Skip to Content

ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Restoring Even Skin Tone

Dosage form: kit
Ingredients: ; TITANIUM DIOXIDE 0.08g in 1g
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-156

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 Restoring Even Skin Tone

Drug Facts

Active ingredient

Titanium Dioxide 8%

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 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.
    -
    Wear long-sleeved shirts, pants, hats and sunglasses.
  • 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 42851-156-60

ZO® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM

For Restoring Even Skin Tone

Established Pharmacological Class
SubstancePharmacological Class
RETAMAX Active Vitamin A Micro Emulsion CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
BRIGHTENEX Skin Brightener and Correcting, Non-Hydroquinone CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
RESTORACALM Soothing Recovery CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR RESTORING EVEN SKIN TONE  
titanium dioxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-156
Packaging
#Item CodePackage Description
1NDC:42851-156-601 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 30 mL
Part 21 TUBE 30 mL
Part 31 TUBE 60 g
Part 41 TUBE 30 mL
Part 51 BOTTLE, PUMP 30 mL
Part 1 of 5
RETAMAX ACTIVE VITAMIN A MICRO EMULSION  
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
CETEARYL ISONONANOATE 
CYCLOMETHICONE 5 
GLYCERIN 
CYCLOMETHICONE 6 
CETOSTEARYL ALCOHOL 
STEARETH-20 
PENTYLENE GLYCOL 
CETYL ALCOHOL 
SUNFLOWER OIL 
RETINOL 
PROPYLHEPTYL CAPRYLATE 
POLYSORBATE 20 
CETEARYL GLUCOSIDE 
CAPRYLYL GLYCOL 
1,2-HEXANEDIOL 
APRICOT KERNEL OIL 
CARBOXYPOLYMETHYLENE 
BROCCOLI 
POLYISOBUTYLENE (1300 MW) 
.ALPHA.-TOCOPHEROL ACETATE 
ASCORBYL PALMITATE 
POTASSIUM SORBATE 
BUTYLENE GLYCOL 
LECITHIN, SOYBEAN 
HYDROLYZED SERICIN (ENZYMATIC; 2500 MW) 
SODIUM SULFITE 
SODIUM METABISULFITE 
SODIUM HYDROXIDE 
EDETATE DISODIUM 
CYCLOMETHICONE 4 
STEARYL ALCOHOL 
SORBITAN ISOSTEARATE 
MYRISTYL ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
LINALYL ACETATE 
CURDLAN 
XANTHAN GUM 
PHENOXYETHANOL 
HEXYLENE GLYCOL 
BUTYLATED HYDROXYANISOLE 
PELARGONIUM GRAVEOLENS FLOWER OIL 
ETHYL NICOTINATE 
Sodium Benzoate 
Benzoic Acid 
CARVOMENTHONE 
LAVANDULA ANGUSTIFOLIA FLOWERING TOP 
.ALPHA.-OCIMENE, (3Z)- 
4-CARVOMENTHENOL 
TOCOPHEROL 
EXT. D&C VIOLET NO. 2 
Packaging
#Item CodePackage Description
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/2012
Part 2 of 5
BRIGHTENEX SKIN BRIGHTENER AND CORRECTING, NON-HYDROQUINONE  
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
CETEARYL ISONONANOATE 
CYCLOMETHICONE 5 
GLYCERIN 
ALMOND OIL 
CYCLOMETHICONE 6 
CETOSTEARYL ALCOHOL 
STEARETH-20 
CETYL ALCOHOL 
PENTYLENE GLYCOL 
ASCORBYL GLUCOSIDE 
POLYSORBATE 20 
RETINOL 
CARBOXYPOLYMETHYLENE 
EDETATE DISODIUM 
CYCLOMETHICONE 4 
CETEARYL GLUCOSIDE 
APRICOT KERNEL OIL 
EGG PHOSPHOLIPIDS 
SODIUM HYDROXIDE 
ASCORBYL PALMITATE 
GLUTATHIONE 
.ALPHA.-TOCOPHEROL ACETATE 
PROPYLHEPTYL CAPRYLATE 
TOCOPHEROL 
N-ACETYLGLUCOSAMINE 
SODIUM CHLORIDE 
1,2-HEXANEDIOL 
CAPRYLYL GLYCOL 
POTASSIUM SORBATE 
MALTODEXTRIN 
LECITHIN, SOYBEAN 
SOY ISOFLAVONES 
POLYSORBATE 61 
ALCOHOL 
NYLON-12 
SODIUM SULFITE 
SODIUM METABISULFITE 
CORN OIL 
.BETA.-CAROTENE 
BUTYLATED HYDROXYTOLUENE 
BUTYLATED HYDROXYANISOLE 
SODIUM BENZOATE 
GLUCONOLACTONE 
POLYISOBUTYLENE (1300 MW) 
SORBITAN ISOSTEARATE 
LAVENDER OIL 
GERANIUM OIL, ALGERIAN TYPE 
Packaging
#Item CodePackage Description
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/2012
Part 3 of 5
ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50  
