Label: SMASHBOX PHOTO FINISH FOUNDATION PRIMER SPF 20- avobenzone, homosalate, and octisalate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 10348-006-01 - Packager: SMASHBOX BEAUTY COSMETICS, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 31, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
- Warnings
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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
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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
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
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INGREDIENTS AND APPEARANCE
SMASHBOX PHOTO FINISH FOUNDATION PRIMER SPF 20
avobenzone, homosalate, and octisalate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10348-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 mL in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL Inactive Ingredients Ingredient Name Strength Cyclomethicone 5 (UNII: 0THT5PCI0R) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) cola acuminata seed (UNII: 1F8VIW1479) Vitis Vinifera Seed (UNII: C34U15ICXA) Safflower Oil (UNII: 65UEH262IS) Polyglyceryl-4 Isostearate (UNII: 820DPX33S7) Octyldodecyl Neopentanoate (UNII: X8725R883T) Tribehenin (UNII: 8OC9U7TQZ0) Ceramide 2 (UNII: C04977SRJ5) PEG-10 Rapeseed Sterol (UNII: 258O76T85M) Palmitoyl Oligopeptide (UNII: HO4ZT5S86C) Acetyl Hexapeptide-8 (UNII: L4EL31FWIL) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Water (UNII: 059QF0KO0R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Laureth-12 (UNII: OAH19558U1) Hexyl Laurate (UNII: 4CG9F9W01Q) Triethoxycaprylylsilane (UNII: LDC331P08E) Caprylyl Glycol (UNII: 00YIU5438U) Hexylene Glycol (UNII: KEH0A3F75J) Phenoxyethanol (UNII: HIE492ZZ3T) Potassium Sorbate (UNII: 1VPU26JZZ4) Ferric Oxide Red (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10348-006-01 1 in 1 CARTON 1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/27/2012 Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(10348-006) , REPACK(10348-006) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(10348-006) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(10348-006) , RELABEL(10348-006) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(10348-006) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(10348-006) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(10348-006) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(10348-006) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(10348-006) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(10348-006) , RELABEL(10348-006) , REPACK(10348-006) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(10348-006) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(10348-006) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(10348-006) , RELABEL(10348-006) Establishment Name Address ID/FEI Business Operations MANA Cosmetics Inc 078870292 MANUFACTURE(10348-006)