ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING

Main information

  • Trade name:
  • ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING- titanium dioxide
  • Composition:
  • Titanium Dioxide 0.08 g in 1 g
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING- titanium dioxide
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Sunscreen - 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.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 42851-052-60, 42851-158-60
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN

BRIGHTENING- titanium dioxide

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 MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin

Brightening

Drug Facts

Active ingredient

Titanium Dioxide 8%

Purpos e

Sunscreen

Us es

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 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.

Other information

Store product in a cool place away from direct heat and sunlight.

You may report a serious adverse reaction to: 5 Technology Dr. #100, Irvine, CA 92618

Directions

For full protection, apply liberally 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

For children under 6 months of age: 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.

Apply to all skin exposed to the sun.

Inactive ingredients

Water, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone,

Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol,

Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate,

Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100

Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides,

Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate,

Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja

(Soybean) extract, Silica, C13-14 Isoparaffin, Laureth-7.

DIST BY

ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO MEDICAL

BY ZEIN OBAGI MD

NDC 42851-158-60

ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM

For Skin Brightening

Wear long-sleeved shirts, pants, hats and sunglasses.

®

®

ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM

FOR SKIN BRIGHTENING

titanium dioxide kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:428 51-158

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:428 51-158 -6 0

1 in 1 CARTON

11/0 1/20 15

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 TUBE, WITH APPLICATOR

50 mL

Pa rt 2

1 TUBE

30 mL

Pa rt 3

1 BOTTLE, PUMP

30 mL

Pa rt 4

1 TUBE

6 0 g

Part 1 of 4

ZO MEDICAL C-BRIGHT SERUM VITAMIN C

cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ing re die nt

Kind

Ingredient Name

Quantity

INGR

Cyclo methico ne 5 (UNII: 0 THT5PCI0 R)

INGR

Asco rbic Acid (UNII: PQ6 CK8 PD0 R)

INGR

Dimethico ne Cro sspo lymer ( 4 50 0 0 0 Mpa .S At 12 % In Cyclo penta silo xa ne) (UNII:

UF76 20 L1W6 )

INGR

Dimethico ne (UNII: 9 2RU3N3Y1O)

INGR

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

INGR

Bitter O ra ng e O il (UNII: 9 TLV70 SV6 I)

INGR

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

INGR

Squa la ne (UNII: GW8 9 575KF9 )

INGR

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

INGR

Ubideca reno ne (UNII: EJ27X76 M46 )

INGR

Limo nene, ( +) - (UNII: GFD7C8 6 Q1W)

INGR

Citra l (UNII: T7EU0 O9 VPP)

Packag ing

#

Item

Co de

Package Description

Marketing Start

Date

Marketing End

Date

1

50 mL in 1 TUBE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

11/0 1/20 15

Part 2 of 4

ZO MEDICAL BRIGHTALIVE NON-RETINOL SKIN BRIGHTENER

cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

Wa ter (UNII: 0 59 QF0 KO0 R)

INGR

Cyclo methico ne 5 (UNII: 0 THT5PCI0 R)

INGR

Ca prylyl Trisilo xa ne (UNII: Q9 5M2P1KJL)

INGR

Glycerin (UNII: PDC6 A3C0 OX)

INGR

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

INGR

Alpha -Arbutin (UNII: 72VUP0 7IT5)

INGR

Bellis Perennis Flo wer (UNII: 26 I9 4X9 A1K)

INGR

Glyceryl Mo no stea ra te (UNII: 230 OU9 XXE4)

INGR

PEG-10 0 Stea ra te (UNII: YD0 1N19 9 9 R)

INGR

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

INGR

No na peptide-1 (UNII: 6 4W45420 K5)

INGR

Dimethylmetho xy Chro ma nyl Pa lmita te (UNII: 5G222ZDK7U)

INGR

Ubideca reno ne (UNII: EJ27X76 M46 )

INGR

Hexylreso rcino l (UNII: R9 QTB5E8 2N)

INGR

Glycyrrhiza Gla bra (UNII: 278 8 Z9 758 H)

INGR

Sunflo wer O il (UNII: 3W1JG79 5YI)

INGR

Ro sema ry (UNII: IJ6 7X351P9 )

INGR

O lea Euro pa ea Lea f (UNII: MJ9 5C3OH47)

INGR

Sta chys O fficina lis Flo wering To p (UNII: D7A759 WU38 )

INGR

Ma lto dextrin (UNII: 7CVR7L4A2D)

INGR

Lecithin, Sunflo wer (UNII: 8 34K0 WOS5G)

INGR

So y Iso fla vo nes (UNII: 71B37NR0 6 D)

