NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION- hydroquinone, octinoxate,and zinc oxide 
OMP, INC.

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.

----------

NU-DERM® SYSTEM NORMAL-DRY
SKIN TRANSFORMATION KIT

Gentle Cleanser 6.7 fl. oz. (198 mL.) AM+PM

A mild facial cleanser that provides gentle yet effective cleansing for normal to dry skin. For skin that's beautifully clean and fresh, the Nu-Derm Gentle Cleanser instantly dissolves excess oil, makeup, and other everyday impurities, without stripping your skin of its natural protective oils, and prepares your skin for the next step in your skin care regimen.

Directions

Use twice daily, morning and evening. Massage a small amount of cleanser and water onto skin. Rinse 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), cocamidopropyl betaine, glycerin, sodium lauroyl oat amino acids, aloe barbadensis leaf juice (aloe barbadensis), sodium laureth sulfate, glycereth-7, prunus armeniaca (apricot) kernel oil, panthenol, acrylates/C10-30 alkyl acrylate crosspolymer, oleyl lactate, ethoxydiglycol, triethanolamine, salvia officinalis (sage) leaf extract (salvia officinalis), borago officinalis extract, saponins, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), yellow 5 (CI 19140)

Toner 6.7 fl. oz. (198 mL.) AM+PM

An essential step in your daily skin care routine, this alcohol-free, non-drying toner helps adjust your skin's pH for increased penetration of product ingredients. Use after cleansing to remove impurities and dead skin cells and to prepare the skin for hydration or appropriate products.

Directions

Use daily, in the morning and evening after cleansing. Saturate a cotton pad and gently wipe over entire face. 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, aloe barbadensis leaf juice (aloe barbadensis), potassium alum, sodium PCA, panthenol, DMDM hydantoin, polysorbate 80, allantoin, glycerin, salvia officinalis (sage) leaf extract (salvia officinalis), borago officinalis extract, calendula officinalis flower extract (calendula officinalis), saponins, iodopropynyl butylcarbamate, fragrance (parfum), blue 1 (CI 42090)

Clear (Skin Bleaching and Corrector Cream) NDC 62032-101-36 Net wt. 2 oz. (57 g.) Hydroquinone USP, 4% Rx Only AM+PM

Dark spots may appear on the surface of your skin, but they actually start deep within the skin's layers. This gentle yet effective formula absorbs into the layers of your skin to deliver prescription-strength hydroquinone, helping to correct the appearance of age and sun spots for a healthier, more even complexion.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

Dosage and administration

Use daily, in the morning and evening. Squeeze a small amount (approximately 1-2 pea-sized amounts) onto your hand. Apply evenly to the entire face, extending to the hairline, over the ears, and ending with a feathering motion, or as directed by your physician. 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.

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 Nu-Derm Clear contains:

Active ingredient

Hydroquinone USP, 4% (40 mg/g)

Inactive ingredients

water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben

See enclosed Package Insert for full prescribing information.

Rx ONLY. FOR EXTERNAL USE ONLY.

Exfoderm® (Skin Smoothing Lotion) Net wt. 2 oz. (57 g.) AM

A lightweight lotion that exfoliates the top layer of skin, removing dull, old skin cells while promoting new skin cells for a brighter complexion. Specifically developed for normal to dry skin, this gentle, skin-enhancing formula contains a plant acid (phytic acid) to help transform the appearance of damaged skin and reveal your skin's radiance.

Directions

Use daily, in the morning. Squeeze a small amount (approximately 1-2 pea-sized drops) onto your hands. Using your fingertips, apply evenly to the entire face. Massage until completely absorbed.

Warnings

Avoid getting into eyes. For external use only.

Keep out of reach of children.

Ingredients

water (aqua), ethoxydiglycol, glycerin, phytic acid, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, canola oil, isohexadecane, magnesium aluminum silicate, potassium cetyl phosphate, cetyl alcohol, bis-diglyceryl polyacyladipate-2, dimethicone, polysorbate 60, PEG-150 stearate, steareth-20, xanthan gum, glycereth-7, tocopheryl acetate, saponins, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben

Hydrate (Facial Moisturizer) Net wt. 1.7 oz. (48 g.) AM+PM

A multi-action moisturizer with Hydromanil, a natural moisturizing agent derived from tara seed known to gradually deliver moisture to the skin. Also contains shea butter, mango butter, avocado and glycerin to help combat skin dryness. Suitable for all skin types.

Directions

Apply to face in the morning and evening or as needed.

Warnings

Avoid getting into eyes. For external use only.

Keep out of reach of children.

Ingredients

water (aqua), glycerin, caprylic/capric triglyceride, butyrospermum parkii (shea) butter, cyclopentasiloxane, glyceryl stearate, cetyl alcohol, dimethicone, saccharide isomerate, stearic acid, polysilicone-11, glycine soja (soybean) sterols, persea gratissima (avocado) oil, mangifera indica (mango) seed butter, hydrolyzed caesalpinia spinosa gum, caesalpinia spinosa gum, hydrolyzed soybean fiber, sodium stearoyl glutamate, caprylyl glycol, bisabolol, allantoin, tocopherol, tetrahydrodiferuloylmethane, panthenol, carbomer, hexylene glycol, sodium hydroxide, laureth-12, ethylhexylglycerin, phenoxyethanol

Blender® (Skin Lightener and Blending Cream) NDC 62032-100-36 Net wt. 2 oz. (57 g.) Hydroquinone USP, 4% Rx Only PM

A unique formula containing prescription-strength hydroquinone for the gradual lightening of sun spots, age spots, and other types of hyperpigmentation (discoloration). Specially formulated to optimize the delivery of product ingredients in the Nu-Derm System, this skin lightener helps reduce the signs of aging and correct uneven skin tone. May be used with Tretinoin Cream1 or Refissa2 as prescribed by a physician.


