SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER- octinoxate and octisalate lotion

smashbox by

Drug Labeling and Warnings

smashbox by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, INC, ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, MANA Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)].

PURPOSE

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

SMASHBOX   PHOTO FINISH SPF 15 FOUNDATION PRIMER
octinoxate and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-004-01	1 in 1 CARTON
1		30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2011

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC Kabushiki Kaisha		712808195	RELABEL(10348-004) , REPACK(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
ARAMIS, INC		042918826	MANUFACTURE(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(10348-004) , RELABEL(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		787336577	MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		949264774	MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		618107429	MANUFACTURE(10348-004) , RELABEL(10348-004) , REPACK(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(10348-004)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Cosmetics Inc		078870292	MANUFACTURE(10348-004)