OBAGI NU-DERM FX SYSTEM NORMAL - DRY SKIN TRANSFORMATION COMPLEXION BRIGHTENING SYSTEM- homosalate, octisalate, and zinc oxide kit

Obagi Nu-Derm FX System Normal - Dry by

Drug Labeling and Warnings

Obagi Nu-Derm FX System Normal - Dry by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, Bay Cities Container Corporation, Swiss-American CDMO, LLC, G. S. Cosmeceutical USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Homosalate 10%	Sunscreen
Octisalate 5%	Sunscreen
Zinc Oxide 16.5%	Sunscreen

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

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• 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

• store at controlled room temperature: 15°C–25°C (59°F–77°F)
• protect this product from excessive heat and direct sun

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?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

OBAGI®
MEDICAL

OBAGI NU-DERM FX™
SYSTEM

NORMAL DRY

Skin Transformation Kit
Complexion Brightening System

INGREDIENTS AND APPEARANCE

OBAGI NU-DERM FX SYSTEM NORMAL - DRY   SKIN TRANSFORMATION COMPLEXION BRIGHTENING SYSTEM
homosalate, octisalate, and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-539

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-539-07	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 GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product 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	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
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	GLYCERETH-7 (UNII: 3D2Y91QZ2H)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	SAGE (UNII: 065C5D077J)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	APRICOT KERNEL OIL (UNII: 54JB35T06A)
INGR	OLEYL LACTATE (UNII: B3AWW0N3GM)
INGR	BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)

Product Characteristics
color	Yellow	C48330

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 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product 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)
INGR	BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)

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) liquid

Product 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   SKIN SMOOTHING
face and neck (excluding shaving preparations) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	CANOLA OIL (UNII: 331KBJ17RK)
INGR	ISOHEXADECANE (UNII: 918X1OUF1E)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	FYTIC ACID (UNII: 7IGF0S7R8I)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	PEG-150 STEARATE (UNII: 7BSG7DF10Q)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	GLYCERETH-7 (UNII: 3D2Y91QZ2H)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
color	BLUE	C48333

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 lotion

Product 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) lotion

Product 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 lotion

Product 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
Bay Cities Container Corporation		066229618	RELABEL(62032-539) , REPACK(62032-539)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(62032-539)

Establishment
Name	Address	ID/FEI	Business Operations
G. S. Cosmeceutical USA, Inc.		017014734	MANUFACTURE(62032-539)