SMASHBOX HIGH DEFINITION HEALTHY FX FOUNDATION SPF 15- octinoxate and titanium dioxide 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, NU-WORLD CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 5.00%	Sunscreen
Titanium Dioxide 3.20%	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
• 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

Water\Aqua\Eau, Isododecane, Cyclopentasiloxane, Dimethicone, Butylene Glycol, PEG/PPG-18/18 Dimethicone, Polysilicone-11, Coco-Caprylate/Caprate, Quaternium-90 Bentonite, Hexyl Laurate, Polyglyceryl-4 Isostearate, Propylene Carbonate, Dimethicone/Divinyldimethicone Silsesquioxane Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Ascorbyl Palmitate, PEG-10 Dimethicone, Alumina, Silica, Magnesium Aluminum Silicate, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Sodium Chloride, Caprylyl Glycol, Stearic Acid, Palmitic Acid, C12-16 Alcohols, Hydrogenated Lecithin, Disodium EDTA, Phenoxyethanol, Sodium Dehydroacetate, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)] <ILN38702>

Other information

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30ml Cylinder Carton

smashbox

HIGH DEFINITION
HEALTHY FX FOUNDATION
SPF 15

OIL-FREE

BROAD SPECTRUM SPF 15
1 fl. oz. / 30ml e

INGREDIENTS AND APPEARANCE

SMASHBOX   HIGH DEFINITION HEALTHY FX FOUNDATION SPF 15
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
C12-16 ALCOHOLS (UNII: S4827SZE3L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-005-01	1 in 1 CARTON
1		30 mL in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2012

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(10348-005) , REPACK(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(10348-005) , RELABEL(10348-005) , REPACK(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(10348-005) , RELABEL(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(10348-005) , RELABEL(10348-005) , REPACK(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(10348-005) , RELABEL(10348-005) , REPACK(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(10348-005) , RELABEL(10348-005) , REPACK(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(10348-005) , RELABEL(10348-005)

Establishment
Name	Address	ID/FEI	Business Operations
NU-WORLD CORPORATION		628045858	MANUFACTURE(10348-005)