ACTIVE INGREDIENTS: HOMOSALATE 5.00% [] OCTINOXATE 5.00% [] AVOBENZONE 3.00%

INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] BUTYLENE GLYCOL [] JOJOBA ESTERS [] VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER [] PEG-12 GLYCERYL DIMYRISTATE [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] PEG-100 STEARATE [] HYPNEA MUSCIFORMIS (ALGAE) EXTRACT [] GELLIDIELA ACEROSA (ALGAE) EXTRACT [] SALVIA SCLAREA (CLARY) EXTRACT [] LYCIUM CHINENSE (WOLFBERRY) FRUIT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] VITIS VINIFERA (GRAPE) FRUIT EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] MORUS BOMBYCIS (MULBERRY) ROOT EXTRACT [] ASTROCARYUM MURUMURU SEED BUTTER [] HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE [] FISH (PISCES) COLLAGEN [] SUCROSE [] CAFFEINE [] POLYETHYLENE [] LINOLENIC ACID [] GLYCERIN [] LINOLEIC ACID [] SODIUM HYALURONATE [] POLYSORBATE 40 [] PENTAERYTHRITYL TETRAISOSTEARATE [] GLYCERYL STEARATE [] POLYSILICONE-11 [] PROPYLENE GLYCOL DICAPRATE [] ISOHEXADECANE [] OCTOCRYLENE [] ACETYL GLUCOSAMINE [] CETYL ALCOHOL [] STEARETH-21 [] TOCOPHERYL ACETATE [] POLYSORBATE 80 [] ACETYL HEXAPEPTIDE-8 [] CAPRYLYL GLYCOL [] 1,2-HEXANEDIOL [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] HYDROGENATED LECITHIN [] MALTODEXTRIN [] TREHALOSE [] SODIUM CHONDROITIN SULFATE [] SILICA DIMETHYL SILYLATE [] HEXYLENE GLYCOL [] FRAGRANCE (PARFUM) [] DISODIUM EDTA [] LINALOOL [] CITRONELLOL [] LIMONENE [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL

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

PRINCIPAL DISPLAY PANEL:

PX

PRESCRIPTIVES

ALL YOU NEED + SPF 15

CONTINUOUS MOISTURE

24 HOUR MOISTURE FOR NORMAL SKIN

1.7 FL OZ/OZ LIQ/50 ML

PRESCRIPTIVES CO. DISTR
NEW YORK, NY 10022

folding carton

ALL YOU NEED CONTINUOUS ACTION 24 HOUR MOISTURE SPF 15 FOR NORMAL SKIN
homosalate, octinoxate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59158-719
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5.0 mL in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mL in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)
PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)
YEAST (UNII: 3NY3SM6B8U)
PEG-100 STEARATE (UNII: YD01N1999R)
HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)
GELIDIELLA ACEROSA (UNII: T91K54D6M1)
CLARY SAGE (UNII: U3HSK5JC0Q)
LYCIUM CHINENSIS FRUIT (UNII: TG711Q7A1Q)
BARLEY (UNII: 5PWM7YLI7R)
WINE GRAPE (UNII: 3GOV20705G)
CUCUMBER (UNII: YY7C30VXJT)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
MORUS AUSTRALIS ROOT (UNII: 1VL55O45RF)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
SUCROSE (UNII: C151H8M554)
CAFFEINE (UNII: 3G6A5W338E)
LINOLENIC ACID (UNII: 0RBV727H71)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYSORBATE 40 (UNII: STI11B5A2X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
ISOHEXADECANE (UNII: 918X1OUF1E)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-21 (UNII: 53J3F32P58)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TREHALOSE (UNII: B8WCK70T7I)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description
Packaging
1	NDC:59158-719-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/01/2007

Labeler - PRESCRIPTIVES INC. (151701588)

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