OTC Medication Information: Obagi-C Fx System Normal-Dry Skin Brightening System With Arbutin

OBAGI-C FX SYSTEM NORMAL-DRY SKIN BRIGHTENING SYSTEM WITH ARBUTIN- homosalate, octisalate, and zinc oxide
Obagi Cosmeceuticals LLC

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

Active ingredients Purpose
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Zinc Oxide 16.5% 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
  • 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

OBAGI®
MEDICAL

OBAGI-C® FX SYSTEM

NORMAL DRY

Skin Brightening System
with Arbutin

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
OBAGI -C Fx SYSTEM C-CLARIFYING SERUM SKIN BRIGHTENING SERUM LOTIONS, OILS, POWDERS, AND CREAMS
OBAGI -C Fx SYSTEM C-THERAPY NIGHTSKIN BRIGHTENER NIGHT
OBAGI -C Fx SYSTEM C-CLEANSING CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OBAGI -C Fx SYSTEM C-EXFOLIATING DAY MOISTURIZING
OBAGI-C FX SYSTEM NORMAL-DRY SKIN BRIGHTENING SYSTEM WITH ARBUTIN
homosalate, octisalate, and zinc oxide kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-537
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-537-58 1 KIT in 1 CARTON 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 57 mL
Part 1 of 5
OBAGI -C FX SYSTEM C-CLARIFYING SERUM SKIN BRIGHTENING SERUM
liquid
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
PROPYLENE GLYCOL
WATER
ASCORBIC ACID
SODIUM LAURYL SULFATE
PROPYLENE CARBONATE
ALCOHOL
ARBUTIN
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 30 mL in 1 BOTTLE, GLASS This package is contained within the CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
COSMETIC 01/01/2004
Part 2 of 5
OBAGI -C FX SYSTEM C-THERAPY NIGHT SKIN BRIGHTENER
cream
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
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
ARBUTIN
Product Characteristics
color WHITE C48325
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
COSMETIC 01/01/2004
Part 3 of 5
OBAGI C- FX 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
Polyglyceryl-2 Isostearate
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 FX SYSTEM C-CLEANSING
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
ALFALFA
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 FX SYSTEM C-EXFOLIATING DAY
lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
PHENOXYETHANOL
ETHYLPARABEN
ISOBUTYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
METHYLPARABEN
POLYSORBATE 60
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
ETHYLHEXYL PALMITATE
SQUALANE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
PEG-8 DIMETHICONE
PEG-8 RICINOLEATE
GLYCOLIC ACID
ARGININE
ETHYLHEXYL STEARATE
MEDIUM-CHAIN TRIGLYCERIDES
ISOPROPYL PALMITATE
HYALURONATE SODIUM
SODIUM HYDROXIDE
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
DIMETHICONE
STEARETH-2
ASCORBYL GLUCOSIDE
LEVOMENOL
EDETATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
Product Characteristics
color WHITE C48325
Packaging
# Item Code Package Description Multilevel Packaging
1 57 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
COSMETIC 01/02/2004
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
Universal Packaging Systems, Inc. DBA: PakLab 790530976 MANUFACTURE (62032-537), LABEL (62032-537), PACK (62032-537)
Establishment
Name Address ID/FEI Operations
Swiss American CDMO, LLC 080170933 MANUFACTURE (62032-537)
Establishment
Name Address ID/FEI Operations
Bay Cities Container Corporation 066229618 RELABEL (62032-537), REPACK (62032-537)

Revised: 10/2019 Obagi Cosmeceuticals LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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