ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS

Main information

  • Trade name:
  • ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS- avobenzone, octinoxate, and oxybenz
  • Composition:
  • Avobenzone 30 mg in 1 mL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS- avobenzone, octinoxate, and oxybenz
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • - 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.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 42851-050-04, 42851-151-04
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT,

PROTECT AND PREVENT AGING HANDS- avobenzone, octinoxate, and oxybenzone

ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM Correct, protect and

prevent aging hands

Drug Facts

Active ingredients

Purpose

Avobenzone 3.0%

Sunscreen

Octinoxate 7.5%

Sunscreen

Oxybenzone 2.0%

Sunscreen

Us es

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:

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

®

®

Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeved shirts, pants, hats and sunglasses

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.

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

®

ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT,

PROTECT AND PREVENT AGING HANDS

avobenzone, octinoxate, and oxybenzone kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:428 51-151

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:428 51-151-0 4

1 in 1 CARTON

0 4/0 1/20 13

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 JAR

15 g

Pa rt 2

1 TUBE

40 mL

Pa rt 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

SUCRO SE (UNII: C151H8 M554)

INGR

SHEA BUTTER (UNII: K49 155WL9 Y)

INGR

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

INGR

MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9 M35X2)

INGR

DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D8 18 OLQ51Z)

INGR

GLYCERYL DIBEHENATE (UNII: R8 WTH25YS2)

INGR

TRIBEHENIN (UNII: 8 OC9 U7TQZ0 )

INGR

CETYL DIMETHICO NE 2 5 (UNII: U4AS1BW4ZB)

INGR

SALICYLIC ACID (UNII: O414PZ4LPZ)

INGR

UBIDECARENO NE (UNII: EJ27X76 M46 )

INGR

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

INGR

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

INGR

RETINO L (UNII: G2SH0 XKK9 1)

INGR

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

INGR

MANNITO L (UNII: 3OWL53L36 A)

INGR

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

INGR

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

INGR

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

INGR

TO CO PHERO L (UNII: R0 ZB2556 P8 )

INGR

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

INGR

FRAGARIN (UNII: 0 416 TL8 38 8 )

INGR

ULTRAMARINE BLUE (UNII: I39 WR9 9 8 BI)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

15 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

0 1/0 1/20 12

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: 0 59 QF0 KO0 R)

INGR

DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D8 18 OLQ51Z)

INGR

GLYCERIN (UNII: PDC6 A3C0 OX)

INGR

SHEA BUTTER (UNII: K49 155WL9 Y)

INGR

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

INGR

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

INGR

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

INGR

NIACINAMIDE (UNII: 25X51I8 RD4)

INGR

TETRAHEXYLDECYL ASCO RBATE (UNII: 9 LBV3F0 7AZ)

INGR

MEADO WFO AM SEED O IL (UNII: 412ZHA4T4Y)

INGR

STEARIC ACID (UNII: 4ELV7Z6 5AP)

INGR

CETYL PHO SPHATE (UNII: VT0 7D6 X6 7O)

INGR

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

INGR

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

INGR

MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9 M35X2)

INGR

HEXYLDECANO L (UNII: 151Z7P1317)

INGR

AVO CADO O IL (UNII: 6 VNO72PFC1)

INGR

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

INGR

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

INGR

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

INGR

FRAGARIN (UNII: 0 416 TL8 38 8 )

INGR

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

INGR

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

INGR

UREA (UNII: 8 W8 T178 47W)

INGR

GLUCO SAMINE HYDRO CHLO RIDE (UNII: 750 W5330 FY)

INGR

ALO E (UNII: V5VD430 YW9 )

INGR

SACCHARO MYCES CEREVISIAE (UNII: 9 78 D8 U419 H)

INGR

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

INGR

SO DIUM LACTATE (UNII: TU7HW0 W0 QT)

INGR

LEVO MENO L (UNII: 24WE0 3BX2T)

INGR

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

INGR

ARGININE (UNII: 9 4ZLA3W45F)

INGR

CETYLHYDRO XYPRO LINE PALMITAMIDE (UNII: 74ONU0 S6 2G)

INGR

ASPARTIC ACID (UNII: 30 KYC7MIAI)

INGR

PIDO LIC ACID (UNII: SZB8 3O1W42)