INGR

Po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

INGR

Alco ho l (UNII: 3K9 9 58 V9 0 M)

INGR

Asco rbyl Gluco side (UNII: 2V52R0 NHXW)

INGR

Zinc Pido la te (UNII: C32PQ8 6 DH4)

INGR

Asco rbic Acid (UNII: PQ6 CK8 PD0 R)

INGR

N-Acetylg luco sa mine (UNII: V9 56 6 9 6 549 )

INGR

Hydro g ena ted So ybea n Lecithin (UNII: H110 9 Z9 J4N)

INGR

So dium O lea te (UNII: 39 9 SL0 44HN)

INGR

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

INGR

N-Acetyltyro sine (UNII: DA8 G6 10 ZO5)

INGR

Pro line (UNII: 9 DLQ4CIU6 V)

INGR

Adeno sine Tripho spha te (UNII: 8 L70 Q75FXE)

INGR

Pa pa in (UNII: A236 A0 6 Y32)

INGR

Ca rbo xypo lymethylene (UNII: 0 A5MM30 7FC)

INGR

1,2 -Hexa nedio l (UNII: TR0 46 Y3K1G)

INGR

So dium Alg ina te (UNII: C26 9 C4G2ZQ)

INGR

Po ly( Methyl Metha cryla te; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

INGR

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

INGR

Vita min A Pa lmita te (UNII: 1D1K0 N0 VVC)

INGR

Asco rbyl Pa lmita te (UNII: QN8 3US2B0 N)

INGR

So dium Sulfite (UNII: VTK0 1UQK3G)

INGR

Po lyiso butylene ( 10 0 0 MW) (UNII: 5XB3A6 3Y52)

INGR

Po lyso rba te 2 0 (UNII: 7T1F30 V5YH)

INGR

PEG-12 Dimethico ne/PPG-2 0 Cro sspo lymer (UNII: 9 6 5K72OQXO)

INGR

Dextra n 1 (UNII: I8 LHQ0 D6 45)

INGR

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

INGR

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

INGR

Ca prylyl Glyco l (UNII: 0 0 YIU5438 U)

INGR

Chlo rphenesin (UNII: I6 70 DAL4SZ)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

30 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

11/0 1/20 15

Part 3 of 4

ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE

cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

Wa ter (UNII: 0 59 QF0 KO0 R)

INGR

Cetea ryl Iso no na no a te (UNII: P5O0 1U9 9 NI)

INGR

Cyclo methico ne 5 (UNII: 0 THT5PCI0 R)

INGR

Cyclo methico ne 6 (UNII: XHK3U310 BA)

INGR

Pentylene Glyco l (UNII: 50 C130 7PZG)

INGR

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

INGR

Glycerin (UNII: PDC6 A3C0 OX)

INGR

Stea reth-2 0 (UNII: L0 Q8 IK9 E0 8 )

INGR

Ca rbo xypo lymethylene (UNII: 0 A5MM30 7FC)

INGR

C14 -2 2 Alco ho ls (UNII: B1K8 9 38 4RJ)

INGR

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

INGR

Cetea ryl Gluco side (UNII: 0 9 FUA47KNA)

INGR

Po lyso rba te 2 0 (UNII: 7T1F30 V5YH)

INGR

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

INGR

Pa lmito yl Tetra peptide-7 (UNII: Q41S46 4P1R)

INGR

So dium Hydro xide (UNII: 55X0 4QC32I)

INGR

Ca prylyl Glyco l (UNII: 0 0 YIU5438 U)

INGR

C12 -2 0 Alkyl Gluco side (UNII: K6 7N5Z1RUA)

INGR

Ethylhexylg lycerin (UNII: 147D247K3P)

INGR

La cto se, Unspecified Fo rm (UNII: J2B2A4N9 8 G)

INGR

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

INGR

Po wdered Cellulo se (UNII: SMD1X3XO9 M)

INGR

Hexylene Glyco l (UNII: KEH0 A3F75J)

INGR

Po ta ssium So rba te (UNII: 1VPU26 JZZ4)

INGR

1,2 -Hexa nedio l (UNII: TR0 46 Y3K1G)

INGR

Methylpa ra ben (UNII: A2I8 C7HI9 T)

INGR

Lecithin, Sunflo wer (UNII: 8 34K0 WOS5G)

INGR

Hypro mello ses (UNII: 3NXW29 V3WO)

INGR

So rbito l (UNII: 50 6 T6 0 A25R)

INGR

Edetic Acid (UNII: 9 G34HU7RV0 )

INGR

Benzo ic Acid (UNII: 8 SKN0 B0 MIM)

