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
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Drug Label Information
Updated October 29, 2019
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- 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)