INGR

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

INGR

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

INGR

GLYCINE (UNII: TE76 6 0 XO1C)

INGR

ALANINE (UNII: OF5P57N2ZX)

INGR

RAPESEED STERO L (UNII: B46 B6 DD20 U)

INGR

SERINE (UNII: 452VLY9 40 2)

INGR

VALINE (UNII: HG18 B9 YRS7)

INGR

DIACETYL BO LDINE (UNII: 37727Z7M0 I)

INGR

ISO LEUCINE (UNII: 0 4Y759 0 D77)

INGR

PRO LINE (UNII: 9 DLQ4CIU6 V)

INGR

THREO NINE (UNII: 2ZD0 0 419 0 S)

INGR

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

INGR

HISTIDINE (UNII: 4QD39 79 8 7E)

INGR

PHENYLALANINE (UNII: 47E5O17Y3R)

INGR

UBIDECARENO NE (UNII: EJ27X76 M46 )

INGR

SILICA DIMETHYL SILYLATE (UNII: EU2PSP0 G0 W)

INGR

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

INGR

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

INGR

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

INGR

RETINO L (UNII: G2SH0 XKK9 1)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

40 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

0 1/0 1/20 12

Part 3 of 3

ORASER DAILY HAND REPAIR BROAD-SPECTRUM SPF 20 SUNSCREEN

avobenzone, octinoxate, and oxybenzone lotion

Product Information

Ite m Code (Source )

NDC:428 51-0 50

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Avo benzo ne (UNII: G6 3QQF2NOX) (Avo benzo ne - UNII:G6 3QQF2NOX)

Avo be nz o ne

30 mg in 1 mL

O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51)

O c tino xa te

75 mg in 1 mL

O xybenzo ne (UNII: 9 5OOS7VE0 Y) (Oxybenzo ne - UNII:9 5OOS7VE0 Y)

O xybe nz o ne

20 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Medium-Cha in Trig lycerides (UNII: C9 H2L21V7U)

Glycerin (UNII: PDC6 A3C0 OX)

Alkyl ( C12 -15) Benzo a te (UNII: A9 EJ3J6 1HQ)

Shea Butter (UNII: K49 155WL9 Y)

Ceto stea ryl Alco ho l (UNII: 2DMT128 M1S)

Styrene (UNII: 44LJ2U9 59 V)

Butylo ctyl Sa licyla te (UNII: 2EH13UN8 D3)

Pentylene Glyco l (UNII: 50 C130 7PZG)

Po lyso rba te 6 0 (UNII: CAL22UVI4M)

Cetyl Alco ho l (UNII: 9 36 JST6 JCN)

ZO Skin Health, Inc.

Stea ric Acid (UNII: 4ELV7Z6 5AP)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Ceteth-10 Pho spha te (UNII: 4E0 5O5N49 G)

Dihexa decyl Pho spha te (UNII: 2V6 E5WN9 9 N)

.Alpha .-To co phero l Aceta te (UNII: 9 E8 X8 0 D2L0 )

Tetra hexyldecyl Asco rba te (UNII: 9 LBV3F0 7AZ)

Ethylhexyl Pa lmita te (UNII: 28 6 59 9 330 9 )

Amino methylpro pa no l (UNII: LU49 E6 6 26 Q)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

Pa ntheno l (UNII: WV9 CM0 O6 7Z)

Ca rbo mer Interpo lymer Type A ( Allyl Sucro se Cro sslinked) (UNII: 59 TL3WG5CO)

So dium Pyrro lido ne Ca rbo xyla te (UNII: 46 9 OTG57A2)

So dium La cta te (UNII: TU7HW0 W0 QT)

Ca prylo yl Glycine (UNII: 8 TY5YO42NJ)

Glycyrrhizina te Dipo ta ssium (UNII: CA2Y0 FE3FX)

La mina ria O chro leuca (UNII: 4R2124HE76 )

So dium Asco rba te (UNII: S0 33EH8 359 )

To co phero l (UNII: R0 ZB2556 P8 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:428 51-0 50 -0 4

40 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 1/0 1/20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 3/0 1/20 13

Labeler -

ZO Skin Health, Inc. (826468527)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

PAKLAB

79 0 530 9 76

MANUFACTURE(428 51-151)

Revised: 4/2016