OBAGI-C C-RX SYSTEM NORMAL-OILY SKIN INTERVENTION- hydroquinone, titanium dioxide, zinc oxide kit

Obagi-C C-Rx system Normal-oily skin Intervention by

Drug Labeling and Warnings

Obagi-C C-Rx system Normal-oily skin Intervention 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., PURETEK CORPORATION, Universal Packaging Systems, Inc. (DBA Paklab). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 6.2%	Sunscreen
Zinc Oxide 15.6%	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

aqua/water/eau, caprylic/capric triglyceride, dicaprylyl carbonate, pentylene glycol, steareth-2, glycerin, silica, polyhydroxystearic acid, steareth-21, cetearyl alcohol, propanediol, alumina, stearic acid, sodium stearoyl glutamate, caprylyl glycol, triethoxycaprylylsilane, cetearyl glucoslde, xanthan gum, dipotassium glycyrrhizate,trisodium ethylenediamine disuccinate, caprylhydroxamic acid, tropaeolum majus flower/leaf/stem extract.

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. www.obagi.com

PRINCIPAL DISPLAY PANEL - Kit Carton

OBAGI®
MEDICAL

OBAGI-C® Rx SYSTEM

Complete skin care system specifically formulated for normal to oily skin with
hydroquinone to reduce hyperpigmentation and other essential ingredients to help
address the signs of sun exposure caused by photoaging.

NORMAL OILY

Skin Intervention Kit

NDC: 62032-923-01

INGREDIENTS AND APPEARANCE

OBAGI-C C-RX SYSTEM NORMAL-OILY SKIN INTERVENTION 
hydroquinone, titanium dioxide, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-923

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-923-01	1 in 1 BAG	06/25/2025

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 RX SYSTEM C-CLARIFYING SERUM NORMAL TO OILY  SKIN LIGHTENING SERUM WITH VITAMIN C
hydroquinone liquid

Product Information
Item Code (Source)	NDC: 62032-122
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 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALCOHOL (UNII: 3K9958V90M)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-122-10	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
UNAPPROVED DRUG OTHER		01/01/2010

Part 2 of 5

OBAGI-C RX SYSTEM C-THERAPY NIGHT  SKIN LIGHTENING WITH VITAMINS C AND E
hydroquinone cream

Product Information
Item Code (Source)	NDC: 62032-105
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)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-105-36	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		01/01/2004

Part 3 of 5

SUN SHIELD MINERAL BROAD SPECTRUM SPF 50  SUNSCREEN
titanium dioxide and zinc oxide lotion

Product Information
Item Code (Source)	NDC: 62032-811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
TROPAEOLUM MAJUS FLOWERING TOP (UNII: RGT30824HY)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-811-09	1 in 1 CARTON
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 DRUG	M020	12/02/2019

Part 4 of 5

OBAGI-C C-CLEANSING  WITH VITAMIN C
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	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	MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD)
INGR	CHAMOMILE (UNII: FGL3685T2X)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)
INGR	BORAGE (UNII: PB618V0K2W)

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 C-BALANCING TONER  FOR NORMAL TO OILY SKIN
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	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		06/25/2025

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Bay Cities Container Corporation		118417470	PACK(62032-923) , LABEL(62032-923)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss American CDMO, LLC		080170933	MANUFACTURE(62032-923)

Establishment
Name	Address	ID/FEI	Business Operations
G. S. Cosmeceutical USA, Inc.		017014734	MANUFACTURE(62032-923)

Establishment
Name	Address	ID/FEI	Business Operations
PURETEK CORPORATION		785961046	MANUFACTURE(62032-923)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc. (DBA Paklab)		177711082	MANUFACTURE(62032-923)