VIRTUAL SKIN SUPER NATURAL FINISH SPF 10- octinoxate liquid

VIRTUAL SKIN by

Drug Labeling and Warnings

VIRTUAL SKIN by is a Otc medication manufactured, distributed, or labeled by PRESCRIPTIVES INC., Len-Ron Manufacturing Division of Aramis Inc., Estee Lauder Inc, Northtec Keystone, Northtec Bristol, Estee Lauder Pennsylvania Distribution Center 2, Estee Lauder Cosmetics Ltd., Estee Lauder Cosmetics, Ltd., Estee Lauder Cosmetics Distribution Centre, ELGC K.K., Estee Lauder N.V., Whitman Laboratories Ltd., Aveda Corporation, Pennsylvania Logistics Center (PALC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: OCTINOXATE 5.40%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER\AQUA\EAU [] DIMETHICONE [] CYCLOPENTASILOXANE [] GLYCERYL STEARATE SE [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] BUTYLENE GLYCOL [] TALC [] CHOLESTEROL [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] MELANIN [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] POLYACRYLAMIDE [] ETHYLHEXYLGLYCERIN [] PALMITIC ACID [] C13-14 ISOPARAFFIN [] CAPRYLYL GLYCOL [] LAURETH-7 [] HEXYLENE GLYCOL [] LINOLEIC ACID [] PEG-9 DIMETHICONE [] SILICA [] CITRIC ACID [] SODIUM CITRATE [] DISODIUM EDTA [] SORBIC ACID [] BENZOIC ACID [] POTASSIUM SORBATE [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA

WARNINGS

WARNINGS: FOR EXTERNAL USE ONLY. KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF SKIN RASH OR IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

PRINCIPAL DISPLAY PANEL

PRESCRIPTIVES
VIRTUAL SKIN
SUPER NATURAL FINISH
SPF 10

1.0 FL OZ LIQ/ 30 ML


PRESCRIPTIVES CO. DIST
NY NY 10022

INGREDIENTS AND APPEARANCE

VIRTUAL SKIN   SUPER NATURAL FINISH SPF 10
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59158-759
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WHEAT BRAN (UNII: 6L966A1IMR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BLACK OLIVE (UNII: 2M6QWV94OC)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PALMITIC ACID (UNII: 2V16EO95H1)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LAURETH-7 (UNII: Z95S6G8201)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59158-759-01	1 in 1 CARTON
1	NDC: 59158-759-02	30 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/1999

Labeler - PRESCRIPTIVES INC. (151701588)

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

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc		042918826	manufacture

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

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		959338336	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		943871157	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.		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		244669714	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 Centre		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder N.V.		370151326	manufacture

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center (PALC)		078364654	repack, relabel