1
Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
2
Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs. REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN.

Indications and usage

The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Specially formulated for blending purposes as part of the Obagi Nu-Derm System.

Dosage and administration

Use daily, in the evening. Squeeze a small amount (approximately 1-2 pea-sized drops) onto your hand. Apply evenly to the entire face, or as directed by your skin care physician. 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.

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 Nu-Derm Blender 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.

Sun Shield Matte Broad Spectrum SPF 50 Net wt. 3 oz. (85 g.)

This sunscreen combines UVB absorption and UVA protection in an elegant, matte finish that is non-comedogenic, allergy tested, and dermatologist tested. Sheer, PABA free, and fragrance free for all skin types.

Drug Facts

Active ingredientsPurpose
Octinoxate 7.5%Sunscreen
Zinc Oxide 10.5%Sunscreen

Uses

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

Inactive ingredients

1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum

Other information

Questions or comments?

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

Travel Bag and Patient Instruction Guide

Store at controlled room temperature 15°C–25°C (59°F–77°F).

Blender, Exfoderm, Nu-Derm, Obagi and the Obagi logo
are registered trademarks of OMP, Inc.

Refissa is a registered trademark or Spear Pharmaceuticals, Inc.
Distributed by OMP, Inc., Long Beach, CA 90806

©2012 Obagi Medical Products, Inc. All Rights Reserved.
OBAGI.COM Made in USA 41706110Z 7061

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC# 62032-514-00

OBAGI®
MEDICAL

NU-DERM® SYSTEM

NORMAL DRY

Skin Transformation Kit

PRINCIPAL DISPLAY PANEL - Kit Carton
NU-DERM SYSTEM NORMAL-DRY  SKIN TRANSFORMATION
hydroquinone, octinoxate,and zinc oxide kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62032-514
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-514-001 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 57 g
Part 21 BOTTLE, PLASTIC 57 g
Part 31 TUBE 85 g
Part 41 BOTTLE, PLASTIC 198 mL
Part 51 BOTTLE, PLASTIC 198 mL
Part 61 BOTTLE, PLASTIC 57 g
Part 71 BOTTLE, PLASTIC 48 g
Part 1 of 7
NU-DERM BLENDER  SKIN LIGHTENER AND BLENDING
hydroquinone cream
Product Information
Item Code (Source)NDC:62032-100
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
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-100-3657 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/1988
Part 2 of 7
NU-DERM CLEAR  SKIN BLEACHING AND CORRECTOR
hydroquinone cream
Product Information
Item Code (Source)NDC:62032-101
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
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-101-3657 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/1988
Part 3 of 7
NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50  MATTE SUNSCREEN
octinoxate and zinc oxide lotion
Product Information
Item Code (Source)NDC:62032-104
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 (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-104-9085 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/07/2012
Part 4 of 7
NU-DERM GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
INGRTROLAMINE (UNII: 9O3K93S3TK)  
INGRSAGE (UNII: 065C5D077J)  
INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
INGROLEYL LACTATE (UNII: B3AWW0N3GM)  
INGRCARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1198 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/1988
Part 5 of 7
NU-DERM TONER 
face and neck (excluding shaving preparations) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGRPOTASSIUM ALUM (UNII: 1L24V9R23S)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSAGE (UNII: 065C5D077J)  
INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
INGRHAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1198 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/1988
Part 6 of 7
NU-DERM EXFODERM 
face and neck (excluding shaving preparations) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRCANOLA OIL (UNII: 331KBJ17RK)  
INGRISOHEXADECANE (UNII: 918X1OUF1E)  
INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRFYTIC ACID (UNII: 7IGF0S7R8I)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRPEG-150 STEARATE (UNII: 7BSG7DF10Q)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRBUTYLPARABEN (UNII: 3QPI1U3FV8)  
INGRETHYLPARABEN (UNII: 14255EXE39)  
INGRISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
INGRPOTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRGLYCERETH-7 (UNII: 3D2Y91QZ2H)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
157 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/1988
Part 7 of 7
NU-DERM HYDRATE  FACIAL MOISTURIZER
face and neck (excluding shaving preparations) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRCAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRSACCHARIDE ISOMERATE (UNII: W8K377W98I)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRLAURETH-12 (UNII: OAH19558U1)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGRSOY STEROL (UNII: PL360EPO9J)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
INGRSODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRTETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
148 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/07/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/07/2012
Labeler - OMP, INC. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
MILBAR LABORATORIES195556790MANUFACTURE(62032-514)
Establishment
NameAddressID/FEIBusiness Operations
PURETEK CORPORATION785961046MANUFACTURE(62032-514) , LABEL(62032-514) , PACK(62032-514)
Establishment
NameAddressID/FEIBusiness Operations
Ei INC.105803274MANUFACTURE(62032-514) , LABEL(62032-514) , PACK(62032-514) , ANALYSIS(62032-514)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-514)
Establishment
NameAddressID/FEIBusiness Operations
Bay Cities Container Corporation066229618RELABEL(62032-514) , REPACK(62032-514)

Revised: 12/2012
Document Id: 53845d82-8e3c-4498-89e0-1568174f8524
Set id: 7e70faa2-ce6a-4815-9fa1-43c7025d80e6
Version: 1
Effective Time: 20121228
 
OMP, INC.