OBAGI NU-DERM FX SYSTEM - NORMAL TO DRY- octinoxate, zinc oxide kit

Obagi Nu-Derm FX System - Normal to Dry by

Drug Labeling and Warnings

Obagi Nu-Derm FX System - Normal to Dry by is a Otc medication manufactured, distributed, or labeled by OMP, Inc., G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Gentle Cleanser 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 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, 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, borago officinalis extract, saponins, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum), yellow 5 (CI 19140)

Toner AM+PM

An essential step in your daily skin care routine, this alcohol-free, nondrying toner helps adjust your skin’s pH. 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. Shake before use. Saturate a cotton pad and gently wipe over the 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, potassium alum, sodium PCA, panthenol, DMDM hydantoin, polysorbate 80, allantoin, glycerin, salvia officinalis (sage) leaf extract, borago officinalis extract, calendula officinalis flower extract, saponins, iodopropynyl butylcarbamate, fragrance (parfum), blue 1 (CI 42090)

Nu-Derm Clear Fx™ (Skin Brightening Cream) AM+PM

Clear Fx is a brightening cream specially formulated with arbutin and antioxidants. This gentle formula helps to improve the appearance of the skin for a more even and healthier-looking complexion.

Directions

Use daily, in the morning and evening. Squeeze a small amount (approximately 1 to 2 pea-size drops) 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.

Warnings

Avoid getting into eyes. For external use only. Keep out of reach of children.

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

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.

Ingredients

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

Exfoderm® (Skin Smoothing Lotion) AM

A lightweight lotion that exfoliates the top layer of skin, removing dull, old skin cells while revealing 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 to 2 pea-size 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, ethoxydiglycol, glycerin, phytic acid, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, magnesium aluminum silicate, canola oil, isohexadecane, potassium cetyl phosphate, cetyl alcohol, bis-diglyceryl polyacyladipate-2, dimethicone, sodium hydroxide, xanthan gum, phenoxyethanol, glycereth-7, polysorbate 60, methylparaben, PEG-150 stearate, stearth-20, tocopheryl acetate, saponins, ethylparaben, butylparaben, isobutylparaben, propylparaben

Hydrate (Facial Moisturizer) AM+PM

Obagi Hydrate® provides all-day moisture protection and is suitable for all skin types. Contains Hydromanil, a multi-action agent derived from tara seed, known to gradually deliver moisture to the skin. Also includes shea butter, mango butter, avocado, and glycerin to help combat skin dryness.

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

Nu-Derm Blend Fx™ (Skin Brightener and Blending Cream) PM

A unique formula containing arbutin, antioxidants, and an exfoliant for the gradual brightening of sun spots, age spots, and other types of hyperpigmentation (discoloration). Specially formulated to optimize the delivery of product ingredients in the Obagi Nu-Derm Fx System, this skin brightener helps diminish the visible signs of skin aging.

Directions

Use daily in the evening. Squeeze a small amount (approximately 1 to 2 pea-size drops 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.

Warnings

Avoid getting into eyes. For external use only. Keep out of reach of children.

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

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.

Ingredients

water (aqua), glycerin, cetyl alcohol, arbutin, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, tocopheryl acetate, ascorbic acid, lactic acid, phenyl trimethicone, sodium metabisulfite, BHT, saponins, disodium EDTA, methylparaben, propylparaben

Sun Shield Matte Broad Spectrum SPF 50 AM

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

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 FX™

SYSTEM

NORMAL DRY

Skin Transformation Kit

Complexion Brightening System

INGREDIENTS AND APPEARANCE

OBAGI NU-DERM FX SYSTEM - NORMAL TO DRY 
octinoxate, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-527

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-527-07	1 in 1 CARTON; Type 0: Not a Combination Product	11/04/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	85 g
Part 2		198
Part 3		198
Part 4		57
Part 5		57
Part 6		48
Part 7		57

Part 1 of 7

OBAGI NU-DERM  SUN SHIELD MATTE BROAD SPECTRUM SPF 50
sunscreen lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	105 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG-40 STEARATE (UNII: ECU18C66Q7)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)
SQUALANE (UNII: GW89575KF9)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TROPOLONE (UNII: 7L6DL16P1T)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352

Part 2 of 7

OBAGI NU-DERM  GENTLE CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	GLYCERETH-7 (UNII: 3D2Y91QZ2H)
INGR	APRICOT KERNEL OIL (UNII: 54JB35T06A)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
INGR	OLEYL LACTATE (UNII: B3AWW0N3GM)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	SAGE (UNII: 065C5D077J)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 3 of 7

OBAGI NU-DERM  TONER
other skin care preparations

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	POTASSIUM ALUM (UNII: 1L24V9R23S)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	POLYSORBATE 80 (UNII: 6OZP39ZG8H)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SAGE (UNII: 065C5D077J)
INGR	CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 4 of 7

OBAGI NU-DERM  CLEAR FX
other skin care preparations

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	ARBUTIN (UNII: C5INA23HXF)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM LAURYL SULFATE (UNII: 368GB5141J)
INGR	STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	SODIUM METABISULFITE (UNII: 4VON5FNS3C)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 5 of 7

OBAGI NU-DERM  EXFODERM
other skin care preparations

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	FYTIC ACID (UNII: 7IGF0S7R8I)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	CANOLA OIL (UNII: 331KBJ17RK)
INGR	ISOHEXADECANE (UNII: 918X1OUF1E)
INGR	POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	GLYCERETH-7 (UNII: 3D2Y91QZ2H)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PEG-150 STEARATE (UNII: 7BSG7DF10Q)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ETHYLPARABEN (UNII: 14255EXE39)
INGR	BUTYLPARABEN (UNII: 3QPI1U3FV8)
INGR	ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 6 of 7

OBAGI NU-DERM  HYDRATE
moisturizing

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	SACCHARIDE ISOMERATE (UNII: W8K377W98I)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	SOY STEROL (UNII: PL360EPO9J)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
INGR	CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
INGR	SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	LAURETH-12 (UNII: OAH19558U1)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 7 of 7

OBAGI NU-DERM  BLEND FX
other skin care preparations

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	ARBUTIN (UNII: C5INA23HXF)
INGR	PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
INGR	SODIUM LAURYL SULFATE (UNII: 368GB5141J)
INGR	TROLAMINE SALICYLATE (UNII: H8O4040BHD)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
INGR	SODIUM METABISULFITE (UNII: 4VON5FNS3C)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)

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
OTC monograph final	part352	11/04/2015

Labeler - OMP, Inc. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(62032-527) , LABEL(62032-527) , PACK(62032-527) , ANALYSIS(62032-527)