OBAGI- hydroquinone 
YS PLUS CORPORATION

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.

----------

Drug Facts

WELCOME TO THE OBAGI - C RX SYSTEM OF SKIN CARE PRODUCTS

See enclosed packet for full prescribing information

For external use only

Rx only

C-Clarifying Serum Normal to Dry (Skin Lightening Serum)  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.

The gradual bleach hyperpigmented skin conditions such as chloasma, melasma,

freckles, lengitines, and other unwanted areas of melanin hyperpigmentation.

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 treatrment,  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 maintains melanocytic activity.

Active Ingredient

Hydroquinonone USP, 4 % (40 mg /g )

Inactive ingredients

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

C - Therapy Night Cream (Skin Lightener) 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 us 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.

The gradual bleaching of hyperpigmented skin conditions such a chloasma, melasma, freckles, senile

lentigines, and other unwanted areas of melanin hyperpigmentation.

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, 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 metabisulfate, a sulfate that may cause allergic - type reactions including

anaphylactic symptoms and life - threatening or less severe asthmatic episodes in certain

susceptible people. The overall presence 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 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 Broad Spectrum SPF 50 Matte Net wt. 3 oz. ( 85 g )

This sunscreen contains UVB absorption and UVA protection in an elegant matte finish that is

non - comedogenic, hypoallergenic, non - acnegenic, and dermatologist tested. Sheer, PABA free,

and fragrance free for all skin types.

Active Ingredients

Octinoxate 7.5 %

Zinc Oxide 10.5 %

Purpose

Sunscreen

Inactive Ingredients

1,2 - hexanediol, caprylyl glycol, ceteareth - 20, cetearyl alcohol, chlorphenesin, citric acid,

cyclopentasilozane, dimethicone, dimethicone crosspolymer - 3, disodium EDTA, glycerin,

hydrogenated palm glycerides, hydroxyethyl arylate / sodium acryloyldimethyl taurate copolymer,

methylisothiazolinone, PEG - 40 stearate, pentylene glycol, phenoxyehtanol, phenyl trimethicone,

polysilicone - 11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl

phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate,

tropolone, water, xanthan gum

Store at controlled room temperature: 15 C - 25 C (59 F - 77 F)

protect t product from excessive heat and direct sun

Questions or comments?

1.800.636.7546

Monday - Friday 9 am - 4 pm Pacific Time

copy of label
OBAGI 
hydroquinone kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69269-524
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69269-524-041 in 1 KIT; Type 0: Not a Combination Product10/01/201412/31/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 57 g
Part 21 BOTTLE, GLASS 30 mL
Part 31 TUBE 85 g
Part 1 of 3
OBAGI - C 
hydroquinone liquid
Product Information
Item Code (Source)NDC:69269-105
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM DITHIONATE (UNII: RPF7Z41GAW)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69269-105-3657 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/01/201412/31/2015
Part 2 of 3
OBAGI - C 
hydroquinone liquid
Product Information
Item Code (Source)NDC:69269-106
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)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69269-106-1030 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/01/201412/31/2015
Part 3 of 3
OBAGI 
octinoxate, zinc oxide cream
Product Information
Item Code (Source)NDC:69269-121
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 (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69269-121-9085 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/201412/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/01/201412/31/2015
Labeler - YS PLUS CORPORATION (843007597)

Revised: 6/2017
 
YS PLUS CORPORATION