ESIKA  MAXIMUM COLOR LIPSTICK SPF 18- octinoxate and oxybenzone lipstick 
Ventura Corporation LTD.

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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ēsika Maximum Color Lipstick SPF 18

Drug Facts

Active Ingredients

Octinoxate 7.3 %, Oxybenzone 1.65%

Purpose

Sunscreen

Uses

Warnings

  • Do not use on damage 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive Ingredients

diisopropyl dimer dilinoleate, ethylhexyl palmitate, ozokerite, copernicia cerifera (carnauba) wax, polyethylene, butyrospermum parkii (shea) butter, silica, octyldodecanol, water, phenoxyethanol, microcrystalline wax, petrolatum, phospholipids, methylparaben, fragrance, bht, cholesterol, butylparaben, ethylparaben, euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, propylparaben, glycosphingolipids, maltodextrin, zea mays (corn) starch, sodium hyaluronate. May contain: red 7 lake, red 27 lake, iron oxides, mica, yellow 5 lake, titanium dioxide, red 6 lake, isononyl isononanoate, talc, isopropyl myristate, blue 1 lake, carmine, isopropyl titanium triisostearate, triethoxycaprylylsilane, stearalkonium hectorite, C9-15 fluoroalcohol phosphate, polyhydroxystearic acid, propylene carbonate.

Dist. by Ventura Corporation, Ltd.
San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Carton
ESIKA   MAXIMUM COLOR LIPSTICK SPF 18
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-442
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0165 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
diisopropyl dilinoleate (UNII: 5323S7S2LR)  
ethylhexyl palmitate (UNII: 2865993309)  
carnauba wax (UNII: R12CBM0EIZ)  
high density polyethylene (UNII: UG00KM4WR7)  
shea butter (UNII: K49155WL9Y)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
octyldodecanol (UNII: 461N1O614Y)  
water (UNII: 059QF0KO0R)  
phenoxyethanol (UNII: HIE492ZZ3T)  
microcrystalline wax (UNII: XOF597Q3KY)  
petrolatum (UNII: 4T6H12BN9U)  
methylparaben (UNII: A2I8C7HI9T)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
cholesterol (UNII: 97C5T2UQ7J)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
propylparaben (UNII: Z8IX2SC1OH)  
maltodextrin (UNII: 7CVR7L4A2D)  
starch, corn (UNII: O8232NY3SJ)  
hyaluronate sodium (UNII: YSE9PPT4TH)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
mica (UNII: V8A1AW0880)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
titanium dioxide (UNII: 15FIX9V2JP)  
D&C RED NO. 6 (UNII: 481744AI4O)  
isononyl isononanoate (UNII: S4V5BS6GCX)  
talc (UNII: 7SEV7J4R1U)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)  
triethoxycaprylylsilane (UNII: LDC331P08E)  
propylene carbonate (UNII: 8D08K3S51E)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-442-021 in 1 BOX
1NDC:13537-442-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/06/2012
Labeler - Ventura Corporation LTD. (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-442)
Establishment
NameAddressID/FEIBusiness Operations
Yobel Supply Chain Management S.A. (Peru)934116930MANUFACTURE(13537-442)

Revised: 12/2012
Document Id: 4d4265eb-7fd5-4e3c-9212-d5832bbbba4d
Set id: 86a34dea-7244-446e-8fa8-3fc11aa7a33a
Version: 1
Effective Time: 20121208
 
Ventura Corporation LTD.