Label: OBAGI-C FX SYSTEM NORMAL-OILY SKIN BRIGHTENING SYSTEM WITH ARBUTIN- homosalate, octisalate, and zinc oxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 62032-142-11, 62032-536-57 - Packager: Obagi Cosmeceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 29, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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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 SPF 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: Ask a doctor
- Other information
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Inactive ingredients
Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
OBAGI-C FX SYSTEM NORMAL-OILY SKIN BRIGHTENING SYSTEM WITH ARBUTIN
homosalate, octisalate, and zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-536 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-536-57 1 in 1 CARTON 12/02/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, GLASS 30 mL Part 2 1 BOTTLE, PLASTIC 57 g Part 3 1 TUBE 85 g Part 4 1 BOTTLE, PLASTIC 177 mL Part 5 1 BOTTLE, PLASTIC 198 mL Part 1 of 5 OBAGI -C FX SYSTEM C-CLARIFYING SERUM SKIN BRIGHTENING SERUM
lotions, oils, powders, and creams liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR WATER (UNII: 059QF0KO0R) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR SODIUM LAURYL SULFATE (UNII: 368GB5141J) INGR PROPYLENE CARBONATE (UNII: 8D08K3S51E) INGR ALCOHOL (UNII: 3K9958V90M) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR ARBUTIN (UNII: C5INA23HXF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/01/2010 Part 2 of 5 OBAGI -C FX SYSTEM C-THERAPY NIGHT SKIN BRIGHTENER
night creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) INGR TROLAMINE SALICYLATE (UNII: H8O4040BHD) INGR SODIUM LAURYL SULFATE (UNII: 368GB5141J) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR WATER (UNII: 059QF0KO0R) INGR ARBUTIN (UNII: C5INA23HXF) Product Characteristics color WHITE C48325 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/01/2004 Part 3 of 5 OBAGI -C FX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
homosalate, octisalate, and zinc oxide lotionProduct Information Item Code (Source) NDC:62032-142 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 165 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Hydroxyacetophenone (UNII: G1L3HT4CMH) XANTHAN GUM (UNII: TTV12P4NEE) Sodium Chloride (UNII: 451W47IQ8X) Sodium Hydroxide (UNII: 55X04QC32I) Octyldodecyl Neopentanoate (UNII: X8725R883T) Triethoxycaprylylsilane (UNII: LDC331P08E) C15-19 Alkane (UNII: CI87N1IM01) Disteardimonium Hectorite (UNII: X687XDK09L) POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC) Sorbitan Olivate (UNII: MDL271E3GR) DIMETHICONE (UNII: 92RU3N3Y1O) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) Candelilla Wax (UNII: WL0328HX19) Yellow Wax (UNII: 2ZA36H0S2V) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) Silicon Dioxide (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-142-11 85 g 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 FINAL part352 12/02/2019 Part 4 of 5 OBAGI -C FX SYSTEM C-CLEANSING
cleansing (cold creams, cleansing lotions, liquids, and pads) gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR ALFALFA (UNII: DJO934BRBD) INGR CHAMOMILE (UNII: FGL3685T2X) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L) INGR BORAGE (UNII: PB618V0K2W) Product Characteristics color ORANGE C48331 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/01/2004 Part 5 of 5 OBAGI -C FX SYSTEM C-BALANCING TONER
cleansing (cold creams, cleansing lotions, liquids, and pads) liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) INGR BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR POLYQUATERNIUM-10 (400 MPA.S At 2%) (UNII: HB1401PQFS) INGR PANTHENOL (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date COSMETIC 01/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/02/2019 Labeler - Obagi Cosmeceuticals LLC (790553353) Establishment Name Address ID/FEI Business Operations Universal Packaging Systems, Inc. DBA: PakLab 790530976 MANUFACTURE(62032-536) , LABEL(62032-536) , PACK(62032-536) Establishment Name Address ID/FEI Business Operations Swiss American CDMO, LLC 080170933 MANUFACTURE(62032-536) Establishment Name Address ID/FEI Business Operations Bay Cities Container Corporation 066229618 RELABEL(62032-536) , REPACK(62032-536)
