Label: OBAGI NU-DERM FX SYSTEM NORMAL - OILY SKIN TRANSFORMATION COMPLEXION BRIGHTENING SYSTEM- homosalate, octisalate, and zinc oxide kit
- NDC Code(s): 62032-538-91
- Packager: Obagi Cosmeceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 25, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
INGREDIENTS AND APPEARANCE
OBAGI NU-DERM FX SYSTEM NORMAL - OILY SKIN TRANSFORMATION COMPLEXION BRIGHTENING SYSTEM
homosalate, octisalate, and zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-538 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-538-91 1 in 1 CARTON 12/02/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 198 mL Part 2 1 BOTTLE, PLASTIC 198 mL Part 3 1 BOTTLE, PLASTIC 57 g Part 4 1 BOTTLE, PLASTIC 57 g Part 5 1 BOTTLE, PLASTIC 48 g Part 6 1 BOTTLE, PLASTIC 57 g Part 7 1 TUBE 85 g Part 1 of 7 NU-DERM FOAMING
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 PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR ETHYLPARABEN (UNII: 14255EXE39) INGR ISOBUTYLPARABEN (UNII: 0QQJ25X58G) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 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) Product Characteristics color RED C48326 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 01/01/1988 Part 2 of 7 NU-DERM TONER
face and neck (excluding shaving preparations) liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR DMDM HYDANTOIN (UNII: BYR0546TOW) INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) INGR POTASSIUM ALUM (UNII: 1L24V9R23S) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR SAGE (UNII: 065C5D077J) INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) INGR POLYSORBATE 80 (UNII: 6OZP39ZG8H) INGR ALLANTOIN (UNII: 344S277G0Z) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics color BLUE C48333 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 01/01/1988 Part 3 of 7 NU-DERM CLEAR FX SKIN BRIGHTENING
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 ARBUTIN (UNII: C5INA23HXF) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM LAURYL SULFATE (UNII: 368GB5141J) INGR STEARYL ALCOHOL (UNII: 2KR89I4H1Y) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR BUTYLPARABEN (UNII: 3QPI1U3FV8) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) 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 01/01/1988 Part 4 of 7 NU-DERM EXFODERM FORTE EXFOLIATION ENHANCER
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR EMU OIL (UNII: 344821WD61) INGR STEARIC ACID (UNII: 4ELV7Z65AP) INGR STEARYL ALCOHOL (UNII: 2KR89I4H1Y) INGR GLYCOLIC ACID (UNII: 0WT12SX38S) 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 01/01/1988 Part 5 of 7 NU-DERM HYDRATE FACIAL MOISTURIZER
moisturizing lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR SACCHARIDE ISOMERATE (UNII: W8K377W98I) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR LAURETH-12 (UNII: OAH19558U1) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR STEARIC ACID (UNII: 4ELV7Z65AP) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR SOY STEROL (UNII: PL360EPO9J) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR LEVOMENOL (UNII: 24WE03BX2T) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) INGR SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) INGR CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) INGR ALLANTOIN (UNII: 344S277G0Z) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Product Characteristics color WHITE C48325 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 48 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 11/07/2012 Part 6 of 7 NU-DERM BLEND FX SKIN BRIGHTENER AND BLENDING
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR ARBUTIN (UNII: C5INA23HXF) INGR PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) INGR SODIUM LAURYL SULFATE (UNII: 368GB5141J) INGR TROLAMINE SALICYLATE (UNII: H8O4040BHD) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) INGR PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) 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 01/01/1988 Part 7 of 7 NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
homosalate, octisalate, and zinc oxide lotionProduct Information 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 ISOSTEARATE (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 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 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 Swiss-American CDMO, LLC 080170933 MANUFACTURE(62032-538) Establishment Name Address ID/FEI Business Operations G. S. Cosmeceutical USA, Inc. 017014734 MANUFACTURE(62032-538)
