SMASHBOX PHOTO FINISH FOUNDATION PRIMER SPF 20- avobenzone, homosalate, and octisalate liquid

SMASHBOX by

Drug Labeling and Warnings

SMASHBOX by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, INC, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder 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, Pennsylvania Logistics Center, MANA Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 2.00%
Homosalate 15.00%
Octisalate 5.00%

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:

• apply liberally and evenly 15 minutes before sun exposure
• apply to all skin exposed to the sun
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive Ingredients

Cyclopentasiloxane, Polysilicone-11, Dimethicone Crosspolymer, C12-15 Alkyl Benzoate, Tocopheryl Acetate, Cola Acuminata (Kola) Seed Extract, Vitis Vinifera (Grape) Seed Extract, Carthamus Tinctorius (Safflower) Seed Oil, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Octyldodecyl Neopentanoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Acetyl Hexapeptide-8, Phenyl Trimethicone, Water\Aqua\Eau, Silica, Laureth-12, Hexyl Laurate, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Caprylyl Glycol, Hexylene Glycol, Hydrogenated Polydecene, Phenoxyethanol, Potassium Sorbate, Iron Oxides (CI 77491) <ILN39369>

Other information

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

SPL UNCLASSIFIED SECTION

Smashbox Cosmetics, Dist.
Culver City, CA 90232

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

smashbox

PHOTO FINISH
FOUNDATION PRIMER

SPF 20
WITH DERMAXYL™ COMPLEX

BROAD SPECTRUM SPF 20
1 fl. oz. / 30 ml e

INGREDIENTS AND APPEARANCE

SMASHBOX   PHOTO FINISH FOUNDATION PRIMER SPF 20
avobenzone, homosalate, and octisalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 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)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
cola acuminata seed (UNII: 1F8VIW1479)
Vitis Vinifera Seed (UNII: C34U15ICXA)
Safflower Oil (UNII: 65UEH262IS)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Tribehenin (UNII: 8OC9U7TQZ0)
Ceramide 2 (UNII: C04977SRJ5)
PEG-10 Rapeseed Sterol (UNII: 258O76T85M)
Palmitoyl Oligopeptide (UNII: HO4ZT5S86C)
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Laureth-12 (UNII: OAH19558U1)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Caprylyl Glycol (UNII: 00YIU5438U)
Hexylene Glycol (UNII: KEH0A3F75J)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-006-01	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2012

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(10348-006) , REPACK(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(10348-006) , RELABEL(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(10348-006) , RELABEL(10348-006)

Establishment
Name	Address	ID/FEI	Business Operations
MANA Cosmetics Inc		078870292	MANUFACTURE(10348-006)