OTC Labels

Over the Counter Medications

OTC Medication Information: VIRTUAL SKIN SUPER NATURAL FINISH SPF 10

By PRESCRIPTIVES INC. | Last revised: 24 April 2012

VIRTUAL SKIN SUPER NATURAL FINISH SPF 10- octinoxate liquid
PRESCRIPTIVES 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.

ACTIVE INGREDIENT: OCTINOXATE 5.40%

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: 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.

PRESCRIPTIVES
VIRTUAL SKIN
SUPER NATURAL FINISH
SPF 10
1.0 FL OZ LIQ/ 30 ML
PRESCRIPTIVES CO. DIST
NY NY 10022

FOLDING CARTON
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 5.4 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
CYCLOMETHICONE 5
GLYCERYL MONOSTEARATE
BUTYLENE GLYCOL
TALC
CHOLESTEROL
WHEAT BRAN
HYALURONATE SODIUM
ALPHA-TOCOPHEROL ACETATE
BLACK OLIVE
POLYACRYLAMIDE (10000 MW)
PALMITIC ACID
C13-14 ISOPARAFFIN
CAPRYLYL GLYCOL
LAURETH-7
HEXYLENE GLYCOL
LINOLEIC ACID
SILICON DIOXIDE
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
SORBIC ACID
POTASSIUM SORBATE
PHENOXYETHANOL
TITANIUM DIOXIDE
FERRIC OXIDE RED
MICA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59158-759-01 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC (59158-759-02)
1 NDC:59158-759-02 30 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59158-759-01)
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 Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Inc 042918826 manufacture
Establishment
Name Address ID/FEI Operations
Northtec Keystone 949264774 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Northtec Bristol 959338336 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Northtec Keystone 943871157 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Ltd. 205952385 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd. 244669714 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd. 253616536 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Distribution Centre 208579636 repack, relabel
Establishment
Name Address ID/FEI Operations
ELGC K.K. 712808195 relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder N.V. 370151326 manufacture
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture
Establishment
Name Address ID/FEI Operations
Aveda Corporation 071352058 manufacture
Establishment
Name Address ID/FEI Operations
Pennsylvania Logistics Center (PALC) 078364654 repack, relabel

Revised: 04/2012 PRESCRIPTIVES INC.

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