OTC Medication Information: Obagi Medical – Nu-Derm System – Normal to Dry – Skin Transformation Trial Kit (Page 2 of 2)

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 prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY

Sun Shield Broad Spectrum SPF 50 Matte

Drug Facts

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 a.m.–2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

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

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, phenoxyethanol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, sodium polyacrylate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tropolone, water, xanthan gum

Questions or comments?

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

Principal Display Panel — Kit Carton

OBAGI®

MEDICAL

OBAGI NU-DERM® SYSTEM

NORMAL DRY

Skin Transformation Trial Kit

Obagi Medical -- Nu-Derm System -- Normal to Dry -- Skin Transformation Trial Kit
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
Obagi Nu-DermGentle Cleanser Cleansing (cold creams, cleansing lotions, liquids, and pads)
Obagi Nu-DermToner Cleansing (cold creams, cleansing lotions, liquids, and pads)
Obagi Nu-DermExfoderm Cleansing (cold creams, cleansing lotions, liquids, and pads)
OBAGI MEDICAL — NU-DERM SYSTEM — NORMAL TO DRY — SKIN TRANSFORMATION TRIAL KIT
octinoxate, zinc oxide kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-528
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-528-07 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 28 g
Part 2 1 BOTTLE, PLASTIC 57 g
Part 3 1 BOTTLE, PLASTIC 28 g
Part 4 59
Part 5 59
Part 6 28
Part 1 of 6
OBAGI NU-DERM SUN SHIELD MATTE BROAD SPECTRUM SPF 50
sunscreen lotion
Product Information
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
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
CHLORPHENESIN
CITRIC ACID MONOHYDRATE
CYCLOMETHICONE 5
DIMETHICONE
EDETATE DISODIUM
GLYCERIN
HYDROGENATED PALM GLYCERIDES
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
METHYLISOTHIAZOLINONE
PEG-40 STEARATE
PENTYLENE GLYCOL
PHENOXYETHANOL
PHENYL TRIMETHICONE
POLYSORBATE 60
POTASSIUM SORBATE
SODIUM BENZOATE
SODIUM DIHYDROXYCETYL PHOSPHATE
SQUALANE
STEARYL ALCOHOL
TETRAHEXYLDECYL ASCORBATE
TROPOLONE
WATER
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352
Part 2 of 6
NU-DERM CLEAR SKIN BLEACHING AND CORRECTOR
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
WATER
CETYL ALCOHOL
GLYCERIN
SODIUM LAURYL SULFATE
STEARYL ALCOHOL
LACTIC ACID
.ALPHA.-TOCOPHEROL ACETATE
ASCORBIC ACID
SODIUM METABISULFITE
EDETATE DISODIUM
METHYLPARABEN
BUTYLATED HYDROXYTOLUENE
PROPYLPARABEN
BUTYLPARABEN
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 01/01/1988
Part 3 of 6
NU-DERM BLENDER SKIN LIGHTENER AND BLENDING
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
WATER
GLYCERIN
CETYL ALCOHOL
PPG-2 MYRISTYL ETHER PROPIONATE
SODIUM LAURYL SULFATE
TROLAMINE SALICYLATE
LACTIC ACID
PHENYL TRIMETHICONE
.ALPHA.-TOCOPHEROL ACETATE
SODIUM METABISULFITE
ASCORBIC ACID
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 28 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/1988
Part 4 of 6
OBAGI NU-DERM GENTLE CLEANSER
cleanser
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
COCAMIDOPROPYL BETAINE
GLYCERIN
SODIUM LAUROYL OAT AMINO ACIDS
ALOE VERA LEAF
SODIUM LAURETH-3 SULFATE
GLYCERETH-7
APRICOT KERNEL OIL
PANTHENOL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
OLEYL LACTATE
DIETHYLENE GLYCOL MONOETHYL ETHER
SAGE
BORAGE
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
PROPYLPARABEN
ISOBUTYLPARABEN
FD&C YELLOW NO. 5
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Part 5 of 6
OBAGI NU-DERM TONER
toner
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
HAMAMELIS VIRGINIANA TOP WATER
ALOE VERA LEAF
POTASSIUM ALUM
SODIUM PYRROLIDONE CARBOXYLATE
PANTHENOL
DMDM HYDANTOIN
POLYSORBATE 80
ALLANTOIN
GLYCERIN
SAGE
BORAGE
CALENDULA OFFICINALIS FLOWER
IODOPROPYNYL BUTYLCARBAMATE
FD&C BLUE NO. 1
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Part 6 of 6
OBAGI NU-DERM EXFODERM
skin smoothing lotion
Product Information
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCERIN
FYTIC ACID
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
MAGNESIUM ALUMINUM SILICATE
CANOLA OIL
ISOHEXADECANE
POTASSIUM CETYL PHOSPHATE
CETYL ALCOHOL
DIMETHICONE
SODIUM HYDROXIDE
XANTHAN GUM
PHENOXYETHANOL
GLYCERETH-7
POLYSORBATE 60
METHYLPARABEN
PEG-150 STEARATE
STEARETH-20
.ALPHA.-TOCOPHEROL ACETATE
ETHYLPARABEN
BUTYLPARABEN
ISOBUTYLPARABEN
PROPYLPARABEN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/16/2015
Labeler — Obagi Cosmeceuticals LLC (790553353)
Establishment
Name Address ID/FEI Operations
G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE (62032-528)
Establishment
Name Address ID/FEI Operations
Bay Cities Container Corporation 066229618 RELABEL (62032-528), REPACK (62032-528)

Revised: 11/2019 Obagi Cosmeceuticals LLC

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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.

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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