OBAGI-C FX SYSTEM NORMAL-OILY SKIN BRIGHTENING SYSTEM WITH ARBUTIN- homosalate, octisalate, and zinc oxide kit

Obagi-C Fx System Normal-Oily by

Drug Labeling and Warnings

Obagi-C Fx System Normal-Oily by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, Universal Packaging Systems, Inc. DBA: PakLab, Swiss American CDMO, LLC, Bay Cities Container Corporation. 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-C® FX SYSTEM

NORMAL OILY

Skin Brightening System
with Arbutin

INGREDIENTS AND APPEARANCE

OBAGI-C FX SYSTEM NORMAL-OILY   SKIN BRIGHTENING SYSTEM WITH ARBUTIN
homosalate, octisalate, and zinc oxide kit

Product 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 liquid

Product 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 cream

Product 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 lotion

Product 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) gel

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	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) liquid

Product 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)