Obagi

OBAGI — hydroquinone, octinoxate, zinc oxide
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.

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, chamomilla recutita (matricaria ) flower extract (chamomilla recutita extract ),

sodium chlordie, saponins, xanthan gum, phenoxyethanol, methylparaben, ethylparaben,

butylparaben, propylparaben, isobutylparaben, fragrance (parfum ), red 33 (CI 17200 ),

yellow 5 (CI 19140)

C BALANCING TONER 6.7 FL OZ ( 198 ML )AM + PM

Specifically formulated for normal to oily skin, the C — Balancing Toner adjusts your

skin’s pH balance. As an essential step after cleansing, this alcohol — free, non — drying

toner throughly removes impurities and dead skin cells to prepare the skin for the next step

in your sklin care regimen.

Directions

Use twice daily, in the morning and evening after cleansing. Pump a small amount ( 3 — 4 pumps )

onto a cotton pad and gently wipe over entire face. Let air dry. Do not rinse.

Warnings

Avoid getting into eyes. For external use only.

Keep out of reach of children.

Ingredients

water ( aqua ) hamamelis virginiana ( witch hazel ) water, propylene glycol, sodium pca,

benzalkonium chlordie, aloe barbadensis leaf juice (aloe barbadensis ), panthenol,

polyquaternium — 10, phenoxyethanol, methylparaben

C — CLARIFYING SERUM NORMAL TO OILY [ SKIN LIGHTENING SERUM ] 1 FL. OZ.

[30 MIL.], HYDROQUINONE USP, 4 % RX ONLY AM

Antioxidant serum containing Vitamin C and prescription — strength hydroquinone. This patented

formulation for normal to oily skin reduces the appearance of dark spots for a lighter, brighter

complexion.

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

senile lentigines, 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 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 Oily contains:

Active Ingredients:

Hydroquinone USP, 4 % (40 mg / g)

Inactive Ingredeints:

water, propylene glycol, alcohol denat., pipropylene glycol, ascorbic acid,

propylene glycol, sodium lauryl sulfate, fragrance

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY

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 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.

The gradual bleaching of hyperpigmented skin conditions such as 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 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.

Warning

Avoid contact with eyes, nose, mouth and lips. in case of accidental contact,

patient should rinse eyes thoroughly with water and contact physician. Sunscreen is

an essential aspect of hydroquinone therpay 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 myristral 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.

SUN SHIELD BROAD SPECTRUM SPF 50 MATTE NET WT. 3 OZ. [85 G ]

This sunscreen combines 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

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 or higher and other sun protection measures

including:

— limit time in the sun especially from 10 am — 2 pm

— wear long — sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

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

cyclopentasiloxane, dimethicone, dimethicone crosspolymer — 3, disodium EDTA, glycerin,

hydrogenated palm glycerides, hydroxyethyl acrylate / 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, wtaer, xanthan gum

- 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 am — 4 pm Pacific Time

copy of label
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OBAGI hydroquinone, octinoxate, zinc oxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69269-523
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69269-523-04 1 KIT (KIT) in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 57 g
Part 2 1 BOTTLE, GLASS 30 mL
Part 3 1 TUBE 85 g
Part 1 of 3
OBAGI — C hydroquinone liquid
Product Information
Item Code (Source) NDC:69269-105
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CETYL ALCOHOL
PPG-2 MYRISTYL ETHER PROPIONATE
SODIUM LAURYL SULFATE
TROLAMINE SALICYLATE
LACTIC ACID
PHENYL TRIMETHICONE
.ALPHA.-TOCOPHEROL ACETATE
SODIUM DITHIONATE
ASCORBIC ACID
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69269-105-36 57 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2014
Part 2 of 3
OBAGI — C hydroquinone liquid
Product Information
Item Code (Source) NDC:69269-122
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
WATER
ASCORBIC ACID
PROPYLENE CARBONATE
SODIUM LAURYL SULFATE
ALCOHOL
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69269-122-10 1 BOTTLE, GLASS (BOTTLE) in 1 CARTON contains a BOTTLE, GLASS
1 30 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (69269-122-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2014
Part 3 of 3
OBAGI octinoxate, zinc oxide cream
Product Information
Item Code (Source) NDC:69269-121
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 105 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5
WATER
PEG-10 DIMETHICONE (600 CST)
PENTYLENE GLYCOL
STEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
PHENYL TRIMETHICONE
PEG-40 STEARATE
SODIUM DIHYDROXYCETYL PHOSPHATE
HYDROGENATED PALM GLYCERIDES
CITRIC ACID MONOHYDRATE
CETOSTEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
TROPOLONE
CHLORPHENESIN
XANTHAN GUM
POTASSIUM SORBATE
SODIUM BENZOATE
TETRAHEXYLDECYL ASCORBATE
UBIDECARENONE
EDETATE DISODIUM
METHYLISOTHIAZOLINONE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
SQUALANE
POLYSORBATE 60
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69269-121-90 85 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2014
Labeler — YS PLUS CORPORATION (843007597)
Establishment
Name Address ID/FEI Operations
YS PLUS CORPORATION 843007597 repack (69269-523)

Revised: 10/2014 YS PLUS CORPORATION

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