ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS- avobenzone, octinoxate, and oxybenzone kit

ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM Correct, protect and prevent aging hands by

Drug Labeling and Warnings

ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM Correct, protect and prevent aging hands by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., PAKLAB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%		Sunscreen
Octinoxate 7.5%		Sunscreen
Oxybenzone 2.0%		Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions) decreases the risk of of skin cancer and early aging caused by the sun.

Warnings

For external use only.

Do not use on damaged skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop using this product if skin rash occurs.

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

• Protect the product in this container from excessive heat and direct sunlight
• You may report a serious adverse reaction event from using this product to ZO Skin Health, Inc. 1 Technology Drive, Irvine, CA 92618

Inactive ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C12-15 Alkyl Benzoate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Pentylene Glycol, Polysorbate 60, Cetyl Alcohol, Stearic Acid, Dimethicone, Phenoxyethanol, Ceteth-10 Phosphate, Dicetyl Phosphate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Ethylhexyl Palmitate, Aminomethyl Propanol, Butylene Glycol, Fragrance (Parfum), Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium PCA, Sodium Lactate, Capryloyl Glycine, Dipotassium Glycyrrhizate, Laminaria Ochroleuca Extract, Sodium Ascorbate, Tocopherol, Undecylenoyl Glycine, Arginine, Aspartic Acid, Disodium EDTA, PCA, Retinol, Carbomer, Glycine, Silica Dimethyl Silylate, Alanine, Polysorbate 20, Serine, Valine, Isoleucine, Proline, Threonine, Diacetyl Boldine, Histidine, Phenylalanine, Sodium Hyaluronate, Ubiquinone, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7.

SPL UNCLASSIFIED SECTION

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI, MD

ORASER® ANTI-AGING HAND CARE PROGRAM

Correct, protect and prevent aging hands

beverly hills

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS 
avobenzone, octinoxate, and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-151

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-151-04	1 in 1 CARTON	04/01/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 JAR	15 g
Part 2	1 TUBE	40 mL
Part 3	1 TUBE	40 mL

Part 1 of 3

ZO SKIN HEALTH ORASER MICRODERM HAND RENEWAL 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SUCROSE (UNII: C151H8M554)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	SAFFLOWER OIL (UNII: 65UEH262IS)
INGR	MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
INGR	DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)
INGR	GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
INGR	TRIBEHENIN (UNII: 8OC9U7TQZ0)
INGR	CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	UBIDECARENONE (UNII: EJ27X76M46)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	RETINOL (UNII: G2SH0XKK91)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	MANNITOL (UNII: 3OWL53L36A)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	HYPROMELLOSES (UNII: 3NXW29V3WO)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	FRAGARIN (UNII: 0416TL8388)
INGR	ULTRAMARINE BLUE (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2012

Part 2 of 3

ZO SKIN HEALTH ORASER OVERNIGHT HAND RECOVERY 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
INGR	MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
INGR	STEARIC ACID (UNII: 4ELV7Z65AP)
INGR	CETYL PHOSPHATE (UNII: VT07D6X67O)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
INGR	HEXYLDECANOL (UNII: 151Z7P1317)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)
INGR	AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	FRAGARIN (UNII: 0416TL8388)
INGR	CHLORPHENESIN (UNII: I670DAL4SZ)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	UREA (UNII: 8W8T17847W)
INGR	GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
INGR	ALOE (UNII: V5VD430YW9)
INGR	SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	ARGININE (UNII: 94ZLA3W45F)
INGR	CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
INGR	ASPARTIC ACID (UNII: 30KYC7MIAI)
INGR	PIDOLIC ACID (UNII: SZB83O1W42)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	GLYCINE (UNII: TE7660XO1C)
INGR	ALANINE (UNII: OF5P57N2ZX)
INGR	RAPESEED STEROL (UNII: B46B6DD20U)
INGR	SERINE (UNII: 452VLY9402)
INGR	VALINE (UNII: HG18B9YRS7)
INGR	DIACETYL BOLDINE (UNII: 37727Z7M0I)
INGR	ISOLEUCINE (UNII: 04Y7590D77)
INGR	PROLINE (UNII: 9DLQ4CIU6V)
INGR	THREONINE (UNII: 2ZD004190S)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	HISTIDINE (UNII: 4QD397987E)
INGR	PHENYLALANINE (UNII: 47E5O17Y3R)
INGR	UBIDECARENONE (UNII: EJ27X76M46)
INGR	SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	RETINOL (UNII: G2SH0XKK91)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/01/2012

Part 3 of 3

ORASER DAILY HAND REPAIR BROAD-SPECTRUM SPF 20 SUNSCREEN 
avobenzone, octinoxate, and oxybenzone lotion

Product Information
Item Code (Source)	NDC: 42851-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Glycerin (UNII: PDC6A3C0OX)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Shea Butter (UNII: K49155WL9Y)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Styrene (UNII: 44LJ2U959V)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Pentylene Glycol (UNII: 50C1307PZG)
Polysorbate 60 (UNII: CAL22UVI4M)
Cetyl Alcohol (UNII: 936JST6JCN)
Stearic Acid (UNII: 4ELV7Z65AP)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ceteth-10 Phosphate (UNII: 4E05O5N49G)
Dihexadecyl Phosphate (UNII: 2V6E5WN99N)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Ethylhexyl Palmitate (UNII: 2865993309)
Aminomethylpropanol (UNII: LU49E6626Q)
Butylene Glycol (UNII: 3XUS85K0RA)
Panthenol (UNII: WV9CM0O67Z)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Sodium Lactate (UNII: TU7HW0W0QT)
Capryloyl Glycine (UNII: 8TY5YO42NJ)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Laminaria Ochroleuca (UNII: 4R2124HE76)
Sodium Ascorbate (UNII: S033EH8359)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-050-04	40 mL 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	01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2013

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PAKLAB		790530976	MANUFACTURE(42851-151)