PRESCRIPTIVES  SITE UNSEEN BRIGHTENING CONCEALER BROAD SPECTRUM SPF 15- octinoxate, titanium dioxide, and zinc oxide 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.

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PRESCRIPTIVES
Site Unseen Brightening Concealer Broad Spectrum SPF 15

Drug Facts

Active ingredients

Octinoxate 4.10%
Titanium Dioxide 1.40%
Zinc Oxide 1.50%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

Inactive ingredients

water\aqua\eau • cyclopentasiloxane • dimethicone • phenyl trimethicone • dimethicone silylate • butylene glycol • peg/ppg-18/18 dimethicone • silica • yeast extract\faex\extrait de levure • ethylhexylglycerin • octyldodecyl neopentanoate • tocopheryl acetate • triethoxycaprylylsilane • glycerin • polysilicone-11 • magnesium sulfate • disteardimonium hectorite • dipeptide-2 • palmitoyl tetrapeptide-7 • sorbitan sesquioleate • acetyl hexapeptide-8 • polyglyceryl-6 polyricinoleate • laureth-7 • isopropyl titanium triisostearate • propylene carbonate • chamomilla recutita (matricaria) • hesperidin methyl chalcone • steareth-20 • alumina • chloroxylenol • phenoxyethanol • [+/- titanium dioxide (ci 77891) • mica • iron oxides (ci 77491, ci 77492, ci 77499)] <iln32488>

Other information

protect the product in this container from excessive heat and direct sun

DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 3.5 ml Carton

PRESCRIPTIVES
Site Unseen
Brightening Concealer Broad Spectrum SPF 15
0.12 FL. OZ./OZ. LIQ./3.5 ml

PRINCIPAL DISPLAY PANEL - 3.5 ml Carton
PRESCRIPTIVES   SITE UNSEEN BRIGHTENING CONCEALER BROAD SPECTRUM SPF 15
octinoxate, titanium dioxide, and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-913
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE.04551 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE.01554 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.01665 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
YEAST (UNII: 3NY3SM6B8U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
LAURETH-7 (UNII: Z95S6G8201)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X)  
STEARETH-20 (UNII: L0Q8IK9E08)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59158-913-011 in 1 CARTON
13.5 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35211/16/2006
Labeler - PRESCRIPTIVES INC. (151701588)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(59158-913) , REPACK(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59158-913) , RELABEL(59158-913) , REPACK(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59158-913) , RELABEL(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(59158-913) , RELABEL(59158-913) , REPACK(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(59158-913) , RELABEL(59158-913) , REPACK(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(59158-913) , RELABEL(59158-913) , REPACK(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(59158-913)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(59158-913) , RELABEL(59158-913)

Revised: 11/2012
Document Id: 32cbe570-53c5-4835-a17c-8cea24909895
Set id: d0f13a8f-bfe1-475c-b001-ae1d1274a633
Version: 1
Effective Time: 20121115
 
PRESCRIPTIVES INC.