SMASHBOX HIGH DEFINITION HEALTHY FX FOUNDATION SPF 15

Dosage form: liquid
Ingredients: OCTINOXATE 5mL in 100mL, TITANIUM DIOXIDE 3.2mL in 100mL
Labeler: SMASHBOX BEAUTY COSMETICS, INC
NDC Code: 10348-005

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SMASHBOX
HIGH DEFINITION HEALTHY FX FOUNDATION SPF 15

Drug Facts

Active IngredientsPurpose
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

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   HIGH DEFINITION HEALTHY FX FOUNDATION SPF 15
octinoxate and titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3.2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:10348-005-011 CYLINDER (CYLINDER) in 1 CARTON
130 mL in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2012
Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195RELABEL(10348-005), REPACK(10348-005)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(10348-005), RELABEL(10348-005), REPACK(10348-005)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(10348-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(10348-005), RELABEL(10348-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(10348-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(10348-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(10348-005)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(10348-005)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(10348-005)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(10348-005), RELABEL(10348-005), REPACK(10348-005)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(10348-005), RELABEL(10348-005), REPACK(10348-005)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(10348-005), RELABEL(10348-005), REPACK(10348-005)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(10348-005)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(10348-005)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(10348-005), RELABEL(10348-005)
Establishment
NameAddressID/FEIOperations
NU-WORLD CORPORATION628045858MANUFACTURE(10348-005)

Revised: 03/2012
 
SMASHBOX BEAUTY COSMETICS, INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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