SMASHBOX  PHOTO FINISH SPF 15 FOUNDATION PRIMER- octinoxate and octisalate lotion 
SMASHBOX BEAUTY COSMETICS, 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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smashbox
PHOTO FINISH SPF 15 FOUNDATION PRIMER

Directions

Apply evenly to face prior to sun exposure. Children under 6 months of age: ask doctor.

Sun Alert

The sun may cause sunburn, premature aging of skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

WARNING

Keep out of eyes.

Stop using if irritation occurs.

If irritation persists, consult a health care practitioner.

Keep out of reach of children.

Apply before sun exposure.

ACTIVE INGREDIENTS

7.5% Octinoxate, 5.0% Octisalate.

INACTIVE INGREDIENTS

Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethyl Perfluoroisobutyl Ether, Ethyl Perfluorobutyl Ether, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Cola Acuminata Seed Extract, Camellia Oleifera Leaf Extract, Vitis Vinifera (Grape) Seed Extract, C12-15 Alkyl Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Tocophenyl Acetate, Retinyl Palmitate, Water/Aqua/Eau, Ethyl Trisiloxane, Caprylyl Methicone, Methicone, Silica, Silica Silylate, Hexylene Glycol, Propylene Glycol, Triethoxycaprylylsilane, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol [+/- Iron Oxides (CI77491), Titanium Dioxide (CI77891)].

Drug Facts

Warnings

For external use only.

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Rash or irritation develops and lasts.

Keep out of reach of children.

Dist. Smashbox Beauty
Cosmetics, Inc.
Culver City, CA 90232

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

smashbox

PHOTO FINISH
SPF 15

WITH DERMAXYL™ COMPLEX

FOUNDATION PRIMER
SPF 15 ET DERMAXYL™

1 fl. oz./30ml e

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
SMASHBOX   PHOTO FINISH SPF 15 FOUNDATION PRIMER
octinoxate and octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Diethylamino Hydroxybenzoyl Hexyl Benzoate (UNII: ANQ870JD20)  
Safflower Oil (UNII: 65UEH262IS)  
Cola Acuminata Seed (UNII: 1F8VIW1479)  
Camellia Oleifera Leaf (UNII: 5077EL0C60)  
Vitis Vinifera Seed (UNII: C34U15ICXA)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Tribehenin (UNII: 8OC9U7TQZ0)  
Ceramide 2 (UNII: C04977SRJ5)  
PEG-10 Rapeseed Sterol (UNII: 258O76T85M)  
Palmitoyl Oligopeptide (UNII: HO4ZT5S86C)  
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Water (UNII: 059QF0KO0R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Hexylene Glycol (UNII: KEH0A3F75J)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10348-004-011 in 1 CARTON
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/2011
Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
Establishment
NameAddressID/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL(10348-004) , REPACK(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(10348-004) , RELABEL(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(10348-004)
Establishment
NameAddressID/FEIBusiness Operations
MANA Cosmetics Inc078870292MANUFACTURE(10348-004)

Revised: 1/2012
Document Id: 914e2639-b8ad-40a3-9843-035cfab7f440
Set id: afb9b34d-3107-45e2-ba68-9a991c09e622
Version: 1
Effective Time: 20120123
 
SMASHBOX BEAUTY COSMETICS, INC