCOL STEARATE • OCTYLDODECYL NEOPENTANOATE • POLYGLYCERYL-6 POLYRICINOLEATE • TOCOPHERYL ACETATE • SUCROSE • GLYCERINE • SODIUM STEAROYL LACTYLATE • LINOLEIC ACID • LECITHIN • SQUALANE • SODIUM PCA • UREA • ISOPROPYL TITANIUM TRIISOSTEARATE • ERGOTHIONEINE • SODIUM DEHYDROACETATE • TETRAHEXYLDECYL ASCORBATE • POLYSORBATE 20 • SORBITAN LAURATE • SODIUM HYALURONATE • CITRIC ACID • PROPYLENE GLYCOL LAURATE • GLYCYRRHETINIC ACID • TREHALOSE • POLYQUATERNIUM-51 • HYDROGENATED LECITHIN • FUMARIC ACID • ALUMINA • PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • CYCLODEXTRIN • NORDIHYDROGUAIARETIC ACID • ASCORBYL TOCOPHERYL MALEATE • XANTHAN GUM • STEARIC ACID • SILICA • FRAGRANCE • ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE • PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE • DISODIUM EDTA • PHENOXYETHANOL • CHLORPHENESIN • [+/- TITANIUM DIOXIDE (CI 77891) • ZINC OXIDE (CI 77947) • IRON OXIDES (CI 77491, CI 77492, CI 77499) • YELLOW 5 LAKE (CI 19140) • CHROMIUM OXIDE GREENS (CI 77288) • MICA • FERRIC FERROCYANIDE (CI 77510) • CHROMIUM HYDROXIDE GREEN (CI 77289) • CARMINE (CI 75470) • BISMUTH OXYCHLORIDE (CI 77163) • BLUE 1 LAKE (CI 42090)] <ILN38365>

WARNING

Keep out of eyes. Stop use if irritation occurs. Keep out of reach of children.

PRINCIPAL DISPLAY PANEL - 30 ml carton

ESTĒE LAUDER

DayWear

B•B

Anti-Oxidant
Beauty Benefit Creme

SPF 35

All Skintypes

1 FL. OZ. LIQ./30 ml e

DAYWEAR BB ANTI OXIDANT BEAUTY BENEFIT SPF 35
octinoxate, octisalate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11559-015
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	7.5 mL in 100 mL
OCTISALATE (OCTISALATE)	OCTISALATE	4 mL in 100 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	2.5 mL in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	1.1 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
DIMETHICONE
BUTYLENE GLYCOL
PENTYLENE GLYCOL
PHENYL TRIMETHICONE
GLYCERYL MONOSTEARATE
DOCOSANOL
OCTYLDODECYL STEAROYL STEARATE
PEG-40 STEARATE
GENTIANA LUTEA ROOT
POLYGONUM CUSPIDATUM ROOT
HORDEUM VULGARE ROOT
FUMARIA OFFICINALIS FLOWERING TOP
LEMON
SACCHARINA LATISSIMA THALLUS
ROSEMARY
VITIS VINIFERA SEED
WHEAT GERM
CHOLESTEROL
CAFFEINE
PROPYLENE GLYCOL STEARATE
OCTYLDODECYL NEOPENTANOATE
ALPHA-TOCOPHEROL ACETATE
SUCROSE
GLYCERIN
SODIUM STEAROYL LACTYLATE
LINOLEIC ACID
SQUALANE
SODIUM PYRROLIDONE CARBOXYLATE
UREA
ERGOTHIONEINE
SODIUM DEHYDROACETATE
TETRAHEXYLDECYL ASCORBATE
POLYSORBATE 20
SORBITAN MONOLAURATE
HYALURONATE SODIUM
CITRIC ACID MONOHYDRATE
PROPYLENE GLYCOL LAURATES
ENOXOLONE
TREHALOSE
FUMARIC ACID
ALUMINUM OXIDE
MASOPROCOL
XANTHAN GUM
STEARIC ACID
SILICON DIOXIDE
EDETATE DISODIUM
PHENOXYETHANOL
CHLORPHENESIN
ZINC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
FD&C YELLOW NO. 5
CHROMIC OXIDE
MICA
FERRIC FERROCYANIDE
COCHINEAL
BISMUTH OXYCHLORIDE
FD&C BLUE NO. 1

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:11559-015-01	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		30 mL in 1 BOTTLE	This package is contained within the CARTON (11559-015-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2011

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Operations
ELGC Kabushiki Kaisha		712808195	RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
ARAMIS, INC		042918826	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE

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

Establishment
Name	Address	ID/FEI	Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
NORTEC KEYSTONE		787336577	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Aveda Corporation		071352058	MANUFACTURE

Revised: 12/2011 ESTEE LAUDER INC