OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION- hydroquinone, octinoxate and zinc oxide kit

OBAGI-C RX SYSTEM NORMAL-DRY by

Drug Labeling and Warnings

OBAGI-C RX SYSTEM NORMAL-DRY by is a Prescription medication manufactured, distributed, or labeled by OMP, INC., PURETEK CORPORATION, Ei INC., MILBAR LABORATORIES, Bay Cities Container Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

SPL UNCLASSIFIED SECTION

Travel Bag and Patient Instruction Guide

SPL UNCLASSIFIED SECTION

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 INGREDIENT

Active ingredients	Purpose
Octinoxate 7.5%	Sunscreen
Zinc Oxide 10.5%	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
• children under 6 months: Ask a doctor
• 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 of 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

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

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

Questions or comments?

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

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

OBAGI-C RX SYSTEM NORMAL-DRY  SKIN INTERVENTION
hydroquinone, octinoxate and zinc oxide kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62032-518

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-518-04	1 in 1 CARTON

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	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 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-106-10	1 in 1 CARTON
1		30 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/2004

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 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 (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	NDC: 62032-105-36	57 g in 1 BOTTLE, PLASTIC

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

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	105 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-121-90	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/07/2012

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 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	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	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		177 mL in 1 BOTTLE, PLASTIC

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 RX SYSTEM C-EXFOLIATING DAY  WITH VITAMIN C
face and neck (excluding shaving preparations) lotion

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	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
INGR	PEG-8 DIMETHICONE (UNII: GIA7T764OD)
INGR	PEG-8 RICINOLEATE (UNII: DM36F4D2OU)
INGR	GLYCOLIC ACID (UNII: 0WT12SX38S)
INGR	ARGININE (UNII: 94ZLA3W45F)
INGR	ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	STEARETH-2 (UNII: V56DFE46J5)
INGR	ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		57 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		11/07/2012

Labeler - OMP, INC. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
PURETEK CORPORATION		785961046	MANUFACTURE(62032-518) , LABEL(62032-518) , PACK(62032-518)

Establishment
Name	Address	ID/FEI	Business Operations
Ei INC.		105803274	MANUFACTURE(62032-518) , LABEL(62032-518) , PACK(62032-518) , ANALYSIS(62032-518)

Establishment
Name	Address	ID/FEI	Business Operations
MILBAR LABORATORIES		195556790	MANUFACTURE(62032-518)

Establishment
Name	Address	ID/FEI	Business Operations
Bay Cities Container Corporation		066229618	RELABEL(62032-518) , REPACK(62032-518)