titanium dioxide lotion
Product Information
Item Code (Source)NDC:42851-052
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.08 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
STEARIC ACID 
CYCLOMETHICONE 5 
ALUMINUM HYDROXIDE 
PHENYL TRIMETHICONE 
EDETATE DISODIUM 
PENTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
LAURYL LACTATE 
ISODECYL NEOPENTANOATE 
DIISOPROPYL SEBACATE 
POLYACRYLAMIDE (1500 MW) 
SODIUM DIHYDROXYCETYL PHOSPHATE 
PHYTOSPHINGOSINE 
HYDROGENATED PALM GLYCERIDES 
MELAMINE 
ERYTHRITOL 
HOMARINE HYDROCHLORIDE 
NEPHELIUM LAPPACEUM FRUIT RIND 
SILICON DIOXIDE 
C13-14 ISOPARAFFIN 
LAURETH-7 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
PEG-100 STEARATE 
GLYCERYL MONOSTEARATE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
CHLORPHENESIN 
ETHYLHEXYLGLYCERIN 
SODIUM BENZOATE 
POTASSIUM SORBATE 
Packaging
#Item CodePackage Description
1NDC:42851-052-6060 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/01/2013
Part 4 of 5
RESTORACALM SOOTHING RECOVERY  
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
BUTYLENE GLYCOL 
BIOSACCHARIDE GUM-4 
SHEA BUTTER 
ETHYLHEXYL PALMITATE 
JOJOBA BUTTER 
CURDLAN 
GLYCERIN 
C10-30 CHOLESTEROL/LANOSTEROL ESTERS 
CETYL ALCOHOL 
DICAPRYLYL CARBONATE 
ISONONYL ISONONANOATE 
ETHYLHEXYL ISONONANOATE 
ARACHIDYL GLUCOSIDE 
PEG-100 STEARATE 
GLYCERYL MONOSTEARATE 
ARACHIDYL ALCOHOL 
DOCOSANOL 
DIMETHICONE 
CAPRYLYL GLYCOL 
N-ACETYLTYROSINE 
HYDROLYZED JOJOBA ESTERS (ACID FORM) 
LECITHIN, SOYBEAN 
HYDROLYZED SERICIN (ENZYMATIC; 2500 MW) 
PHENOXYETHANOL 
SUNFLOWER OIL 
ETHYL FERULATE 
POLYGLYCERYL-10 OLEATE 
ROSEMARY 
URIDINE MONOPHOSPHATE DISODIUM 
SULFURYL FLUORIDE 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
1,2-HEXANEDIOL 
PROLINE 
RETINOL 
POTASSIUM HYDROXIDE 
POLYSORBATE 20 
DEHYDROACETIC ACID 
ANGELICA SINENSIS ROOT 
ADENOSINE TRIPHOSPHATE 
HEXYLENE GLYCOL 
EDETATE DISODIUM 
POTASSIUM SORBATE 
XANTHAN GUM 
BUTYLATED HYDROXYTOLUENE 
BUTYLATED HYDROXYANISOLE 
Packaging
#Item CodePackage Description
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/2012
Part 5 of 5
OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA  
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
WATER 
CETEARYL ISONONANOATE 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
PENTYLENE GLYCOL 
RETINOL 
EGG PHOSPHOLIPIDS 
POLYSORBATE 20 
GLYCERIN 
STEARETH-20 
CETOSTEARYL ALCOHOL 
JOJOBA BUTTER 
VITAMIN A PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE 
CURDLAN 
LACTOSE, UNSPECIFIED FORM 
ORANGE OIL 
MANDARIN OIL 
LEMON OIL 
PEPPERMINT OIL 
MIMOSA TENUIFLORA BARK 
ARABIDOPSIS THALIANA 
C14-22 ALCOHOLS 
CETEARYL GLUCOSIDE 
C12-20 ALKYL GLUCOSIDE 
POWDERED CELLULOSE 
BUTYLENE GLYCOL 
PALMITOYL HEXAPEPTIDE-12 
PALMITOYL TETRAPEPTIDE-7 
SODIUM HYDROXIDE 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
HYPROMELLOSES 
HEXYLENE GLYCOL 
EDETATE DISODIUM 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
LIMONENE, (+/-)- 
ULTRAMARINE BLUE 
EXT. D&C VIOLET NO. 2 
Packaging
#Item CodePackage Description
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/11/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35205/01/2014
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
THIBIANT INTERNATIONAL, INC.083913913MANUFACTURE(42851-156)
Establishment
NameAddressID/FEIOperations
SANITOR CORPORATION797472792MANUFACTURE(42851-156)
Establishment
NameAddressID/FEIOperations
Lifetech Resources622559110MANUFACTURE(42851-156)
Establishment
NameAddressID/FEIOperations
PAKLAB790530976MANUFACTURE(42851-156)

 
ZO Skin Health, Inc.

Medically reviewed on Apr 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide