ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] TITANIUM DIOXIDE 3.00%

INGREDIENTS: WATER [] PHENYL TRIMETHICONE [] BUTYLENE GLYCOL [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] PETROLATUM [] BIOSACCHARIDE GUM - 1 [] STEARETH-21 [] GLYCERYL STEARATE [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] POLYMETHYL METHACRYLATE [] MAGNESIUM ALUMINUM SILICATE [] ETHYLHEXYLGLYCERIN [] CAPRYLYL GLYCOL [] CETYL ALCOHOL [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] PEG-12 DIMETHICONE [] ISOHEXADECANE [] LECITHIN [] ALUMINA [] XANTHAN GUM [] STEARETH-2 [] POTASSIUM STEARATE [] CITRIC ACID [] FRAGRANCE (PARFUM) [] LIMONENE [] LINALOOL [] BENZYL SALICYLATE [] POLYSORBATE 80 [] DISODIUM EDTA [] PHENOXYETHANOL [] SORBIC ACID [] [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)

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

PRINCIPAL DISPLAY PANEL:

AMERICAN
BEAUTY

YOUTH-FULL

SHEER COLOR

TINTED MOISTURIZER

SPF 15

NT WT 1.7 OZ./ 50 ML

AMERICAN BEAUTY COSMETICS, DIST
NEW YORK, NY 10022

YOUTH FULL TINTED MOISTURIZER SPF 15
octinoxate, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68759-003
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
JOJOBA OIL (UNII: 724GKU717M)
PETROLATUM (UNII: 4T6H12BN9U)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
STEARETH-21 (UNII: 53J3F32P58)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOHEXADECANE (UNII: 918X1OUF1E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALUMINUM OXIDE (UNII: LMI26O6933)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARETH-2 (UNII: V56DFE46J5)
POTASSIUM STEARATE (UNII: 17V812XK50)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description
Packaging
1	NDC:68759-003-01	1 in 1 CARTON
1	NDC:68759-003-02	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	11/01/2010

Labeler - AMERICAN BEAUTY COSMETICS (143367634)

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
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	repack, 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