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SMASHBOX

SMASHBOX BEAUTY COSMETICS, INC

SMASHBOX HIGH DEFINITION HEALTHY FX FOUNDATION SPF 15


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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)]

SMASHBOX Other information

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

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

SMASHBOX

SMASHBOX

OCTINOXATE and TITANIUM DIOXIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10348-005
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 5 mL
titanium dioxide 3.2 mL

Inactive Ingredients

Ingredient Name Strength
water
ISODODECANE
CYCLOMETHICONE 5
DIMETHICONE
BUTYLENE GLYCOL
PEG/PPG-18/18 DIMETHICONE
HEXYL LAURATE
POLYGLYCERYL-4 ISOSTEARATE
PROPYLENE CARBONATE
ASCORBYL PALMITATE
ALUMINUM OXIDE
SILICON DIOXIDE
magnesium aluminum silicate
SODIUM CHLORIDE
CAPRYLYL GLYCOL
STEARIC ACID
PALMITIC ACID
C12-16 ALCOHOLS
EDETATE DISODIUM
PHENOXYETHANOL
SODIUM DEHYDROACETATE
MICA
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-01-01


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