OBAGI-C RX SYSTEM NORMAL-DRY  SKIN INTERVENTION- hydroquinone, octinoxate and zinc oxide 
OMP, INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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OBAGI-C® RX SYSTEM NORMAL-DRY
SKIN INTERVENTION KIT

C-Cleansing Gel 6 fl. oz. (177 mL.) AM+PM

A gel-based facial cleanser that clarifies and prepares your skin for absorption of the system's product ingredients. This concentrated cleanser gently removes excess oil, makeup, and other everyday impurities, and rinses clean, leaving your skin feeling fresh and clear.

Directions

Use twice daily, morning and evening. Massage a small amount of cleanser and lukewarm water onto skin, rubbing gently in a circular motion. Rinse completely with lukewarm water and gently pat dry.

Warnings

Avoid getting into eyes. For external use only.

Keep out of reach of children.

Ingredients

water (aqua), sodium laureth sulfate, sodium lauroyl oat amino acids, cocamidopropyl betaine, aloe barbadensis leaf juice (aloe barbadensis), ascorbic acid, glycerin, medicago sativa (alfalfa) extract, borago officinalis extract, chamomilla recutita (matricaria) flower extract (chamomilla recutita extract), sodium chloride, saponins, xanthan gum, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), red 33 (CI 17200), yellow 5 (CI 19140)

C-Clarifying Serum Normal to Dry (Skin Lightening Serum) NDC 62032-106-10 1 fl. oz. (30 mL.) Hydroquinone USP, 4% Rx Only AM

Antioxidant serum containing Vitamin C and prescription-strength hydroquinone. This patented formulation for normal to dry skin reduces the appearance of dark spots for a lighter, brighter complexion.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and administration

Use once daily in the morning. Apply 5-7 drops to the entire face, or as directed by your skin care physician. Massage in gently. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Warnings

Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Each gram of Obagi-C Rx C-Clarifying Serum Normal to Dry contains:

Active Ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive Ingredients

propylene glycol, water, ascorbic acid, propylene carbonate, sodium lauryl sulfate.

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

C-Exfoliating Day Lotion Net wt. 2 oz. (57 g.) AM

A smooth, lightweight moisturizer that not only hydrates, but also gently exfoliates the skin, revealing a brighter, healthier-looking complexion.

Directions

Use once daily in the morning. Squeeze a small amount (approximately 1-2 pea-sized drops) onto your hands. Using your fingertips, apply evenly to the entire face. Massage gently until completely absorbed.

Warnings

Avoid getting into eyes. For external use only.

Keep out of reach of children.

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Ingredients

water (aqua), ethylhexyl palmitate, ethylhexyl stearate, glycolic acid, caprylic/capric triglyceride, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isopropyl palmitate, sodium hyaluronate, squalane, PEG-8 dimethicone, glyceryl stearate, PEG-100 stearate, glycerin, sodium hydroxide, PEG-8 ricinoleate, ascorbyl glucoside, tocopheryl acetate, dimethicone, arginine, cetearyl alcohol, ceteareth-20, steareth-2, bisabolol, tetrasodium EDTA, polysorbate 60, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum)

C-Therapy Night Cream (Skin Lightener) NDC 62032-105-36 Net wt. 2 oz. (57 g.) Hydroquinone USP, 4% Rx Only PM

A rich moisturizer that works while you sleep to renew and rejuvenate your skin. The C-Therapy Night Cream is uniquely formulated with prescription-strength hydroquinone to gradually diminish the appearance of dark spots and delivers Vitamins C and E during the skin's nightly renewal process.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and administration

Use daily in the evening. Dispense a small amount (approximately 1-2 pea-sized drops) and apply to the entire face. Massage in gently. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.

Warnings

Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Each gram of Obagi-C Rx C-Therapy Night Cream contains:

Active Ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive Ingredients

water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Travel Bag and Patient Instruction Guide

Sun Shield Matte Broad Spectrum SPF 50 Net wt. 3 oz. (85 g.)

This sunscreen combines UVB absorption and UVA protection in an elegant, matte finish that is non-comedogenic, allergy tested, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.

