OBAGI-C RX System NORMAL-oily SKIN INTERVENTION (Page 2 of 2)

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

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

Questions or comments?

1.800.636.7546

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

Distributed by Obagi Cosmeceuticals LLC,
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC# 62032-534-04

OBAGI®
MEDICAL

OBAGI-C® RX SYSTEM

NORMAL
OILY

Skin Intervention Kit

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
OBAGI-C RX system C-CLEANSING WITH VITAMIN C CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OBAGI-C RX system C-BALANCING TONER FOR NORMAL TO oily SKIN CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION
hydroquinone, homosalate, octisalate and zinc oxide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62032-534
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-534-04 1 KIT in 1 KIT None
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
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
SODIUM LAURYL SULFATE
PROPYLENE CARBONATE
ALCOHOL
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 30 mL in 1 BOTTLE, GLASS None
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
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
EDETATE DISODIUM
PPG-2 MYRISTYL ETHER PROPIONATE
TROLAMINE SALICYLATE
SODIUM LAURYL SULFATE
CETYL ALCOHOL
LACTIC ACID, UNSPECIFIED FORM
.ALPHA.-TOCOPHEROL ACETATE
ASCORBIC ACID
SODIUM METABISULFITE
METHYLPARABEN
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
PHENYL TRIMETHICONE
GLYCERIN
WATER
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 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 01/01/2004
Part 3 of 5
OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
homosalate, octisalate, and zinc oxide lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 165 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
Hydroxyacetophenone
XANTHAN GUM
Sodium Chloride
Sodium Hydroxide
Octyldodecyl Neopentanoate
Triethoxycaprylylsilane
C15-19 Alkane
Disteardimonium Hectorite
Sorbitan Olivate
DIMETHICONE
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
EDETATE DISODIUM
Candelilla Wax
Yellow Wax
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
Silicon Dioxide
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 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 12/02/2019
Part 4 of 5
OBAGI-C RX SYSTEM C-CLEANSING WITH VITAMIN C
gel
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
PHENOXYETHANOL
ETHYLPARABEN
ISOBUTYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
METHYLPARABEN
FD&C YELLOW NO. 5
ASCORBIC ACID
SODIUM LAUROYL OAT AMINO ACIDS
COCAMIDOPROPYL BETAINE
SODIUM LAURETH-3 SULFATE
ALOE VERA LEAF
SODIUM CHLORIDE
MEDICAGO SATIVA WHOLE
CHAMOMILE
XANTHAN GUM
D&C RED NO. 33
BORAGE
Product Characteristics
color ORANGE C48331
Packaging
# Item Code Package Description Multilevel Packaging
1 177 mL in 1 BOTTLE, PLASTIC None
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-BALANCING TONER FOR NORMAL TO OILY SKIN
liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
METHYLPARABEN
PHENOXYETHANOL
PROPYLENE GLYCOL
ALOE VERA LEAF
HAMAMELIS VIRGINIANA TOP WATER
BENZALKONIUM CHLORIDE
SODIUM PYRROLIDONE CARBOXYLATE
POLYQUATERNIUM-10 (400 MPA.S At 2%)
PANTHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 198 mL in 1 BOTTLE, PLASTIC None
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 12/02/2019
Labeler — Obagi Cosmeceuticals LLC (790553353)
Establishment
Name Address ID/FEI Operations
G. S. Cosmeceutical USA, Inc. 017014734 MANUFACTURE (62032-534)
Establishment
Name Address ID/FEI Operations
Swiss American CDMO, LLC 080170933 MANUFACTURE (62032-534)
Establishment
Name Address ID/FEI Operations
Universal Packaging Systems, Inc. (DBA Paklab) 177711082 MANUFACTURE (62032-534), PACK (62032-534)
Establishment
Name Address ID/FEI Operations
PURETEK CORPORATION 785961046 MANUFACTURE (62032-534), LABEL (62032-534), PACK (62032-534)

Revised: 01/2023 Obagi Cosmeceuticals LLC

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