HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE- octinoxate and titanium dioxide liquid

HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE by

Drug Labeling and Warnings

HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE 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 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 4.90%

Titanium Dioxide 2.90%

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
• 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, Polymethyl Methacrylate, Trioctyldodecyl Citrate, Polysilicone-11, Coco-Caprylate/Caprate, PEG/PPG-18/18 Dimethicone, Polyglyceryl-4 Isostearate, Sodium Hyaluronate, Ascorbyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Quaternium-90 Bentonite, Dimethicone Silylate, Magnesium Aluminum Silicate, Alumina, Silica, Propylene Carbonate, Sodium Chloride, Caprylyl Glycol, Hexylene Glycol, Stearic Acid, Palmitic Acid, C12-16 Alcohols, Hydrogenated Lecithin, Disodium EDTA, Phenoxyethanol, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)] <ILN39852>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

smashbox

LIQUID
HALO
HD FOUNDATION

BROAD SPECTRUM
SPF 15
OIL-FREE

1 fl. oz./30 ml e

INGREDIENTS AND APPEARANCE

HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05635 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.03335 g  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)
Trioctyldodecyl Citrate (UNII: 35X8CT063R)
Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Aluminum Oxide (UNII: LMI26O6933)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Propylene Carbonate (UNII: 8D08K3S51E)
Sodium Chloride (UNII: 451W47IQ8X)
Caprylyl Glycol (UNII: 00YIU5438U)
Hexylene Glycol (UNII: KEH0A3F75J)
Stearic Acid (UNII: 4ELV7Z65AP)
Palmitic Acid (UNII: 2V16EO95H1)
C12-16 Alcohols (UNII: S4827SZE3L)
Edetate Disodium (UNII: 7FLD91C86K)
Phenoxyethanol (UNII: HIE492ZZ3T)
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: 10348-010-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/01/2013

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(10348-010) , REPACK(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(10348-010) , RELABEL(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(10348-010) , RELABEL(10348-010) , REPACK(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(10348-010)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(10348-010) , RELABEL(10348-010)