Drug Facts

Active ingredientsPurpose
Octinoxate 7.5%Sunscreen
Zinc Oxide 10.5%Sunscreen

Uses

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

Inactive ingredients

1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum

Other information

Questions or comments?

1.800.636.7546
Monday–Friday 9 a.m.-4 p.m. Pacific Time

Store at controlled room temperature 15°C–25°C (59°F–77°F).

Obagi, Obagi-C and the Obagi logo are registered trademarks
of OMP, Inc.

©2012 Obagi Medical Products, Inc. All Rights Reserved.
OBAGI.COM Made in USA 41502210Z 5022

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC# 62032-518-04

OBAGI®
MEDICAL

OBAGI-C® RX SYSTEM

NORMAL DRY
Skin Intervention Kit

PRINCIPAL DISPLAY PANEL - Kit Carton
OBAGI-C RX SYSTEM NORMAL-DRY  SKIN INTERVENTION
hydroquinone, octinoxate and zinc oxide kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62032-518
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-518-041 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, GLASS 30 mL
Part 21 BOTTLE, PLASTIC 57 g
Part 31 TUBE 85 g
Part 41 BOTTLE, PLASTIC 177 mL
Part 51 BOTTLE, PLASTIC 57 g
Part 1 of 5
OBAGI-C RX SYSTEM C-CLARIFYING SERUM   SKIN LIGHTENING SERUM WITH VITAMIN C
hydroquinone liquid
Product Information
Item Code (Source)NDC:62032-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-106-101 in 1 CARTON
130 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/2004
Part 2 of 5
OBAGI-C RX SYSTEM C-THERAPY   SKIN LIGHTENING WITH VITAMINS C AND E
hydroquinone cream
Product Information
Item Code (Source)NDC:62032-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 (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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-105-3657 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/2004
Part 3 of 5
OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50  MATTE SUNSCREEN
octinoxate and zinc oxide lotion
Product Information
Item Code (Source)NDC:62032-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE105 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TROPOLONE (UNII: 7L6DL16P1T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
UBIDECARENONE (UNII: EJ27X76M46)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-121-9085 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/07/2012
Part 4 of 5
OBAGI-C RX SYSTEM C-CLEANSING  WITH VITAMIN C
cleansing (cold creams, cleansing lotions, liquids, and pads) gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRALFALFA (UNII: DJO934BRBD)  
INGRCHAMOMILE (UNII: FGL3685T2X)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/2004
Part 5 of 5
OBAGI-C RX SYSTEM C-EXFOLIATING DAY  WITH VITAMIN C
face and neck (excluding shaving preparations) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
INGRPEG-8 DIMETHICONE (UNII: GIA7T764OD)  
INGRPEG-8 RICINOLEATE (UNII: DM36F4D2OU)  
INGRGLYCOLIC ACID (UNII: 0WT12SX38S)  
INGRARGININE (UNII: 94ZLA3W45F)  
INGRETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRSTEARETH-2 (UNII: V56DFE46J5)  
INGRASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGREDETATE SODIUM (UNII: MP1J8420LU)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
157 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/07/2012
Labeler - OMP, INC. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
PURETEK CORPORATION785961046MANUFACTURE(62032-518) , LABEL(62032-518) , PACK(62032-518)
Establishment
NameAddressID/FEIBusiness Operations
Ei INC.105803274MANUFACTURE(62032-518) , LABEL(62032-518) , PACK(62032-518) , ANALYSIS(62032-518)
Establishment
NameAddressID/FEIBusiness Operations
MILBAR LABORATORIES195556790MANUFACTURE(62032-518)
Establishment
NameAddressID/FEIBusiness Operations
Bay Cities Container Corporation066229618RELABEL(62032-518) , REPACK(62032-518)

Revised: 1/2013
Document Id: aba5eec8-1945-4753-b301-bc612936cec1
Set id: 892bbe2c-cc50-4aea-99f1-0bcd1151f266
Version: 1
Effective Time: 20130102
 
OMP, INC.