SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25- octinoxate, titanium dioxide, and zinc oxide liquid

SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25 by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, INC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 6.7%
Titanium Dioxide 3.1%
Zinc Oxide 1.3%

Purpose

Sunscreen

Uses

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, Octyldodecyl Neopentanoate, Butyloctyl Salicylate, Dimethicone, Butylene Glycol, Methyl Trimethicone, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-9 Polydimethyl-siloxyethyl Dimethicone, Diethylhexyl Succinate, Laureth-4, Tocopheryl Acetate, Sodium Hyaluronate, Lecithin, Rosa Hybrid Flower Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lycium Chinense (Wolfberry) Fruit Extract, Palmitoyl Hexapeptide-14, Peat Extract, Gold, Sodium Lactate, Methicone, Sodium PCA, Hydrolyzed Wheat Protein/PVP Crosspolymer, Glycerin, Barium Sulfate, Magnesium Sulfate, Dimethyl Isosorbide, Maltodextrin, Triethoxycaprylylsilane, Dimethicone Crosspolymer-3, Silica, Aluminum Hydroxide, Dimethicone/PEG-10/15 Crosspolymer, Trimethylsiloxysilicate, Hexylene Glycol, Isostearic Acid, Caprylyl Glycol, Stearic Acid, Polyglyceryl-2 Triisostearate, Dipentaerythrityl Tri-Polyhydroxystearate, Dipropylene Glycol, Sodium Citrate, BHT, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Bismuth Oxychloride (CI 77163)] <ILN48115>

Other Information

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

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

smashbox
HALO

HEALTHY GLOW
ALL-IN-ONE
TINTED MOISTURIZER
BROAD SPECTRUM SPF 25

1.4 fl. oz./ 40 ml ℮

INGREDIENTS AND APPEARANCE

SMASHBOX HALO HEALTHY GLOW ALL-IN-ONE TINTED MOISTURIZER BROAD SPECTRUM SPF 25 
octinoxate, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Methyl Trimethicone (UNII: S73ZQI0GXM)
Niacinamide (UNII: 25X51I8RD4)
Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)
Diethylhexyl Succinate (UNII: 69W9UMG3P8)
Laureth-4 (UNII: 6HQ855798J)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Apple (UNII: B423VGH5S9)
Lens Culinaris Fruit (UNII: ZYZ076G9JH)
Watermelon (UNII: 231473QB6R)
Gold (UNII: 79Y1949PYO)
Sodium Lactate (UNII: TU7HW0W0QT)
Methicone (20 Cst) (UNII: 6777U11MKT)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Glycerin (UNII: PDC6A3C0OX)
Barium Sulfate (UNII: 25BB7EKE2E)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Dimethyl Isosorbide (UNII: SA6A6V432S)
Maltodextrin (UNII: 7CVR7L4A2D)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Hexylene Glycol (UNII: KEH0A3F75J)
Isostearic Acid (UNII: X33R8U0062)
Caprylyl Glycol (UNII: 00YIU5438U)
Stearic Acid (UNII: 4ELV7Z65AP)
Polyglyceryl-2 Triisostearate (UNII: 68DUY2D39A)
Dipentaerythrityl Tri-Polyhydroxystearate (UNII: D21K655H52)
Dipropylene Glycol (UNII: E107L85C40)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Sodium Benzoate (UNII: OJ245FE5EU)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Mica (UNII: V8A1AW0880)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)
Bismuth Oxychloride (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-018-01	1 in 1 CARTON	04/02/2020
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/02/2020

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(10348-018) , REPACK(10348-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(10348-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-018)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-018)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(10348-018) , REPACK(10348-018)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(10348-018) , REPACK(10348-018)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(10348-018)