OBAGI NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION TRIAL- hydroquinone, homosalate, octisalate, zinc oxide kit

Obagi Nu-Derm System Normal-Oily Skin Transformation Trial by

Drug Labeling and Warnings

Obagi Nu-Derm System Normal-Oily Skin Transformation Trial by is a Prescription medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, G. S. Cosmeceutical USA, Inc., 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 Polyricinoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (Candelilla) Wax, Beeswax (Cera Alba), Dimethicone

Questions or comments?

1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. PST

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - Kit Carton

OBAGI®
MEDICAL

OBAGI NU-DERM® SYSTEM

A total systematic approach to skin care. Addresses signs of skin
aging, gently exfoliates to promote cell turnover and suppresses
melanocyte activity to reduce hyperpigmentaion.

NORMAL OILY

Skin Transformation Trial Kit

INGREDIENTS AND APPEARANCE

OBAGI NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION TRIAL 
hydroquinone, homosalate, octisalate, zinc oxide kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62032-914

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-914-01	1 in 1 KIT	06/25/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	59 mL
Part 2	1 BOTTLE, PLASTIC	59 mL
Part 3	1 BOTTLE, PLASTIC	57 g
Part 4	1 BOTTLE, PLASTIC	28 g
Part 5	1 BOTTLE, PLASTIC	28 g
Part 6	1 TUBE	28 g

Part 1 of 6

NU-DERM FOAMING 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] gel

Product 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	MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)
INGR	BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 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 6

NU-DERM TONER 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 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 6

NU-DERM CLEAR  SKIN BLEACHING AND CORRECTOR
hydroquinone cream

Product Information
Item Code (Source)	NDC: 62032-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-101-36	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
unapproved drug other		01/01/1988

Part 4 of 6

NU-DERM EXFODERM FORTE  EXFOLIATION ENHANCER
face and neck (excluding shaving preparations), leave-on [skin care preparations (creams, lotions, powder, and sprays)] lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	DIMETHICONE, UNSPECIFIED (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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 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 6

NU-DERM BLENDER  SKIN LIGHTENER AND BLENDING
hydroquinone cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
TROLAMINE SALICYLATE (UNII: H8O4040BHD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 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
unapproved drug other		01/01/1988

Part 6 of 6

SUN SHIELD BROAD SPECTRUM SPF 50 MATTE  SUNSCREEN
homosalate, octisalate, and zinc oxide lotion

Product Information
Item Code (Source)	NDC: 62032-140
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, UNSPECIFIED (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: 62032-140-05	28 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 DRUG	M020	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)

Registrant - G. S. Cosmeceutical USA, Inc. (017014734)

Establishment
Name	Address	ID/FEI	Business Operations
G. S. Cosmeceutical USA, Inc.		017014734	MANUFACTURE(62032-914)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss American CDMO, LLC		080170933	MANUFACTURE(62032-914)

Establishment
Name	Address	ID/FEI	Business Operations
Bay Cities Container Corporation		118417470	PACK(62032-914) , LABEL(62032-914)