SMASHBOX PHOTO FINISH FOUNDATION PRIMER SPF 20

Dosage form: liquid
Ingredients: AVOBENZONE 2mL in 100mL, HOMOSALATE 15mL in 100mL, OCTISALATE 5mL in 100mL
Labeler: SMASHBOX BEAUTY COSMETICS, INC
NDC Code: 10348-006

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 PHOTO FINISH FOUNDATION PRIMER SPF 20

Drug Facts

Active Ingredients

Avobenzone 2.00%
Homosalate 15.00%
Octisalate 5.00%

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
  • apply to all skin exposed to the sun
  • 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

Cyclopentasiloxane, Polysilicone-11, Dimethicone Crosspolymer, C12-15 Alkyl Benzoate, Tocopheryl Acetate, Cola Acuminata (Kola) Seed Extract, Vitis Vinifera (Grape) Seed Extract, Carthamus Tinctorius (Safflower) Seed Oil, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Octyldodecyl Neopentanoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Acetyl Hexapeptide-8, Phenyl Trimethicone, Water\Aqua\Eau, Silica, Laureth-12, Hexyl Laurate, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Caprylyl Glycol, Hexylene Glycol, Hydrogenated Polydecene, Phenoxyethanol, Potassium Sorbate, Iron Oxides (CI 77491) <ILN39369>

Other information

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

Smashbox Cosmetics, Dist.
Culver City, CA 90232

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

smashbox

PHOTO FINISH
FOUNDATION PRIMER

SPF 20
WITH DERMAXYL™ COMPLEX

BROAD SPECTRUM SPF 20
1 fl. oz. / 30 ml e

SMASHBOX   PHOTO FINISH FOUNDATION PRIMER SPF 20
avobenzone, homosalate, and octisalate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10348-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE15 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Cyclomethicone 5 
Alkyl (C12-15) Benzoate 
.Alpha.-Tocopherol Acetate 
cola acuminata seed 
Vitis Vinifera Seed 
Safflower Oil 
Polyglyceryl-4 Isostearate 
Octyldodecyl Neopentanoate 
Tribehenin 
Ceramide 2 
PEG-10 Rapeseed Sterol 
Palmitoyl Oligopeptide 
Acetyl Hexapeptide-8 
Phenyl Trimethicone 
Water 
Silicon Dioxide 
Laureth-12 
Hexyl Laurate 
Triethoxycaprylylsilane 
Caprylyl Glycol 
Hexylene Glycol 
Phenoxyethanol 
Potassium Sorbate 
Ferric Oxide Red 
Packaging
#Item CodePackage Description
1NDC:10348-006-011 TUBE in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/27/2012
Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195RELABEL(10348-006), REPACK(10348-006)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(10348-006), RELABEL(10348-006), REPACK(10348-006)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(10348-006)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(10348-006), RELABEL(10348-006)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(10348-006)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(10348-006)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(10348-006)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(10348-006)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(10348-006)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(10348-006), RELABEL(10348-006), REPACK(10348-006)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(10348-006), RELABEL(10348-006), REPACK(10348-006)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(10348-006), RELABEL(10348-006), REPACK(10348-006)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(10348-006)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(10348-006)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(10348-006), RELABEL(10348-006)
Establishment
NameAddressID/FEIOperations
MANA Cosmetics Inc078870292MANUFACTURE(10348-006)

Revised: 07/2012
 
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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