INGR

So dium Benzo a te (UNII: OJ245FE5EU)

INGR

Ara bido psis Tha lia na (UNII: AI3L6 0 HQ8 1)

INGR

Retino l (UNII: G2SH0 XKK9 1)

INGR

Vita min A Pa lmita te (UNII: 1D1K0 N0 VVC)

INGR

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

INGR

O ra ng e O il (UNII: AKN3KSD11B)

INGR

Lemo n O il (UNII: I9 GRO8 24LL)

INGR

Ma nda rin O il (UNII: NJO720 F72R)

INGR

Peppermint O il (UNII: AV0 9 2KU4JH)

INGR

Mimo sa Tenuiflo ra Ba rk (UNII: 515MQE449 I)

INGR

To co phero l (UNII: R0 ZB2556 P8 )

INGR

Limo nene, ( +) - (UNII: GFD7C8 6 Q1W)

INGR

Ultra ma rine Blue (UNII: I39 WR9 9 8 BI)

INGR

Ext. D&C Vio let No . 2 (UNII: G5UX3K0 728 )

Packag ing

# Item Code

Package Description

Marketing Start Date

Marketing End Date

1

30 mL in 1 BOTTLE, PUMP; 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

11/0 1/20 15

Part 4 of 4

ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50

titanium dioxide lotion

Product Information

Ite m Code (Source )

NDC:428 51-0 52

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium Dio xide (UNII: 15FIX9 V2JP) (Titanium Dio xide - UNII:15FIX9 V2JP)

Titanium Dio xide

0 .0 8 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Aluminum Hydro xide (UNII: 5QB0 T2IUN0 )

Stea ric Acid (UNII: 4ELV7Z6 5AP)

Po lyg lyceryl-3 Po lydimethylsilo xyethyl Dimethico ne ( 4 0 0 0 MPA.S) (UNII: RLA2U0 5Z4Q)

Cyclo methico ne 5 (UNII: 0 THT5PCI0 R)

Phenyl Trimethico ne (UNII: DR0 K5NOJ4R)

Pentylene Glyco l (UNII: 50 C130 7PZG)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Glycerin (UNII: PDC6 A3C0 OX)

Iso decyl Neo penta no a te (UNII: W6 0 VYE24XC)

Diiso pro pyl Seba ca te (UNII: J8 T3X56 4IH)

La uryl La cta te (UNII: G5SU0 BFK7O)

Edeta te Diso dium (UNII: 7FLD9 1C8 6 K)

Phyto sphing o sine (UNII: GIN46 U9 Q2Q)

Po lyo xyl 2 0 Ceto stea ryl Ether (UNII: YRC528 SWUY)

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

PEG-10 0 Stea ra te (UNII: YD0 1N19 9 9 R)

Glyceryl Mo no stea ra te (UNII: 230 OU9 XXE4)

So dium Dihydro xycetyl Pho spha te (UNII: YWI33EV59 5)

Hydro g ena ted Pa lm Glycerides (UNII: YCZ8 EM144Q)

Mela nin Synthetic ( Tyro sine, Pero xide) (UNII: O0 CV1RMR44)

Ethylhexylg lycerin (UNII: 147D247K3P)

Erythrito l (UNII: RA9 6 B9 54X6 )

Ho ma rine Hydro chlo ride (UNII: 8 8 6 6 LNG6 1N)

So dium Benzo a te (UNII: OJ245FE5EU)

Po ta ssium So rba te (UNII: 1VPU26 JZZ4)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Ca prylyl Glyco l (UNII: 0 0 YIU5438 U)

Chlo rphenesin (UNII: I6 70 DAL4SZ)

Nephelium La ppa ceum Fruit Rind (UNII: Y0 513T9 0 FO)

So ybea n (UNII: L7HT8 F1ZOD)

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

C13 -14 Iso pa ra ffin (UNII: E4F12ROE70 )

La ureth-7 (UNII: Z9 5S6 G8 20 1)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:428 51-0 52-6 0

6 0 g 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

11/0 1/20 15

ZO Skin Health, Inc.

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

11/0 1/20 15

Labeler -

ZO Skin Health, Inc. (826468527)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Milbar Labo rato ries, Inc.

19 5556 79 0

MANUFACTURE(428 51-158 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

G.S. COSMECEUTICAL USA, INC.

0 170 14734

MANUFACTURE(428 51-158 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pa kLa b

79 0 530 9 76

MANUFACTURE(428 51-158 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Thibiant Internatio nal, Inc.

0 8 39 139 13

MANUFACTURE(428 51-158 )

Revised: 7/2016